[{"additionalPlain":" \nRezolute (RZLT) currently anticipates the base salary for the Director Global Regulatory Lead role could range from $240,000 to $290,000 and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.\n \nQualifying employees are eligible to participate in benefit programs such as:\n \nHealth Insurance (Medical / Dental / Vision)\nDisability, Life & Long-Term Care Insurance\nHoliday Pay\nTracking Free Vacation Program\n401(k) Plan Match\nEducational Assistance Benefit\nFitness Center Reimbursement\n \nWe are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.\n \n \n \n","additional":"\n
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Rezolute (RZLT) currently anticipates the base salary for the Director Global Regulatory Lead role could range from $240,000 to $290,000 and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
\n
\n
Qualifying employees are eligible to participate in benefit programs such as:
\n
\n
\n- Health Insurance (Medical / Dental / Vision)
\n- Disability, Life & Long-Term Care Insurance
\n- Holiday Pay
\n- Tracking Free Vacation Program
\n- 401(k) Plan Match
\n- Educational Assistance Benefit
\n- Fitness Center Reimbursement
\n
\n
\n
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
\n
\n
\n
\n
\n
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
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The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies, and programs pertaining to development and marketing of Rezolute products. This role includes the support of global registration and life cycle support and includes the leadership of regulatory strategy for multiple projects that extend globally (EU, ROW, etc.) coordinating departmental and cross functional support. Position reports to the Chief Regulatory Officer
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Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations. Single point of contact and accountability for regulatory and leads the regulatory sub teams as well as represents regulatory on global development teams.\n
Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for assigned projects.\n
Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., CTAs, MAAs and other relevant regulatory filings.\n
Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.\n
Oversee ex-US regulatory representatives and consultants\n
Provides guidance to all appropriate departments to assure compliance with applicable regulations. \n
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel.\n
Makes recommendations for regulatory department operating procedures.\n
May be involved in participating as the Regulatory reviewer in formal MLR and Promotional Review Board activities\n
May be responsible for creating and reviewing SOPs.\n
May supervise Regulatory Affairs Associates.\n
Consistently works with abstract ideas or situations across functional areas of the business.\n
Through assessment of intangible variables, identifies and evaluates fundamental issues providing strategy and directions for major functional areas.\n
Requires in-depth knowledge of the functional area, business strategies, and the company’s goals.\n\n
\n
Education:
\n\n
BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.\n\n
\n
Experience:
\n\n
Has 8-15 years of Regulatory Affairs experience. The regulatory experience should be broad (across the life cycle of pharmaceutical products through commercialization and across main regions such as US, EU, Japan, and Canada and other) to ensure appropriate leadership and mentoring for regulatory staff within Rezolute.\n
Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s).\n
Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.\n\n\n
Ability to present complex issues in oral and written form.\n
Experienced in responding to inquiries from HAs.\n\n
\n
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
\n
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The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies, and programs pertaining to development and marketing of Rezolute products. This role includes the support of global registration and life cycle support and includes the leadership of regulatory strategy for multiple projects that extend globally (EU, ROW, etc.) coordinating departmental and cross functional support. Position reports to the Chief Regulatory Officer
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Rezolute (RZLT) currently anticipates the base salary for the Executive Director, Payer Strategy and Engagement role could range from $290,000 to $320,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
\n
\n
This role is based in the home office and requires minimum of 3 days per week in the office.
\n
\n
Qualifying employees are eligible to participate in benefit programs such as:
\n
\n
\n- Health Insurance (Medical / Dental / Vision)
\n- Disability, Life & Long-Term Care Insurance
\n- Holiday Pay
\n- Tracking Free Vacation Program
\n- 401(k) Plan Match
\n- Educational Assistance Benefit
\n- Fitness Center Reimbursement
\n
\n
\n
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
\n
\n
\n
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
\n
Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders.
\n
\n- Provide critical leadership and above-country market access strategies including core disease models, value stories, global pricing, economic modeling, and input into Clinical Development programs.
\n- Work closely with Medical Affairs colleagues, Organized customers and Distribution providers to identify real-world and patient quality of life data capture / evidence value solutions and publication opportunities.
\n- Monitors healthcare legislative trends, understands healthcare policies, assesses implications of policies, and develops reimbursement strategies that address barriers to provider and patient access.
\n- Understands total cost of care and all aspects of reimbursement (coverage, coding, and payment) for outpatient and inpatient settings across multiple payer segments.
\n- Support the formulation of a clear and compelling disease and product value propositions through the creation of payer engagement (AMCP Dossier, Value and Economic Prop.), and provider / patient reimbursement support tools.
\n- Monitor the competition to understand how the evolving market will impact current and future market access strategies.
\n- Identify and develop pricing recommendations, coding and reimbursement strategies for current and pipeline assets that will support future Pricing and Reimbursement decisions in the US and other key Ex-US markets.
\n- Engage to support the advancement of ICD-10 CM coding initiatives, and product-specific HCPCS coding application.
\n- Identify product market access risks and opportunities, incorporate them into pipeline product strategies and reflect them in identified Target Product Profiles.
\n- Identify pricing and reimbursement analogues to support value and access decisions.
\n- Create payer materials for branded and unbranded disease awareness campaigns.
\n- Support the identification, creation of defensible, performance driven, quality / outcomes or risked based product / portfolio contract, or rebate opportunities.
\n- Manage agency relationships and contracts to deliver tools/tactics/resources, and ensure on time delivery, that is aligned with the departmental budget.
\n- Provide subject matter expertise to the broader organization, including competitive and product coverage access intelligence, healthcare reform, landscape trends, and pull-through initiatives. This includes cross-functional support of corp. training initiatives, content, tools and presentation development in partnership with Training and Cross-Departmental leaders.
\n- Represent Rezolute at Key Industry Conferences (e.g. AMCP, PCMA, ISPOR, Asembia, etc.).
\n- Ensure that all activities and interactions are carried out with the highest ethical and professional standards, and that all work is accomplished with quality and in accordance with Rezolute values.
\n- Manage/recruit in-house or contracted payer account team to educate key payers using PIE (Payer Information Exchange) before approval and PVP (Payer Value Proposal) after the approval
\n- Educate payers on the label and influence them to develop policies based on the label and/or clinical trial exclusion criteria
\n- Resolve rejection/prior authorization issues by closely working with the payers and patients support services team and hub in a timely manner
\n\n
"},{"text":"QUALIFICATIONS","content":"\n
\n- Experience with rare/orphan drugs is required. Therapeutic area experience is a plus.
\n- Product launch experience is required, and company start-up experience is preferred.
\n- Familiarity with current legal and regulatory landscape pertinent to the pharmaceutical/biotechnology industry.
\n- Strong analytical capabilities, with working knowledge of government pricing practices (calculations methodologies, HTA, healthcare programs, and supporting regulations), and trade systems and processes.
\n- Demonstrated flexibility to adapt to a changing environment, implement creative solutions to complex problems, and ability to function in a project leadership role.
\n- Ability to develop and maintain strong internal and external relationships, including direct collaboration with vendors and other third parties.
\n- Superior interpersonal, oral and written communication, and presentation skills, with great attention to detail.
\n- Leads with strong business acumen and a compliance mindset.
\n- Passionate about patients and building a new commercial organization.
\n- Advanced Microsoft Excel, Word and PowerPoint skills.
\n\n
\n
\n- Minimum Bachelor’s degree required; sciences or business preferred, advanced degree related medical, health economics, health outcomes research, or epidemiology (MS, MBA, MPH, MD/DO, PhD, PharmD) preferred.
\n- Minimum of 10 years of overall industry experience in biotech or pharmaceuticals (i.e. market access and reimbursement, sales, sales management, marketing, training, sales operations, or healthcare / life sciences consulting).
\n- 5 years of US market access and reimbursement experience required, with Global and/or international experience preferred. This includes, HTA, US Payer, Patient and Provider access, HEOR, and medical benefit reimbursement coding expertise.
\n\n
\n
\n
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
\n
Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders.
\n
\n
Rezolute (RZLT) currently anticipates the base salary for the Executive Director/Vice President of Commercial Operations role could range from $290,000 to $340,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
\n
Qualifying employees are eligible to participate in benefit programs such as:
\n
\n- Health Insurance (Medical / Dental / Vision)
\n- Disability, Life & Long-Term Care Insurance
\n- Holiday Pay
\n- Tracking Free Vacation Program
\n- 401(k) Plan Match
\n- Educational Assistance Benefit
\n- Fitness Center Reimbursement
\n
\n
\n
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
\n
\n
\n
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
\n
Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders.
\n
\n
Position Summary
\n
We are seeking a dynamic and experienced Executive Director/Vice President of Commercial Operations to establish and lead all operational aspects of our commercial strategy in support of the launch of our first rare disease therapy. This includes managing commercial operations functions ensuring the infrastructure, processes, and strategies necessary for successful product launch. This individual will be a strategic and hands-on leader responsible for building and managing critical commercial infrastructure, including sales operations, analytics, forecasting, market access operations, and commercial systems. This role oversees sales operations, forecasting and analytics, incentive compensation, market research, data management, CRM systems, field effectiveness, and commercial training.
\n
The ideal candidate has experience in rare disease or specialty pharmaceutical markets and thrives in an entrepreneurial, fast-paced environment. The ideal candidate has experience in rare disease or specialty pharmaceutical markets and thrives in an entrepreneurial, fast-paced environment.
\n
This role is based in the home office and requires minimum of 3 days per week in the office.
\n
\n- Serve as a key member of the Commercial Leadership Team, developing and executing commercial strategy and operations plans.
\n- Develop and execute the commercial operations infrastructure to support a successful rare disease product launch.
\n- Lead commercial planning processes, including sales forecasting, demand planning, incentive compensation design, and territory alignment.
\n- Build and oversee a high-functioning sales operations team and associated systems (CRM, data warehousing, reporting dashboards).
\n- Establish data governance processes and manage third-party vendors providing data (claims, specialty pharmacy, distribution).
\n- Partner cross-functionally with Market Access, Marketing, Medical Affairs, Finance, and IT to ensure alignment of commercial operations with overall corporate goals.
\n- Design and manage KPIs and reporting frameworks to track performance and inform commercial decision-making.
\n- Lead field force enablement efforts, including CRM configuration, targeting, call planning, and field reporting.
\n- Support the development of compliant policies and processes for commercial activities in collaboration with Legal and Compliance teams.
\n- Manage operational budgets, contracts, and vendor relationships for commercial functions.
\n
"},{"text":"Qualifications:","content":"\n
\n- Bachelor’s degree required; MBA or advanced degree preferred.
\n- 10+ years of progressive experience in commercial operations within the biopharmaceutical industry, including at least 5 years in a leadership role.
\n- Direct experience supporting launch planning and execution for rare disease or specialty products.
\n- Deep understanding of commercial data sources (e.g., specialty pharmacy, HUB services, patient services, claims data).
\n- Demonstrated success in building commercial infrastructure in a high-growth or startup environment.
\n- Strong project management skills, attention to detail, and ability to lead cross-functional initiatives.
\n- Excellent communication and leadership skills with a collaborative approach.
\n- Familiarity with compliance regulations in the rare disease space.
\n\n
\n\n
Preferred Attributes
\n
\n- Experience in both pre-commercial and commercial-stage biotech organizations.
\n- Entrepreneurial mindset and comfort operating in a fast-paced, evolving environment.
\n- Ability to work in a lean organization with a hands-on, roll-up-your-sleeves style.
\n- Passion for serving patients with serious or underserved diseases.
\n\n
\n
\n
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
\n
Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders.
\n
\n
Position Summary
\n
We are seeking a dynamic and experienced Executive Director/Vice President of Commercial Operations to establish and lead all operational aspects of our commercial strategy in support of the launch of our first rare disease therapy. This includes managing commercial operations functions ensuring the infrastructure, processes, and strategies necessary for successful product launch. This individual will be a strategic and hands-on leader responsible for building and managing critical commercial infrastructure, including sales operations, analytics, forecasting, market access operations, and commercial systems. This role oversees sales operations, forecasting and analytics, incentive compensation, market research, data management, CRM systems, field effectiveness, and commercial training.
\n
The ideal candidate has experience in rare disease or specialty pharmaceutical markets and thrives in an entrepreneurial, fast-paced environment. The ideal candidate has experience in rare disease or specialty pharmaceutical markets and thrives in an entrepreneurial, fast-paced environment.
\n
This role is based in the home office and requires minimum of 3 days per week in the office.
\n
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Rezolute (RZLT) currently anticipates the base salary for the Manager Clinical Supply Chain role could range from $140,000 to $165,000 and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
\n
\n
Qualifying employees are eligible to participate in benefit programs such as:
\n
\n
\n- Health Insurance (Medical / Dental / Vision)
\n- Disability, Life & Long-Term Care Insurance
\n- Holiday Pay
\n- Tracking Free Vacation Program
\n- 401(k) Plan Match
\n- Educational Assistance Benefit
\n- Fitness Center Reimbursement
\n
\n
\n
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
\n
\n
\n
\n
\n
Rezolute is a biopharmaceutical company seeking an experienced individual who can help lead its external late-stage to commercial manufacturing operations. Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).
\n
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Position Description
\n
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The Manager, Clinical Supply Chain is responsible for the execution and management of end-to-end clinical supply activities to ensure the uninterrupted supply of Investigational Product (IP) to Rezolute’s clinical trials and Named Patient programs.
\n
\n
This role partners cross-functionally with Technical Operations, Clinical Operations, Quality, and Subject Matter Experts (SME) to support global supply, production, and distribution strategies and represents the Clinical Supply Chain team on study teams to enable successful trial execution.
\n
\n
The individual will work amongst a team in a matrix organization, capitalizing on each other’s expertise in a highly collaborative and agile environment to advance a pipeline of metabolic disease and orphan drug therapeutics. Ability to work in a highly collaborative, virtual, entrepreneurial environment leveraging external collaborations to accomplish individual and team goals.
\n
\n
Reporting to the Associate Director, Global Supply Chain, this role is Redwood City based.
\n
\n
\n
\n- Partner cross-functionally to support a quality-focused, patient-first supply chain network
\n- Execute clinical supply activities across multiple studies, aligning with trial timelines and company priorities
\n- Manage global IP, including distribution, inventory, forecasting, and supply planning; oversee returns, reconciliation, and destruction
\n- Interpret protocols and collaborate with study and supply chain teams to ensure the right-first-time delivery of IP globally
\n- Coordinate import licenses and other critical steps to ensure on-time delivery of IP
\n- Works collaboratively with Clinical Operations to specify, set up, test, validate, and operate an IRT. Act as an Unblinded Drug Manager within IRT
\n- Manage vendors supporting clinical labeling, packaging, storage, and distribution; monitor performance and escalate as needed
\n- Support clinical label development processes, including content, design, approval, and translations
\n- Develop and maintain clinical demand forecasting models for assigned clinical studies, including Expanded Access Programs
\n- Identify supply risks and support the implementation of mitigation plans to avoid supply disruptions
\n- Engage in supply chain process improvements to support regulatory compliance and agency inspection readiness
\n- Ensure clinical supply activities comply with cGMP, GDP, and relevant global/country-specific regulations; support eTMF filings
\n- Support financial planning and cost management for clinical supplies, including budgeting, forecasting, and cost tracking
\n\n
\n
\n- Bachelor’s degree required, with at least 5 years of experience in a highly regulated pharmaceutical clinical supply chain role
\n- Experience executing global clinical distribution activities, including last-mile delivery of temperature-controlled IP
\n- Experience supporting blinded, Phase 1-3 studies and Expanded Access Programs
\n- Strong knowledge of current Good Manufacturing Practices (cGMP) and global regulatory requirements governing clinical supply
\n- Import/export logistics experience in a GxP environment
\n- Hands-on experience configuring and managing supply chain functions within IRT, as well as participating in UAT process
\n- Experience working with CMO and third-party vendors
\n- Must be willing to travel domestically and internationally as required (up to 5%)
\n\n
\n
\nPreferred Experience, Special Skills and Knowledge:
\n
\n\n- Strong leadership skills and ability to effectively communicate up, down and across the organization
\n- Ability to effectively prioritize and deliver high-quality results on tight timelines
\n- Excellent written, verbal communication and presentation skills
\n- Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues
\n- Act with HONOR: Honesty, Open with Direct Communication, Nimbleness, Open-minded,
\n- Respect
\n\n
\n
\n
\n
Rezolute is a biopharmaceutical company seeking an experienced individual who can help lead its external late-stage to commercial manufacturing operations. Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).
\n
\n
Position Description
\n
\n
The Manager, Clinical Supply Chain is responsible for the execution and management of end-to-end clinical supply activities to ensure the uninterrupted supply of Investigational Product (IP) to Rezolute’s clinical trials and Named Patient programs.
\n
\n
This role partners cross-functionally with Technical Operations, Clinical Operations, Quality, and Subject Matter Experts (SME) to support global supply, production, and distribution strategies and represents the Clinical Supply Chain team on study teams to enable successful trial execution.
\n
\n
The individual will work amongst a team in a matrix organization, capitalizing on each other’s expertise in a highly collaborative and agile environment to advance a pipeline of metabolic disease and orphan drug therapeutics. Ability to work in a highly collaborative, virtual, entrepreneurial environment leveraging external collaborations to accomplish individual and team goals.
\n
\n
Reporting to the Associate Director, Global Supply Chain, this role is Redwood City based.
\n
\n
\n
Rezolute (RZLT) currently anticipates the base salary for Marketing Operations Director role could range from $240,000 to $290,000 and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
\n
\n
Qualifying employees are eligible to participate in benefit programs such as:
\n
\n
\n- Health Insurance (Medical / Dental / Vision)
\n- Disability, Life & Long-Term Care Insurance
\n- Holiday Pay
\n- Tracking Free Vacation Program
\n- 401(k) Plan Match
\n- Educational Assistance Benefit
\n- Fitness Center Reimbursement
\n
\n
\n
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
\n
\n
\n
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
\n
\n
Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders.
\n
\n
The Marketing Operations Director will play a crucial role in executing the launch of Rezolute’s lead product, ersodetug, in tumor-associated hyperinsulinism (Tumor HI). Reporting to the Vice President of Commercial Strategy, this role will be responsible for operational leadership, process optimization, event planning, project management, and fulfillment. This role will also work closely with cross-functional teams to ensure operational excellence across Commercial initiatives. This role is based in the home office and requires minimum of 3 days per week in the office.
\n
\n
\n- Lead the development, implementation, and management of marketing operations processes, systems, and best practices.
\n- Provide project management support with planning and execution of the marketing strategy, ensuring compliance with regulatory guidelines and alignment with business objectives.
\n- Support the Medical Legal Regulatory (MLR) review committee, collaborating with key cross-functional stakeholders to ensure timely review and approval of all promotional and educational materials in compliance with FDA, regulatory, and legal standards.
\n- Coordinate logistics for Advisory Boards, focus groups, and regional conferences, including budgeting, vendor management, material delivery, and where necessary, on-site support.
\n- Post-FDA approval, lead cross-functional planning and execution for national conferences to raise brand awareness at congresses including NANETS, ENDO, and ASCO.
\n- Build and oversee relationships with external fulfillment houses, including internal training, to ensure the effective distribution and inventory management of promotional and educational materials, ensuring timely fulfillment of requests.
\n- Lead contracting across Marketing, including MSAs, SOWs, work orders and invoicing.
\n- Collaborate closely with the Commercial Data Analytics team to help define the marketing technology stack (e.g., CRM, marketing automation platforms, analytics tools), ensuring tools are integrated effectively and support campaign execution.
\n- Collaborate with external vendors and agencies for campaign execution and ensure adherence to timelines, budget, and compliance guidelines. Develop and manage marketing budgets, including monthly reconciliation.
\n\n
\n
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
\n
\n
Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders.
\n
\n
The Marketing Operations Director will play a crucial role in executing the launch of Rezolute’s lead product, ersodetug, in tumor-associated hyperinsulinism (Tumor HI). Reporting to the Vice President of Commercial Strategy, this role will be responsible for operational leadership, process optimization, event planning, project management, and fulfillment. This role will also work closely with cross-functional teams to ensure operational excellence across Commercial initiatives. This role is based in the home office and requires minimum of 3 days per week in the office.
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Rezolute (RZLT) currently anticipates the base salary for the Senior Medical Science Liaison role could range from $170,000 to $220,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
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\nQualifying employees are eligible to participate in benefit programs such as:
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\n· Health Insurance (Medical / Dental / Vision)
\n· Disability, Life & Long-Term Care Insurance
\n· Holiday Pay
\n· Tracking Free Vacation Program
\n· 401(k) Plan Match
\n· Educational Assistance Benefit
\n· Fitness Center Reimbursement
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\nWe are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
","categories":{"department":"Medical and Patient Affairs","location":"Remote","team":"Medical Science Liaison","allLocations":["Remote","Redwood City"]},"createdAt":1775669309259,"descriptionPlain":"Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).\n \n \nThe Senior Medical Science Liaison (Sr.MSL) will join a newly developed Medical Affairs Department. Sr.MSLs are responsible for developing and enhancing professional relationships with medical thought leaders within the metabolic and oncologic space. MSLs provide medical information through scientific exchange, and clinical/scientific support for Rezolute and the Medical Affairs department. This is a work position requires professionals with established personal and scientific credibility to interact with global thought leaders and academic centers of excellence.\n \nEssential Functions\n","description":"Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).
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\nThe Senior Medical Science Liaison (Sr.MSL) will join a newly developed Medical Affairs Department. Sr.MSLs are responsible for developing and enhancing professional relationships with medical thought leaders within the metabolic and oncologic space. MSLs provide medical information through scientific exchange, and clinical/scientific support for Rezolute and the Medical Affairs department. This is a work position requires professionals with established personal and scientific credibility to interact with global thought leaders and academic centers of excellence. \n
\nEssential Functions
","id":"0876533b-5b22-47c8-9db7-4dff00a7fbc4","lists":[{"text":"KOL Development and Field Engagement:","content":"\nIdentify and develop peer-to-peer relationships with key opinion leaders (KOLs) and healthcare providers within relevant Metabolic and Oncology therapeutic areas\nIdentify new, up and coming thought leaders within target therapeutic areas\nDevelop and execute projects and program material in alignment with evolving launch readiness plans\nIdentify and communicate key clinical and research issues and insights from KOLs to appropriate departments\nParticipate in medical education for healthcare professionals (HCPs) through virtual/on-site presentations at healthcare institutions, investigator meetings, national/international conferences, advisory boards, or regional meetings\nProvide scientific support for additional activities such as medical congress staffing, advisory boards, and internal and external training initiatives\n"},{"text":"Positions self as Scientific Expert","content":"\nMaintains an up to date and high-level knowledge of the therapy area, Rezolute products, new and emerging areas of research, therapeutic issues and trends, and competitive landscape.\nEstablishes reputation as a trustworthy and knowledgeable source of scientific and medical information for the healthcare community.\nSupports development of Rezolute positioning as the scientific authority in Metabolism & Oncology therapeutic space. Attends appropriate scientific congresses to stay abreast of developments and to support International, National, Regional and local KOL activities and Rezolute interests.\nAcquires a broad understanding of local, national and international protocols and standards of clinical practice and trends in disease management.\nProvide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, and healthcare provider settings in both group and one-on-one situations\nCommunicates emerging data and the clinical experience with our products through scientific exchange and peer-to-peer interactions discussing benefits and risks in an objective manner.\nProvide support for data generation activities (company-sponsored studies, collaboration studies, ISTs and Rezolute’s Expanded Access Program)\nProvide scientific support for additional activities such as medical congress staffing, advisory boards, and sales training initiatives\n"},{"text":"Medical Affairs Planning and Plan Execution","content":"\nContributes to the development of the launch readiness plans and provides input into strategies and tactics.\nWhere needed, manages relevant budget to enable execution of Medical Affairs tactics as part of the wider launch readiness team.\nWorks in a collaborative manner with cross-functional colleagues to meet defined strategic imperatives and critical success factors.\nInteracts with HCPs as a scientific resource to support activities aligned with launch readiness plans including advisory boards, speaker development, publication plans and clinical trials, as appropriate.\n"},{"text":"Evidence Generation and Life Cycle Management: Strategic development and execution of data generation plans to support pipeline assets.","content":"\nCollaborate cross-functionally with Clinical Development, Medical Affairs, Regulatory, and HEOR teams to align data strategies.\nIdentify, assess, and prioritize data gaps across the product lifecycle in alignment with clinical, medical, and future commercial objectives.\nFacilitate advisory boards and expert consultations to validate data gaps and ensure scientific and clinical relevance.\nHelp in the development of key processes/SOPs that delineate the IIST/RWE process from proposal and protocol to contracting and publication.\nLeverage KOL insights, congress findings, and emerging literature to refine evidence generation strategies.\nAlign data activities with regulatory submission requirements, payer evidence needs, and competitive differentiation strategies.\nMonitor competitive landscape and scientific trends to proactively adjust product strategies and sustain market differentiation.\n"},{"text":"Responsible for maintaining Company standards and values","content":"\nConsistently acts to enhance Rezolute’s image as an advocate of medical advancement by using knowledge of product, disease state and pipeline products to engage healthcare providers in meaningful scientific exchange of information.\nDocument and forward reports of adverse events and product complaints according to Rezolute's policy to ensure safe and effective use of Rezolute’s products.\nAdheres to the relevant international, national and local Codes of Practice.\nBehaves ethically and with integrity at all times.\nActs as an ambassador for Rezolute following company mission and values.\nKeeps own written development plan and implements.\nPrepares timely reporting according to the company needs.\n"},{"text":"Required Knowledge, Skills, and Abilities","content":"\nAbility to research, critically analyze and communicate complex scientific/medical information and data.\nClear and concise communication and presentation skills.\nExcellent planning and organization skills, with high-level attention to detail and accuracy.\nStrong strategic mindset.\nHighly self-motivated and ability to work autonomously.\nAbility to learn quickly, be flexible and results-focused in a rapidly changing environment.\nDemonstrated skills in inter-personal relationship building, networking, collaboration and teamwork.\nStrong capabilities working with Microsoft suite of products and other digital platforms and tools are required\nExcellent command of spoken and written English.\nAbility and willingness to travel. Driving may be required.\nKnowledge of healthcare environment and external experts in academia and medical community.\nDemonstrated ability to develop trust and relationships with opinion leaders in disease states of interest.\nUnderstanding of regulatory requirements for field-based personnel\nExperience as a Medical Science Liaison with a strong track record of success is strongly preferred\n"},{"text":"Required Education and Licenses","content":"\nAdvanced medical, clinical, nursing or similar degree (such as MD, PhD, PharmD, NP, PA or equivalent)\nA minimum of 5 years' experience as a MSL or comparable industry or clinical role is required, with a minimum of 2 years’ experience in rare disease.\nThis position will require field activities, and applicants must be willing to travel 60-75% time\nValid driver's license and live within 60 miles of an airport services by at least one major airline.\n"},{"text":"Description of Physical Demands","content":"\nFrequent travel (domestic and international) with potential extended time away from home.\nFrequently operating a computer, printer, telephone and other similar office machinery.\nResponsibilities may require a work schedule that may include working outside of \"normal\" work hours, in order to meet business demands.\nFrequent public contact requiring appropriate business apparel.\n"},{"text":"Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that has:","content":"\nStrong leadership skills and ability to effectively communicate up, down and across the organization\nAbility to effectively prioritize and deliver high-quality results on tight timelines\nExcellent written, verbal communication and presentation skills\nOutstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues\nAct with HONOR: Honesty, Open with Direct Communication, Nimbleness, Open-minded, Respect\n"}],"salaryDescription":"
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","salaryDescriptionPlain":" \n \n","text":"Senior Medical Science Liaison","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).
\n
\n
\nThe Senior Medical Science Liaison (Sr.MSL) will join a newly developed Medical Affairs Department. Sr.MSLs are responsible for developing and enhancing professional relationships with medical thought leaders within the metabolic and oncologic space. MSLs provide medical information through scientific exchange, and clinical/scientific support for Rezolute and the Medical Affairs department. This is a work position requires professionals with established personal and scientific credibility to interact with global thought leaders and academic centers of excellence. \n
\nEssential Functions
","descriptionBodyPlain":"Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).\n \n \nThe Senior Medical Science Liaison (Sr.MSL) will join a newly developed Medical Affairs Department. Sr.MSLs are responsible for developing and enhancing professional relationships with medical thought leaders within the metabolic and oncologic space. MSLs provide medical information through scientific exchange, and clinical/scientific support for Rezolute and the Medical Affairs department. This is a work position requires professionals with established personal and scientific credibility to interact with global thought leaders and academic centers of excellence.\n \nEssential Functions\n","hostedUrl":"https://jobs.lever.co/rezolutebio/0876533b-5b22-47c8-9db7-4dff00a7fbc4","applyUrl":"https://jobs.lever.co/rezolutebio/0876533b-5b22-47c8-9db7-4dff00a7fbc4/apply"},{"additionalPlain":" \nRezolute (RZLT) currently anticipates the base salary for the Sr. Director Commercial Supply Chain role could range from $225,000 to $280,000 and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience, and geographical location of the selected candidate. \n \nQualifying employees are eligible to participate in benefit programs such as:\n \nHealth Insurance (Medical / Dental / Vision)\nDisability, Life & Long-Term Care Insurance\nHoliday Pay\nTracking Free Vacation Program\n401(k) Plan Match\nEducational Assistance Benefit\nFitness Center Reimbursement\n \nWe are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. \n \n \n \n \n","additional":"\n
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Rezolute (RZLT) currently anticipates the base salary for the Sr. Director Commercial Supply Chain role could range from $225,000 to $280,000 and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience, and geographical location of the selected candidate.
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Qualifying employees are eligible to participate in benefit programs such as:
\n
\n
\n- Health Insurance (Medical / Dental / Vision)
\n- Disability, Life & Long-Term Care Insurance
\n- Holiday Pay
\n- Tracking Free Vacation Program
\n- 401(k) Plan Match
\n- Educational Assistance Benefit
\n- Fitness Center Reimbursement
\n
\n
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We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
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Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
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Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders
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Position Summary
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The Sr Director, Commercial Supply Chain will lead supply chain strategy and operations as Rezolute transitions from late-stage clinical development to commercial launch. This individual will establish scalable, compliant, and efficient supply capabilities to ensure uninterrupted supply of investigational and commercial products across global markets. The role requires a strategic, hands-on leader who can design the future-state operating model, build critical systems and partnerships, and lead a growing team through commercialization while supporting ongoing clinical supply operations.
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\n- 15+ years of progressive supply chain leadership experience in pharmaceutical or biotech industry.
\n- Demonstrated ability to provide strategic leadership and influence across functions in a fast-growing, high-pressure environment.
\n- Experience designing and managing US , EU and ROW supply chains for biologics and small molecules.
\n- Deep understanding of GxPs, cold chain logistics, and outsourced manufacturing models.
\n- Proven success in S&OP, supply and inventory planning, and risk management.
\n- In-depth understanding of global trade compliance and import/export regulations.
\n- Proven ability to build, lead, and develop cross-functional teams.
\n- Bachelor’s degree in supply chain management, engineering, life sciences, or related discipline required; MBA or advanced degree preferred.
\n- Demonstrated success leading clinical-to-commercial transition, including launch readiness and supply network establishment.
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\nPreferred Attributes
\n\n- Strong cross-functional collaboration and partnership skills, with the ability to align and execute across diverse technical, operational, and commercial teams.
\n- Prior experience with rare disease or CGT supply chains.
\n- Global product launch and post-approval lifecycle management experience.
\n- ERP systems expertise and familiarity with advanced planning tools.
\n- Demonstrated agility and resourcefulness in fast-paced, scaling environments typical of high-growth biotech organizations.
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Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
\n
\n
Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders
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Position Summary
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The Sr Director, Commercial Supply Chain will lead supply chain strategy and operations as Rezolute transitions from late-stage clinical development to commercial launch. This individual will establish scalable, compliant, and efficient supply capabilities to ensure uninterrupted supply of investigational and commercial products across global markets. The role requires a strategic, hands-on leader who can design the future-state operating model, build critical systems and partnerships, and lead a growing team through commercialization while supporting ongoing clinical supply operations.
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