Group Medical Director

Role Summary

Group Medical Director manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and PST leads (and could support one large product as the PST Lead) and ensuring safety of late stage and post marketing Solid Tumor-oncology portfolio. Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Responsibilities

• Connectors within R&D particularly with key functions (Reg, ASL, Risk Mgt, etc)
• Asset strategy lead safety representatives for larger programs (late stage)
• Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery
• Works closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA
• Leads and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA
• Proactively seeks to understand ‚ÄúWHY‚Äù a safety concern or risk emerge and ‚ÄúHow‚Äù to mitigate it
• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Responsible for safety surveillance for pharmaceutical / biological / drug ‚Äìdevice combined products
• Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
• Effectively write, review and provide input on technical documents independently
• Oversight and responsibility for leading the strategy for periodic reports (PSUR‚Äôs, PADER‚Äôs etc.)
• Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
• Responsible for implementing risk management strategies for assigned products
• Proactively engaging, inspiring, coaching and mentoring team and colleagues
• Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
• Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval related activities.

Qualifications

• MD / DO with 2+ years of residency with patient management experience
• Master Public Health or PhD is preferred in addition to MD / DO, not required
• 8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations / opinions in group environment both internally and externally
• Write, review and provide input on technical documents
• Work collaboratively and lead cross-functional teams
• Ability to lead cross-functional teams in a collaborative environment
• Fluency, both written and oral, in English
• Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask

Experiences / Leadership traits

• Ability to work collaboratively with colleagues with different areas of expertise (e.g epidemiology, statistics)
• Ability to make independent decisions
• Ability to influence cross functional stakeholders - internal and across industry, and regulatory authorities
• A clear understanding of PV and clinical development and monitoring clinical trial and post -marketing safety
• Ability to respect other opinions and be inclusive of the different point of views and be open to the ideas of others