Senior Medical Director- Early Development Oncology

About the Role

The Product Safety Team (PST) lead for late stage oncology products will collaborate closely with the development medical lead to set the strategy for oncology programs. Under the direction of the Group Lead and TA Head, the PST lead will ensure safety throughout the product lifecycle, including surveillance, signal detection, risk assessment, and mitigation strategies. This role involves working with cross-functional teams such as safety scientists, safety architects, safety PMs, PK/toxicology leads, regulatory and clinical development leads, and medical affairs colleagues to guide dose selection, trial design, and safety monitoring. The PST lead will interpret pharmacovigilance regulations, lead safety components of submissions, and support label updates and risk management plans.

Responsibilities

• Apply pharmacology, chemistry, and non-clinical toxicology knowledge to conduct safety surveillance for pharmaceutical, biological, and drug-device combined products.
• Lead and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses, risk management plans, and NDA/sNDA submissions.
• Analyze and interpret aggregate safety data, communicating findings to cross-functional teams, executive leadership, and external stakeholders as needed.
• Write, review, and provide input on technical documents independently.
• Oversee and lead the strategy for periodic reports (DSURs, PSURs, PADERs, etc.).
• Implement risk management strategies for assigned products.
• Proactively engage, inspire, coach, and mentor team members and colleagues.
• Co-author publications and participate in initiatives to develop and grow as a safety leader.
• Work collaboratively in a fast-paced environment, adapting as needed.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day).

Qualifications

• MD/DO with 2+ years of internal medicine residency and patient management experience required; PhD or Clinical Pharmacology fellowship preferred but not required.
• 2-5 years of Pharmacovigilance or Clinical Development experience in the pharmaceutical industry.
• Oncology experience strongly preferred.
• Ability to analyze and guide the analysis of clinical data and epidemiological information.
• Strong presentation skills for internal and external groups.
• Experience writing, reviewing, and providing input on technical documents.
• Ability to lead cross-functional teams in a collaborative environment.

Benefits

• Comprehensive package including paid time off (vacation, holidays, sick leave).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.