Vice President, Pharmacovigilance - Cambridge, United States - Nuvalent Inc.

Description

The Company:

With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer.

Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role:

Reporting to the Chief Medical Officer, the Vice President, Pharmacovigilance and Safety will lead and build the Pharmacovigilance function, building best practice, scalable processes and initiatives.

The role will be a key member of the R&D team owning the clinical safety strategy. The incumbent will lead and grow the PV team and collaborate across a cross-functional environment.

As the face of PV/Safety, the subject matter expert and will build relationships and collaborate with internal stakeholders, consultants, external partners, and Health Authorities, ensuring compliance, and providing leadership and oversight throughout the product development lifecycle.

This position requires a strong clinical background and expertise in pharmacovigilance in all stages of development, including post-marketing, with prior experience focused in oncology therapeutics.

The successful candidate will drive, promote and embed a culture of ethics, integrity, collaboration and continuous improvement.

The VP of Pharmacovigilance is responsible for all PV/Safety-related activities of Nuvalent products throughout the product lifecycle.

The incumbent is accountable for the development, implementation, and maintenance of corporate policies, procedures and practices ensuring the safety of our products in development and in time, will develop and maintain the post-marketing PV system.

The person in this position will work closely with the CMO, and the Safety and Clinical Development Teams providing input to the monitoring activities and assessment of the safety profile for all Nuvalent products.

Leading all aspects of PV operations, including vendor oversight is a key responsibility of this position.

This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and best practice, scalable, standard operating procedures (SOPs).

Responsibilities:

• Grow, direct, and support products from initial IND/CTA, through NDA/ MAA filings, to approval and post-marketing.
• Oversee Safety Operations; establish and maintain policies and procedures for the Clinical Drug Safety Department to maintain worldwide regulatory compliance.
• Provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
• Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources of potential product signals.
• Responsible for governance and oversight of CROs and ICSR case processing and worldwide reporting and Safety Database activities.
• Lead transition to post-marketing PV, in conjunction with ongoing robust clinical development program of existing and new molecules.
• Lead process improvement within global pharmacovigilance - including technology assessment and implementation.
• Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.
• Provide medical input/review of new or existing safety documents to ensure compliance with relevant regulatory requirements, including protocols, informed consent documents, safety summaries and regulatory reports.
• Manage PV aspects of compliance documents and other deliverables (all regulatory submissions [NDA/MAA safety sections and CCDS/RMP, PSUR, DSUR, PBRER], original articles, abstracts), and presentation materials.
• Lead all PV activities related to audit and inspection readiness. Active participation in inspection/audit preparedness activities, serving as subject matter expert during regulatory inspections in a cross-functional collaboration with team members.
• Act as PV lead for labeling activities, including development of the company core data sheet.

Competencies

• Excellent communications skills (verbal, written, presentation, etc.) -the ability to articulate, influence, and work successfully with varied audiences (colleagues, external partners, etc.)
• Adjusts easily to change, learns quickly, and understands how internal and external factors impact decisions.
• Demonstrated ability to understand needs and align stakeholders, influence decisions and develop roadmaps and project plans to meet business needs.
• Ability to work productively and build relationships in a fast-paced, results-driven, highly accountable environment where you can demonstrate initiative and make a clear impact.
• Proven ability and history of establishing and maintaining strong alliance relationships, including boards, senior leaders and external audiences.
• Experience mentoring all levels to further develop skills, provide opportunities for growth, and ensure a professionally challenging environment that fosters success.

Qualifications:

• Residency trained physician (MD) strongly preferred but will consider candidates with other clinical degrees providing they have a proven record of safety/pharmacovigilance leadership.
• Minimum of 15 years of Biopharma, CRO or Regulatory Agency experience in Safety and Pharmacovigilance.
• Experience in creating development and post-marketing systems and processes for handling, analysis, and regulatory reporting of adverse event reports events.
• Experience leading drug safety through all phases of drug development from pre-IND to Phase 4, and with exposure to significant drug development safety issues, including 'clinical holds' and product recalls / withdrawals, and safety-related label changes.
• Expertise in risk/benefit evaluation, signal detection, aggregate reports, and safety evaluations.
• Experience in vendor oversight, including developing governance charters and leading governance meetings.
• Robust knowledge of MedDRA dictionary with relevance to SAE analysis and SAE.
• Familiarity with common safety databases (e.g., Aris, AERS, Argus, etc.) preferred.
• Direct experience of regulatory interactions such as pre-IND, EOP2, Ad Comm meetings, and label negotiations.

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies.

Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a "no-" email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email.

Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at Thank you.