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Medical Director – Pharmacovigilance
Location
United States
Posted
40 days ago
Salary
$285K - $330K / year
Seniority
Lead
Job Description
Medical Director – Pharmacovigilance
Apogee Therapeutics
• Identify emerging safety signals and ensure appropriate escalation through internal safety governance pathways. • Contribute to the development and execution of pharmacovigilance strategies for Apogee clinical programs across various stages of development. • Maintain ongoing benefit–risk assessments incorporating disease severity, unmet medical need, and emerging clinical data. • Collaborate with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries. • Ensure high-quality MedDRA coding, appropriate event characterization, and robust safety narratives. • Lead preparation and review of DSURs, Investigator’s Brochures (IBs), safety sections of protocols, informed consent forms (ICFs), and clinical study reports. • Provide safety input to regulatory submissions (INDs/CTAs), protocol amendments, and responses to health authority inquiries. • Partner with Regulatory Affairs and Quality teams to address safety findings, deviations, and corrective and preventive actions (CAPAs). • Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, and Medical Writing. • Support the development of the Integrated Summary of Safety (ISS), and the safety-related components of the New Drug Applications (NDA)/Biologics License Application (BLA), and Marketing Authorization Applications (MAA), in compliance with global regulatory standards. • Review safety content of scientific publications such as posters, abstracts, and manuscripts.
Job Requirements
- MD degree is required
- Minimum 8 years of pharmacovigilance experience in the biopharmaceutical industry
- Strong expertise in global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH)
- Exposure to biologics, medications for I&I conditions including dermatology and respiratory indications a plus
- Experience in late-stage development and submissions
- Alignment with Apogee C.O.R.E. (Caring, Original, Resilient and Egoless) values
- Position requires up to 20% travel including mandatory in person attendance at All Hands meetings typically held twice per year
Benefits
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
- Commitment to growing you professionally and providing access to resources to further your development
- Apogee offers regular all team, in-person meetings to build relationships and problem solve
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• Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan • Support the design of trials and develop protocols and other relevant documents for individual studies • Support start-up activities related to assigned studies • Oversee day-to-day clinical and medical execution of studies • Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan • Partner with clinical operations on site selection, recruitment, and CRO management • Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards • Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable
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Principal Medical Science Liaison - Smart Infusion Pumps
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JOB RESPONSIBILITIES: - Lead clinical program strategy - Define and refine clinical development plans from FIH through proof‑of‑concept and into pivotal planning - Contribute to target product profiles, indication sequencing, and lifecycle strategy across cardiometabolic and related franchises - Integrate nonclinical, translational, and clinical data to inform dose selection, patient population, and endpoint strategy - Own medical leadership for key studies - Serve as global medical lead for assigned studies/programs, providing medical and scientific leadership to cross‑functional teams - Lead the design of Phase 1–2 trials (and contribute to Phase 3 planning), including objectives, endpoints, inclusion/exclusion criteria, and risk–benefit considerations - Chair or co‑chair safety review / dose‑escalation committees, ensuring timely, balanced dose decisions grounded in safety and PK/PD data - Ensure high‑quality clinical and regulatory documentation - Lead or oversee authoring of clinical components of protocols, IBs, ICFs, CSRs, pediatric plans, and other key documents - Author clinical sections of regulatory submissions (e.g., IND/CTA, briefing packages, responses to health authorities) and participate in FDA/EMA and other agency interactions - Partner with Biostatistics, Clinical Pharmacology, and Translational Science on endpoint hierarchy, statistical analysis plans, and biomarker strategies - Provide ongoing medical oversight and safety leadership - Provide medical monitoring oversight, including review of eligibility, safety signals, and protocol deviations - Collaborate with Pharmacovigilance on safety evaluation, signal detection, and risk mitigation strategies - Lead or contribute to Safety Review Committees/Data Monitoring Committees, including review of safety narratives and serious adverse events - Drive data interpretation and communication - Lead integrated interpretation of efficacy, safety, PK/PD, and biomarker data for internal decision‑making and external communication - Prepare and deliver presentations to internal governance, board‑level committees as appropriate, and external stakeholders - Oversee or contribute to abstracts, posters, and manuscripts for major scientific and medical congresses and peer‑reviewed journals - Engage with investigators, KOLs, and external partners - Build and maintain strong relationships with investigators and KOLs in cardiometabolic medicine and related fields - Lead or co‑lead advisory boards and scientific consultations, ensuring external insights are incorporated into program strategy and study design - Collaborate with CROs and other vendors to ensure alignment on medical/scientific expectations and quality - Mentor and build the clinical organization - Provide coaching and guidance to Clinical Scientists, Medical Monitors, and Clinical Operations colleagues - Help shape clinical development best practices, templates, and processes across the portfolio - Model a culture of scientific rigor, transparency, and cross‑functional collaboration QUALIFICATIONS: - Education and clinical training - o MD or equivalent medical degree required - o Board certification in Internal Medicine with subspecialty training in Endocrinology, Cardiology, or related cardiometabolic field strongly preferred - o Active or eligible medical licensure in at least one jurisdiction - Industry and clinical development experience - o Typically 7–10+ years of experience in biotech/pharma clinical development, with increasing responsibility; 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