Executive Director, Drug Safety & Pharmacovigilance

Edgewise Therapeutics•Boulder, CO

16d•$275,000 - $350,000•Onsite

About The Position

The Executive Director, Drug Safety & Pharmacovigilance will oversee all safety and benefit-risk related activities and Aggregate Report Risk Management within the Edgewise Therapeutics Drug Safety & Pharmacovigilance Department. As a member of the Drug Safety & Pharmacovigilance Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s). Overseeing and ensure consistent conduct and timely execution of Benefit-Risk activities including pre-marketing risk assessment, planning for First-In-Human (FIH) studies and additional clinical studies in various phases of development, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables.

Requirements

MD, DO or Equivalent with at least 15 years of experience in Pharmaceutical Industry/Biotech and at least 10 years in drug safety and pharmacovigilance.
Extensive knowledge of GCP, GVP, ICH and Global regulations.
In-depth and comprehensive knowledge of General Medicine.
Strong leadership skills with the ability to communicate effectively in a matrix environment.
Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging.
Extensive knowledge of Benefit-Risk strategies and decision-making.
Ability to multi-task, adeptly handling multiple demands.
Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.

Responsibilities

Provides leadership and oversight for all products across the Edgewise Portfolio, including key benefit-risk assessment, and providing strategies for safety & pharmacovigilance to meet corporate and department goals and objectives.
Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Edgewise signal detection practices.
Collaborates with Clinical team/Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed.
Collaborates with NDA teams' assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents.
Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs.
Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable.
Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.
Provides and oversees medical reviews of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with Global Drug Safety & Pharmacovigilance review practices.
Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources.
Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter.
Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
Reviews and provides oversight of safety sections of clinical study reports.
Provides a contributory role in Partner /Affiliate agreements and interactions, as needed.
Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.
Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
Facilitates the growth and development of staff and direct reports.
Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
Perform other duties as assigned by supervisor.