Apogee Therapeutics
Biotechnology
MedicalDirector,Pharmacovigilance
Neural analysis suggests this role is
optimal for Director candidates.
“Medical Director, Pharmacovigilance at Apogee Therapeutics. Skills: Pharmacovigilance, Drug safety, Regulatory affairs. Identify emerging safety signals. Ensure appropriate escalation”
Industry & Context.
Up to 20% travel, Mandatory in person attendance
What They're Looking For.
Must Have
MD degree required, 8 years pharmacovigilance experience, Global regulatory requirements expertise
Nice to Have
Exposure to biologics, I&I conditions experience, Dermatology indications experience, Respiratory indications experience, Late-stage development experience, Submissions experience
What You'll Do.
Identify emerging safety signals
Ensure appropriate escalation
Contribute to pharmacovigilance strategies
Maintain benefit-risk assessments
Collaborate with Regulatory Affairs
Develop responses to inquiries
Ensure high-quality MedDRA coding
Ensure appropriate event characterization
Ensure robust safety narratives
Lead preparation of DSURs
Lead preparation of IBs
Lead preparation of safety sections
Lead review of safety sections
Provide safety input to submissions
Provide safety input to protocol amendments
Provide safety input to health authority inquiries
Partner with Regulatory Affairs
Partner with Quality teams
Address safety findings
Address corrective actions
Collaborate with Clinical Development
Collaborate with Regulatory Affairs
Collaborate with Medical Affairs
Collaborate with Biostatistics
Collaborate with Data Management
Collaborate with Medical Writing
Support development of ISS
Support safety components of NDAs
Support safety components of BLAs
Support safety components of MAAs
Review safety content of publications
Review safety content of posters
Review safety content of abstracts
Review safety content of manuscripts
How You'll Work.
Team & Collaboration
Regulatory Affairs; Quality teams; Clinical Development; Medical Affairs; Biostatistics; Data Management; Medical Writing
Full Job Description
About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R. E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! Role Summary We are seeking a Medical Director, Pharmacovigilance to join the Apogee Clinical Development team. In this newly created position, you will be responsible for safety aspects across Apogee’s pipeline. This role is critical in supporting regulatory approvals, patient safety, and long-term safety input into life-cycle management. Additionally, you will play a key role in supporting drug safety and pharmacovigilance activities
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