We are seeking a highly motivated individual to join us as a Director, Patient Safety. You will work with the Clinical Development team in supporting our efforts in this exciting new area of cancer immunotherapy.
Responsibilities (include but are not limited to):
- Medical safety expert for product candidates
- Oversight of clinical trial safety including safety monitoring plan and data analysis
- Assess emerging safety data, ensure appropriate risk communication, and development of risk management/minimization strategies
- Respond to queries relevant to the safety of products from the agencies and other internal functions
- Provide review of clinical protocols and study reports to ensure alignment with Clinical development plans and safety being adequately addressed.
- Carry out medical review of Serious Adverse Event reports from clinical trials.
- Contributes to the safety section of the Investigators Brochure (IB)
- Contribute to regulatory authority submissions (e.g. NDAs,) by reviewing safety data and preparing relevant sections of the submission
- Aggregate safety reports, safety aspects of regulatory filings
- MD or equivalent degree; completion of residency
- 3- 5 years of industry experience in safety and pharmacovigilance; oncology experience required
- Global experience in clinical trial as well as post-marketing setting
- Global regulatory filings
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Good knowledge of US and EU pharmacovigilance regulatory requirements
- Ability to function in a matrix organization
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities