Director, Medical Safety and Risk Management in Cambridge

The Director, Medical Safety and Risk Management leads the development and maintenance of the safety profile of assigned products throughout the entire lifecycle of a product. This is a highly visible role that interfaces across all levels and functional areas and partners closely with the clinical development, regulatory, and commercial teams. The exceptional candidate that we seek will have an excellent medical judgment, strong analytical skills, proactive approach in drug safety and a flexible, hands-on nature with a high sense of urgency.

Summary of Key Responsibilities

• Lead strategic development of the safety profile of assigned products.
• Lead active monitoring and continued assessment of safety data through systematic signal detection and critical review of aggregate safety data and literature during all phases of the lifecycle of a defined portfolio of products.
• Guide the clinical development teams regarding all aspects of clinical safety, including trial design, appropriateness of safety endpoints, analysis and interpretation of safety data.
• Be accountable for timely completion of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.
• Lead multidisciplinary teams regarding safety relevant topics and escalate all relevant safety matters to the appropriate decision-making level with proposals for solutions based on analysis of the available information.
• Serve as the safety expert providing strategic input to key stakeholders in relation to product safety, understand the business strategy for the product and be knowledgeable about the medical context of the respective product class.
• Be the subject matter expert for relevant safety discussions with regulatory agencies and other significant external bodies.
• Be the author and accountable content owner for all safety relevant content or documents during clinical development and post approval.
• Be content owner for safety relevant communications such as DHCP letters and company statements.
• Collaborate with pharmacovigilance and drug safety colleagues from licensing partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.

Qualifications

• Medical Degree with a minimum of 3 years of medical practice is required.
• Sound clinical acumen and a wide range of therapeutic area knowledge.
• Pharmaceutical industry experience in pharmacovigilance and/or clinical research/development is preferred.
• Experience in clinical development is a plus.
• Knowledge of clinical research methodology, clinical epidemiology/biostatistics, pharmacovigilance tools and processes and relevant regulatory framework.
• Ability to synthesize and analyze safety data from various sources.
• Proficiency in problem-solving within a highly complex environment.
• Strong communications skills, both written and spoken, ideally with demonstrable experience in medical/scientific writing.
• Excellent networking and relationship building skills for successful cooperation with internal and external customers.
• Expertise in international regulations governing drug safety.
• Experience in managing compliance or audits.
• Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred.
• Excellent interpersonal and decision-making skills.
• Strong influencing skills with the ability to quickly earn credibility across other functional areas.
• Ability to work in fast-paced environment with rapidly approaching timelines is important.