Our client is a clinical-stage biopharmaceutical company developing novel cell therapies for cancer. They have asked us to assist them in their search for a Vice President and Head of Clinical Safety and Pharmacovigilance.

Reporting to the Chief Medical Officer, this role leads the strategic and operational management, planning, and execution of clinical safety, pharmacovigilance, and risk management for early and late-stage clinical development programs in compliance with the appropriate regulatory guidelines.

 Major tasks and responsibilities include:

• Organizes and oversees product safety surveillance and evolving safety profiles for products in clinical development as well as marketed products.
• Contribute to the Company’s overall clinical development strategy as a member of the Chief Medical Officer’s leadership team.
• Collaborates with all areas of Clinical, Quantitative & Decision Sciences, Regulatory, CMC, Commercial, Clinical Research internally, as well as site investigators, contract research organizations (CROs) and drug development collaborators/partners to ensure that clinical safety and pharmacovigilance are implemented effectively and strategically across all planned and ongoing clinical trials.
• Reviews and approves drug safety information from clinical sources in accordance with WHO-ICH guidelines and the appropriate regulatory agencies, including FDA.
• Identifies and analyzes safety signals emerging from individual or aggregate safety event analyses: performing analyses of specific events across studies, as indicated.
• Develops and implements SOPs and other controlled documents to support investigational and ultimately, marketed product safety surveillance.
• Oversees investigational and/or approved drug safety updates, SUSAR and investigational new drug, safety reports, investigator communications, Development Safety Update Reports (DSURs) and other reports as necessary.
• Participates on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, and other documents providing safety content.
• Liaises with Medical, Clinical Operations, Quantitative & Decision Sciences, Regulatory Affairs, Quality and Compliance to ensure appropriate and timely communication/dissemination of safety information to internal members and external stakeholders including publications and corporate documents.
• Leads the PV team; includes setting strategy and objectives, delegating and motivating, communicating regularly, career development planning, mentoring and guidance.
• Oversees development of Clinical Safety and Pharmacovigilance training programs for both internal and external use related to implementing, executing, and maintaining safety processes and systems.
• Monitors CRO performance to ensure optimal safety assessment and reporting of ongoing clinical trials.
• Leads team through pre-launch/launch efforts for company’s first commercialized product.

 
We seek candidates with the following qualifications:

• Must have a medical degree with relevant clinical experience, preferably in oncology, hematology, and/or immunology.
• Requires a minimum of 12 years combined in international pharmacovigilance/drug safety pharmaceutical industry and clinical medical practice experience.
• Previous leadership, management, and cross functional matrix experience required.
• Expert knowledge of international regulatory safety reporting requirements, including FDA/ICH guidance’s related to pharmacovigilance (e.g.E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety.
• Requires the ability to achieve compliant solutions to complex problems in which analysis of situations or data requires an in-depth, strategic evaluation of various factors.
• Must be a strong functional and matrix leader with demonstrated leadership skills and the ability to influence across external functions and within internal teams.
• Requires a high degree of flexibility and learning agility, and the ability to work in changing, fast-paced and sometimes ambiguous environments.
• Must be an excellent collaborator and team player with demonstrated high degree of emotional intelligence in working with others.
• Excellent, concise verbal and written communication skills are required.
• Effective presentation skills are required since this role will interact with governance bodies, the Executive Team and at times, the Board of Directors as well as external parties.
• Requires the ability and willingness to “roll up sleeves” to get work accomplished, in addition to being a big picture, strategic thinker.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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