Sr Director, Medical & Safety
700 Technology Square, Flr 2 Cambridge, MA 02139 US
Job Description
Position Overview:
Essential Duties and Responsibilities:
- Broad remit across risk management, signal detection and periodic reporting consistent with relevant regulations, legislation and guidelines
- Leads internal safety meetings and ensures prompt response to requests for further information or queries received from Regulatory Agencies
- Maintains and optimizes PV procedures, including vendor oversight, compliance and quality checks
- Contributes to the preparation of PV related documents [DSUR, SMP, CCDS, IB, ICF) for internal and external purposes
- Participates in audits and inspections and contributes to the development of corrective and preventative actions, as necessary
- Contributes to briefing packages for regulatory meetings and responses to questions and participates in Regulatory meetings
- Provides input on clinical trial strategy and contributes to the development of clinical protocols and associated documents
- Provides medical monitoring activities including responding to medical questions from clinical trial sites and participating in investigator meetings, site initiation visits and safety committees
- Participates in medical and safety review of study specific and aggregated data in ongoing trials, e.g., safety and statistical outputs
- Supports development of Clinical Study Reports (CSRs)
- Supports Med Affairs in KOL management, preparation of publications and advisory boards
Educational Qualifications:
- Medical Degree, board certification or equivalent preferred
- Experience in both, pharmacovigilance and medical monitoring preferred
- At least 5 years of experience in the biotech or pharmaceutical industry with experience working with cross-functional teams
- Broad clinical expertise preferred
Additional Qualifications:
- Excellent interpersonal and communication skills (verbal and written) for interactions across functional areas and with external parties
- Collaborative, proactive and hands-on approach
- Good attention to detail and strong analytical skills
- Willingness to establish, manage and supervise processes as needed with the necessary authority while also allowing for flexibility where appropriate
- Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment
- Scientific curiosity and willingness to learn and understand
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