Medical Director, Medical Affairs (Endocrine-Oncology) (Senior Director-Executive Director Level)
Rezolute, Inc.
2 hours ago
Remote friendly (Redwood City, CA)
United States
Medical Affairs
Medical Director, Medical Affairs (Sr. Director–Executive Director)
Key Responsibilities
- Partner in shaping and delivering the Medical Affairs strategy in endocrine-oncology for RZ358 for hypoglycemia due to tumor-related hyperinsulinism (e.g., insulinomas and non-islet cell tumor hypoglycemia).
- Serve as internal disease area expert for hypoglycemia in the oncology setting; provide strategic input into launch readiness, data generation, and scientific communication.
- Collaborate with Clinical Development and Commercial teams to ensure medical strategy supports clinical evidence needs and market preparedness.
- Develop publication plans, data dissemination strategies, and scientific platforms; integrate insights from field interactions into Medical Affairs strategy and launch readiness.
- Partner with senior medical leadership to ensure consistent messaging, training, and field alignment.
Internal Education & Training
- Lead internal disease and product education; primary trainer for scientific/clinical content on hyperinsulinism pathophysiology in neuroendocrine/non-islet cell tumors, RZ358 mechanism of action, clinical data, and competitive landscape.
- Ensure teams can engage healthcare professionals credibly and compliantly.
- Mentor and coach MSLs.
External Engagement & Thought Leader Collaboration
- Build relationships with oncologists and endocrinologists focused on tumor-related hypoglycemia.
- Identify, engage, and develop KOLs and external experts.
- Represent the company at oncology/endocrinology congresses, advisory boards, and symposia.
- Provide scientific leadership for investigator-initiated studies (IIS), data generation, and collaborative research on hyperinsulinism.
- Capture and synthesize medical insights to inform strategy, publications, and future development.
Medical Affairs Execution
- Execute medical education, data dissemination, and stakeholder engagement plans for RZ358 with field MSLs and launch teams; support standard response documents and Medical Information execution.
- Provide medical oversight for advisory boards, educational programs, and medical materials (accuracy and compliance); support Medical Information via drafting/reviewing/refining standard responses and FAQs.
- Develop scientific slide presentations, FAQs, and materials for internal/external use.
Compliance & Governance
- Ensure Medical Affairs activities adhere to SOPs, regulatory standards, and industry codes.
- Serve as medical reviewer for scientific and promotional materials (accuracy, balance, regulatory/compliance alignment).
- Partner with pharmacovigilance to support safety reporting alignment; act as an ethical ambassador for mission/values.
Required Qualifications
- MD, DO, or equivalent advanced clinical degree; ideally board certification or strong therapeutic expertise in Medical Oncology, Adult Endocrinology, or related specialties.
- Demonstrated success developing and executing medical strategies for launch-stage or commercialized rare disease products; proven success for launch-stage or rare oncology products.
- Strong understanding of neuroendocrine tumor biology and relevant oncologic hypoglycemia conditions.
- Proven experience in field-based Medical Affairs roles (e.g., Senior MSL or Medical Director) with extensive external engagement.
- Ability to translate complex scientific data into clear, actionable insights.
- Experience supporting MLR/PRC reviews or Medical Information processes (preferred).
- Strong collaboration in a fast-paced, matrixed organization; excellent communication, leadership, and presentation skills.
- Ability to travel domestically/internationally (up to ~50%).
Preferred Experience And Attributes
- Minimum 7 years of Medical Affairs experience in biopharmaceutical industry (oncology/endocrine-oncology/neuroendocrine tumors).
- Experience supporting oncology/endocrinology product launches, especially rare tumor indications or metabolic-oncology interfaces.
- Established relationships in oncology/endocrinology/neuroendocrine communities.
- Experience mentoring/leading field medical teams.
- Experience supporting MLR/PRC reviews or Medical Information processes (preferred).
- Strategic thinker with strong execution and organizational skills; high integrity and accountability.
Benefits (as explicitly stated)
- Health Insurance (Medical / Dental / Vision)
- Disability, Life & Long-Term Care Insurance
- Holiday Pay
- Tracking Free Vacation Program
- 401(k) Plan Match
- Educational Assistance Benefit
- Fitness Center Reimbursement
Key Responsibilities
- Partner in shaping and delivering the Medical Affairs strategy in endocrine-oncology for RZ358 for hypoglycemia due to tumor-related hyperinsulinism (e.g., insulinomas and non-islet cell tumor hypoglycemia).
- Serve as internal disease area expert for hypoglycemia in the oncology setting; provide strategic input into launch readiness, data generation, and scientific communication.
- Collaborate with Clinical Development and Commercial teams to ensure medical strategy supports clinical evidence needs and market preparedness.
- Develop publication plans, data dissemination strategies, and scientific platforms; integrate insights from field interactions into Medical Affairs strategy and launch readiness.
- Partner with senior medical leadership to ensure consistent messaging, training, and field alignment.
Internal Education & Training
- Lead internal disease and product education; primary trainer for scientific/clinical content on hyperinsulinism pathophysiology in neuroendocrine/non-islet cell tumors, RZ358 mechanism of action, clinical data, and competitive landscape.
- Ensure teams can engage healthcare professionals credibly and compliantly.
- Mentor and coach MSLs.
External Engagement & Thought Leader Collaboration
- Build relationships with oncologists and endocrinologists focused on tumor-related hypoglycemia.
- Identify, engage, and develop KOLs and external experts.
- Represent the company at oncology/endocrinology congresses, advisory boards, and symposia.
- Provide scientific leadership for investigator-initiated studies (IIS), data generation, and collaborative research on hyperinsulinism.
- Capture and synthesize medical insights to inform strategy, publications, and future development.
Medical Affairs Execution
- Execute medical education, data dissemination, and stakeholder engagement plans for RZ358 with field MSLs and launch teams; support standard response documents and Medical Information execution.
- Provide medical oversight for advisory boards, educational programs, and medical materials (accuracy and compliance); support Medical Information via drafting/reviewing/refining standard responses and FAQs.
- Develop scientific slide presentations, FAQs, and materials for internal/external use.
Compliance & Governance
- Ensure Medical Affairs activities adhere to SOPs, regulatory standards, and industry codes.
- Serve as medical reviewer for scientific and promotional materials (accuracy, balance, regulatory/compliance alignment).
- Partner with pharmacovigilance to support safety reporting alignment; act as an ethical ambassador for mission/values.
Required Qualifications
- MD, DO, or equivalent advanced clinical degree; ideally board certification or strong therapeutic expertise in Medical Oncology, Adult Endocrinology, or related specialties.
- Demonstrated success developing and executing medical strategies for launch-stage or commercialized rare disease products; proven success for launch-stage or rare oncology products.
- Strong understanding of neuroendocrine tumor biology and relevant oncologic hypoglycemia conditions.
- Proven experience in field-based Medical Affairs roles (e.g., Senior MSL or Medical Director) with extensive external engagement.
- Ability to translate complex scientific data into clear, actionable insights.
- Experience supporting MLR/PRC reviews or Medical Information processes (preferred).
- Strong collaboration in a fast-paced, matrixed organization; excellent communication, leadership, and presentation skills.
- Ability to travel domestically/internationally (up to ~50%).
Preferred Experience And Attributes
- Minimum 7 years of Medical Affairs experience in biopharmaceutical industry (oncology/endocrine-oncology/neuroendocrine tumors).
- Experience supporting oncology/endocrinology product launches, especially rare tumor indications or metabolic-oncology interfaces.
- Established relationships in oncology/endocrinology/neuroendocrine communities.
- Experience mentoring/leading field medical teams.
- Experience supporting MLR/PRC reviews or Medical Information processes (preferred).
- Strategic thinker with strong execution and organizational skills; high integrity and accountability.
Benefits (as explicitly stated)
- Health Insurance (Medical / Dental / Vision)
- Disability, Life & Long-Term Care Insurance
- Holiday Pay
- Tracking Free Vacation Program
- 401(k) Plan Match
- Educational Assistance Benefit
- Fitness Center Reimbursement