RETAINED SEARCH: Executive Director, Head of Drug Safety : Global Oncology Biopharma (Boston)

Cornerstone Search Group Published: September 14, 2017
Category
Job Code
tfBH2608csg
Contact Email
tfascia@cornerstonesg.com

Description

RETAINED SEARCH: Executive Director, 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 leadership role (reporting to the CMO) 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.  Given their diverse pipeline/platforms and indications, this is a Biopharma with “multiple shots on goal.”  Their success or failure is not based on a single compound.

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 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.

Experience/Education:

  • 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.

Contact:

Thomas Fascia, Partner

tfascia@cornerstonesg.com - P 973-656-0220 x717

LinkedIn: https://www.linkedin.com/in/thomasfascia

CORNERSTONE SEARCH GROUP, LLC – www.cornerstonesg.com

Life Sciences Executive Search

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