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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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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