RETAINED SEARCH: VP, Head of Drug Safety : Global Oncology Biopharma (Boston) | Build Function From Scratch
Our client is a stable, well-funded, and growing Global Biopharmaceutical Company in the Boston area that is focused in Oncology and has multiple assets in Phase II and III development. This is a newly created senior-leadership role responsible for building/growing the leadership and management of all aspects within Drug Safety, Pharmacovigilance and Risk Management. You will be responsible for medical leadership, operations, risk management, signal detection, people management, cross-functional management, executive-level collaboration, strategy, vendor relationships, compliance, budgets/resources, regulatory authority interaction, systems management, etc.
Our client offers a “best of both worlds” value proposition – It is a well-financed (by its parent company) and has multiple assets in Phases I-III, but maintains an agile “start-up” culture where decisions are made quickly and there is a collegial environment. Our client also has historically offered favorable compensation/relocation packages, which will enable you to attract top talent to your department.
Attractive features about this opportunity:
Newly-Created, Impactful Role: This is a newly created, impactful role in which you will have the opportunity to architect, build, and lead the Company’s first centralized Drug Safety, PV & RM department. Heretofore, Drug Safety has been handled by the Clinical Leads, but now the Company is looking for someone to build a centralized function, which would be a welcome development by the Clinical Leads.
Science/Pipeline: Company is considered a major leader on the R&D forefront within their particular area of focus. This includes multiple later stage programs.
CEO’s Track Record: The CEO has a strong track record of success in both Biotech and “Big Pharma”.
“Best of Both Worlds” (Biotech culture combined with stability and resources): Our client’s parent company supports the organization with the resources and advantages not usually available to a biotech. Furthermore, our client never has to look externally for further investment, offering a great deal of stability, and allowing them to focus on developing their pre-clinical and clinical pipelines.
Location: Boston/Cambridge, Massachusetts area. Our client can offer a competitive relocation package.
Scope of responsibilities:
- Ownership/accountability for all Drug Safety, Pharmacovigilance and Risk Management activities across Clinical Development and future Commercialization.
- Build from scratch a dedicated team of Drug Safety/PV professionals to include Physicians, Operations, etc.
- Develop policies, SOPs, timelines, budgets, etc.
- Lead/implement signal detection and risk management activities.
- Lead/direct all safety related regulatory interactions, serving as the key communicator to external parties regarding safety issues for all clinical development programs and future commercial products.
- Monitor and assess all safety issues across all development programs ensuring that all safety related activities comply with applicable local standards and pharmacovigilance exchange agreements with partners.
- Ensure timely and accurate submission of all safety reports to regulatory authorities in compliance with safety reporting standards.
- Oversee the implementation and maintenance of global safety database and report generating systems to support timely safety reporting to FDA and global regulatory agencies.
- Represent the Company at medical/scientific meetings and congresses pertaining to areas related to Drug Safety.
- M.D. degree with ideally 7+ years of focused drug safety experience.
- Oncology experience is a plus, but not required.
- Direct report experience.
- Highly developed industry acumen with an ability to formulate complex strategies, operational plans and change strategies that address the interests and needs of the Company.
- Proven ability to investigate and resolve complex safety related issues, and make/evaluate proposals for appropriate corrective action.
- Strong understanding of global drug safety dynamics.
- Direct experience interacting with the FDA as well as ideally with global health agencies and authorities.
- Positive reputation with the FDA (and ideally other international regulatory bodies) as well as with peers, investigators, etc.
- Demonstrated ability to align people, policies, and processes to foster a collaborative environment and to sustain collaboration through the continual communication of group mission and team based outcomes.
Thomas Fascia, Partner
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