Medical Director, Early Pipeline, Immunology, GPS
About The Position
Serve independently as the Product Safety Team Lead for one or more assigned products in early development, with accountability for leading safety surveillance, signal detection, validation, assessment, and risk management activities. Provide medical and strategic leadership to the Product Safety Team and drive evidence-based safety decisions. Integrate pharmacology, chemistry, clinical data, and nonclinical toxicology to guide product safety strategy. Oversee safety surveillance and pharmacovigilance for investigational products and products in clinical trials, and contribute to key pharmacovigilance documents, including development product safety assessments, regulatory responses, risk management plans, and Development Safety Update Reports (DSURs). Interpret applicable regulatory guidance and regulations to support patient safety and cross-functional decision-making. The role may also support other Product Safety Team Leads and due diligence projects.
Requirements
- MD or DO with at least two years of residency and patient management experience.
- Demonstrated ability to analyze and guide the analysis of preclinical, clinical, and epidemiological data.
- Demonstrated ability to author and critically review technical documents.
- Ability to formulate, clearly present, and defend medical safety assessments and recommendations to cross-functional teams and governance bodies.
- Ability to work collaboratively in a team environment, take initiative, and work independently.
- Fluency in written and spoken English.
Nice To Haves
- Pharmacovigilance experience in the pharmaceutical industry.
Responsibilities
- Independently serve as Product Safety Team Lead for one or more assigned products in early development, providing medical and strategic leadership and driving evidence-based safety decisions.
- Integrate pharmacology, chemistry, clinical data, and nonclinical toxicology to lead safety surveillance and inform product safety strategy.
- Provide safety oversight for pharmaceutical, biological, and drug-device combination investigational products.
- Contribute to the authorship of pharmacovigilance documents, including development product safety assessments, regulatory responses, and risk management plans.
- Interpret and apply current regulatory guidance and pharmacovigilance regulations to safety surveillance, patient safety activities, and cross-functional safety decisions.
- Lead analysis and interpretation of safety data and communicate conclusions and recommendations to cross-functional teams and governance bodies.
- Write, review, and provide input on technical documents.
- Lead the strategy for Development Safety Update Reports (DSURs).
- Oversee safety surveillance and pharmacovigilance activities for products in clinical trials.
- Lead and implement risk management strategies for assigned products, and support other Product Safety Team Leads and due diligence projects as needed.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
