Executive Medical Director, Drug Safety & PV – reports to CMO of public Oncology Biotech | New Jersey: RETAINED SEARCH
Summary: Cornerstone Search Group’s Medical Director Practice has been retained by uniquely attractive Oncology biotech for an Executive Director position that reports to the CMO and will be responsible for building and leading Drug Safety & Pharmacovigilance. This is a “best-of-both-worlds” opportunity because you will simultaneously enjoy the benefits of a smaller, entrepreneurial environment while having the security of working for a well-funded, publicly traded company with a large, internally discovered Oncology pipeline. Furthermore, our client has multiple strategic relationships/collaborations in place with top pharma companies.
Our client is seeking a drug safety physician with clinical stage, pharma/biotech Oncology experience with at least 7 years of experience. They will consider a current Director or Sr. Director who is ready to take the next step in his/her career by developing a global drug safety & PV function, hiring a team of MDs and non-MDs, developing global drug safety & PV strategy, and working well cross-functionally with other function area leadership, the CMO, CSO and CEO.
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 or can’t permanently relocate to the area.
Relocation Benefits: Our client can provide relocation assistance.
Attractive features about this position and company:
- High Visibility: You will report directly to a very accomplished CMO and have regular interaction with the highest levels of the organization.
- Diverse and Attractive Pipeline: 5+ compounds in clinical stage (I-III) development for various liquid and solid tumor indications being studied as mono and combination therapies.
- Company Stability: All compounds have been discovered internally and senior management has been very stable.
- Very Strong Funding: This publicly traded biotech has very strong cash reserves to support the development of their large and diverse pipeline.
- Share in the Company’s Success: This company’s pipeline is in a position to yield potentially multiple product submissions over the next 2-4 years. This is an opportunity to share in the success of a publicly traded company at a critical stage in its growth cycle as the company has generous long-term incentives (both stock options and RSUs).
- Career-building Opportunity: Our client is open to considering bright, driven, and accomplished Directors and Sr. Directors who are hungry to take the next step in their career by taking on a strategic leadership position and building a function and a team.
Responsibilities: Challenges, Expectations and Deliverables for this position:
- Lead the development of pharmacovigilance strategies for monitoring the safety profile of products.
- Responsible for detection and benefit/risk management activities.
- Build and manage a Medical Drug Safety team and identify the system and resource needs for a high-functioning medical safety evaluation processes.
- Lead the development of both general 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 represented in the relevant labeling documents.
- Lead the preparation of safety information for regulatory (including IND and NDA/BLA) submission documents.
- Oversee the development of the relevant medical sections of responses to safety related health authority requests as well as for clinical documents such as Investigators Brochures, 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.
- Oversee medical review of ICSRs.
- Identify opportunities and manage continuous improvement initiatives as related to the medical assessment of pharmacovigilance data.
Experiences, Skills, Accomplishments and Qualities Desired:
- MD or equivalent (i.e. MBBS, DO, etc.) required.
- Pharma/biotech industry experience in clinical-stage Oncology Drug Safety/PV is required.
- FDA regulatory authority interaction experience, with ex-US reg authority experience a plus.
- NDA/BLA submission experience is a plus.
- Ability to lead and manage people. Experience managing other Drug Safety MDs is a plus, but not required for consideration.
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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