Associate Medical Director, Safety Evaluation, Risk Management – Neuromuscular

Job not on LinkedIn

October 22

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Logo of Asklepios BioPharmaceutical, Inc. (AskBio)

Asklepios BioPharmaceutical, Inc. (AskBio)

Biotechnology • Pharmaceuticals • Healthcare Insurance

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading gene therapy company focused on developing treatments for debilitating genetic diseases. Wholly owned by Bayer AG, AskBio specializes in adeno-associated virus (AAV)-based gene therapies aimed at treating various neuromuscular, central nervous system, cardiovascular, and metabolic diseases. One of their notable developments is AB-1003 (LION-101), which has received FDA rare pediatric disease and orphan-drug designations for treating limb-girdle muscular dystrophy type 2I/R9. AskBio is dedicated to advancing genetic medicine, with a robust portfolio of clinical programs designed to bring innovative therapeutic options to patients worldwide.

501 - 1000 employees

Founded 2001

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Represent Medical Safety & Pharmacovigilance in Clinical Teams for assigned investigational products • Lead Safety Management Team(s) navigating complex safety issues for assigned Investigational product(s) • Provide safety review and safety content for critical development program documents • Provide input in responding to and resolving safety questions from regulatory authorities • Provide input/oversee production of regulatory periodic safety submissions

🎯 Requirements

• Advanced medical degree (e.g., MD, MBBS, DO) • 3+ years of relevant experience in Safety Risk Management, Clinical Safety, or Pharmacovigilance • Good working knowledge of global PV requirements • Strong interpersonal skills that facilitate collaboration across functions • Demonstrates excellent scientific/clinical and analytical knowledge base • Excellent written and spoken English

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities

Apply Now

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