Head, Global Drug Safety & PV (report to CMO) | well-funded Oncology Biotech | 5+ clinical-stage assets | New Jersey: RETAINED SEARCH
Summary: Cornerstone Search Group has been retained by a highly/uniquely attractive Oncology/I-O biotech for a newly-created Head of Global Drug Safety & Pharmacovigilance position reporting to the CMO. This is a “best-of-both-worlds” opportunity because you will simultaneously enjoy the benefits of a smaller, entrepreneurial environment while having the comfort and security of working for a well-funded public company with a large, diverse, internally-created pipeline. Furthermore, our client has multiple strategic relationships/collaborations with top pharma companies.
As compared to many Drug Safety & PV roles in mid-size and larger companies, this opportunity immediately cuts through the "red tape" and gives you the ability to be directly responsible for their Drug Safety/Pharmacovigilance success and interact at the highest levels of the organization. You will serve as the Safety/PV leader by creating the company’s first global group. They are looking for a qualified candidate that can develop strategy, work cross-functionally, build a team and also remain a hands-on influence to the department.
Location: North/Central New Jersey. Commutable from various locations in NJ, PA, NY & NYC. Partial work@home will be considered for those who live far away or can’t permanently relocate to the area.
Relocation Benefits: Our client will 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/or combination therapies.
- Company Stability & Growth: Our client is positioned to operate in a lean and creative manner, while also maintaining a very stable and strong growth position.
- Very Strong Funding: This publicly-traded biotech has very strong cash reserves to support the development of their large and diverse pipeline of mono- and combination therapies.
- Share in the Company’s Success: This company’s pipeline is in a position to potentially yield multiple products submissions over the next 2-4 years. This is an opportunity to share in the success of a company at a critical stage in its growth cycle.
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
- Improve the consistency and accuracy of medical assessments
- Manage the Medical Drug Safety team and identify the system and resource needs to ensure quality and compliant medical safety evaluation processes
- Lead the development and maintenance of 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 and consistently represented in relevant labeling documents, identify and lead updates as required
- Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory (including IND and NDA) submission documents
- Oversee the development of relevant medical sections of responses to safety related health authority requests, various clinical documents including 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 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 or equivalent (i.e. MBBS, DO, etc.) required
- Industry experience in Oncology is required
- Clinical-stage drug safety & PV experience is required
- Regulatory authority interaction experience, preferably in both US and ex-US
- NDA/BLA submission experience is a plus
- Prior experience overseeing a slate of compounds is a plus
- Ability to lead and manage people
Lavinia C. Rodriguez | Director
P 973-656-0220 x740
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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