Hybrid Associate Medical Director, Safety Evaluation – Risk Management, Neuromuscular

at Asklepios BioPharmaceutical, Inc. (AskBio)

• Job title: Associate Medical Director, Safety Evaluation – Risk Management, Neuromuscular
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Durham, United States

About the role

• Associate Medical Director responsible for strategic medical leadership in Clinical Safety and Risk Management. Working with cross-functional teams in a hybrid environment for investigational products.

Responsibilities

• Represent Medical Safety & Pharmacovigilance in Clinical Teams for assigned investigational products providing medical guidance in planning and gaining alignment for all safety matters and issues
• Lead Safety Management Team(s) navigating complex safety issues for assigned Investigational product(s) and responsible for all associated risk management activities, including regular review of safety data for identification and evaluation of new safety signals
• Provide safety review and safety content for critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs/IDMC Charters
• Provides/oversees medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database
• Provide input in responding to and resolving safety questions from regulatory authorities
• Provide input/oversee production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide

Requirements

• Advanced medical degree (e.g., MD, MBBS, DO) and 3+ years of relevant experience in Safety Risk Management, Clinical Safety, or Pharmacovigilance
• Good working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines
• Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics
• Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
• Excellent written and spoken English

Benefits

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