Director Safety Physician

Responsibilities

• Contributes to clinical trial protocols
• Trains investigators
• Assesses safety data (e.g., adverse events of special interest and serious adverse events)
• Determines necessary follow-up actions
• Conducts safety signal detection and evaluation
• Ensures compliance with Good Clinical Practice (GCP) and regulatory reporting requirements
• Contributes to essential safety documents such as Development Safety Update Reports (DSURs), updates to reference safety information, Investigator Brochures, and Clinical Trial Reports
• Represents MSPv in Alliance management projects such as safety data exchange agreement negotiations; or joint oversight committees with development partners, and/or other collaborative development projects
• Serves as safety subject matter expert at the portfolio level and is the arbiter for safety-related issues in any of its constituting programs
• Ensures activities are performed in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standards
• Trains and mentors Safety Physicians and Safety Scientists

Qualifications

• Medical Degree (or internationally recognized equivalent)
• A MD/PhD and/or certified training in a relevant medical discipline is a plus
• Extensive drug safety/pharmacovigilance experience within the biopharmaceutical/biotechnology industry that includes the development of innovative drugs, BLA/MAA submissions, and advisory committee experience, preferably in immuno-oncology/inflammation therapeutic area(s)
• Exposure to, or direct experience in working with Regulatory Agencies on development strategies for innovative oncology products, particularly those of US
• Achieved demonstrable results in a matrix organization and in a multidisciplinary team, experience in implementing GCP standards in clinical trials, in particular safety reporting in compliance with global and local regulations

Benefits and Remuneration

Expected Pay Range: $168,100/year to $268,700/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).

Note: The availability, eligibility and design of the listed benefits may vary depending on the location.

How to Apply

To apply, please send your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.