Sr. Director, Pharmacovigilance – Oncology – NJ Pharma: RETAINED SEARCH
Summary: Cornerstone Search Group’s Medical Director Practice is conducting a retained search for a New Jersey pharmaceutical company for their Senior Director, Drug Safety & Pharmacovigilance position which will lead their Oncology therapeutic area featuring a rich clinical pipeline. This position will have direct reports.
Our client is seeking a physician with Oncology, clinical-stage, pharma/biotech experience, with at least 3 years spent in drug safety/pharmacovigilance.
Location: New Jersey.
Our client is ideally situated in New Jersey within an hour of any town north of Princeton in New Jersey, Eastern Pennsylvania, Southern New York, and New York City. Partial work@home flexibility will be considered for those who live 1+ hours away and can’t permanently relocate to the area.
Relocation Benefits: Our client can provide relocation assistance.
Attractive features about this position and company:
- Direct Reports: This position will have other MDs and non-MDs reporting to it.
- Career-building Opportunity: Our client is open to considering bright, driven, and accomplished Director who has not had direct reports before. This position also covers both Drug Safety & Pharmacovigilance, so you will be working on NDA/BLA filings for the US and globally, developing safety strategies, interacting with the FDA/EMA/etc.
- Large Pipeline: They have a large pipeline of clinical stage (I-III) asset in development for various liquid and solid tumor indications being studied as mono and combination therapies.
- Company Stability: Senior management has been very stable and the company has an enviable track record of developing assets in-house.
Responsibilities: Challenges, Expectations and Deliverables for this position:
- Lead the development of PV strategies for monitoring the safety profile of products.
- Responsible for detection and benefit/risk management activities
- Manage a Medical Drug Safety team and identify the system and resources needed
- Develop safety signal management methodologies and product specific signaling strategies
- Lead aggregate safety data reviews and the preparation of the medical content, periodic reports (including PSURs, DSURs) and ad-hoc reports
- Ensure that the safety profiles of products are accurately and consistently represented in relevant labeling documents.
- Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents (including IND and NDA/BLA)
- Oversee the development of relevant medical sections of responses to safety related health authority requests as well as clinical documents such as IBs, clinical protocols, safety management plans, study reports, and integrated analyses
- Organize and conduct quarterly Medical Safety Board meetings to review aggregate safety information and signal management for all products
- Oversee medical review of individual case safety reports (ICSRs)
- Identify opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data
Experiences, Skills, Accomplishments and Qualities Desired:
- MD / MBBS / DO or the equivalent is required.
- Pharma/biotech industry experience with clinical-stage Oncology Drug Safety/PV is required.
- Direct report experience is a plus, but not required.
Corey S. Ackerman, JD | Senior Partner
P 973-656-0220 x716
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
Six Campus Drive | Parsippany, NJ 07054 USA
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Keywords: “patient safety"