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Sr. Director/ VP, Head, Pharmacovigilance

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Company Summary:

Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. Leap has a strong financial position and in September 2021 closed a public offering with gross proceeds to Leap of approximately $104 million. Leap is based in Cambridge, MA. For more information about Leap Therapeutics, visit http://www.leaptx.com.

 

General Responsibilities:

• Develop overall risk management plans, pharmacovigilance strategies, risk minimizations activities, and contribute to the assessment of risk/benefit for Leap products
• Manage interactions with Safety Review Committees in relevant studies, providing input and collaboration regarding IDMC charter
• Oversee, prepare, and review scheduled related periodic/annual reports per FDA, MHRA, EMA, and other applicable regulatory authorities’ regulations
• Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business to review and provide input to protocols, investigators brochures (IBs), clinical safety reports (CSRs), Informed Consent Forms (ICFs) and other safety-related documents
• Support interactions and report, respond and resolve safety questions from the FDA, EMEA, and other regulatory authorities, and respond to regulatory agency audits
• Recognize and escalate significant issues relating to compliance, budgets, timelines, or other issues that may jeopardize business objectives
• Develop and maintain SOPs as needed and ensure compliance by providing training in Pharmacovigilance across the Company.
• Management and approval of budgets/contracts
• Have talent management and professional development responsibilities for key personnel in the PV functional area
• Working closely with the Pharmacovigilance service provider, as applicable, overseeing all related outsourced activities
• Conducting all Pharmacovigilance activities for medicinal products, including medical assessment, ongoing safety evaluation and signal detection
• Performing medical evaluation/review of individual case safety reports as per applicable SOPs (Standard Operating Procedures), safety product/project plans, regulatory reporting timelines and in collaboration with external service providers
• Reviewing Individual Case Study Reports (ICSRs) (e.g., completing narratives, verifying MedDRA coding, writing medical assessments) in collaboration with CROs, as applicable
• Drafting response to safety-related requests from Health Authorities in collaboration with the CMO
• Supporting Health Authority Inspections and audits, particularly those with a focus on Pharmacovigilance
• Overseeing the performance of licensed partners or contracted service providers regarding drug safety activities

 

Specific Responsibilities Include:
• Leading the Safety Review team, the ongoing and proactive monitoring of the safety profile of Leap medicinal products to ensure the identification and evaluation of potential risks associated with medicinal products and that appropriate actions are taken to ensure patient safety
• Drafting and reviewing Pharmacovigilance processes: Policies, SOPs, templates, forms, and plans as well as Safety Data Exchange Agreements (SDEAs) with partner companies, as applicable
• Recommending changes of the (Development) Core Safety Information / Reference Safety Information, as appropriate, and communicating identified risks to applicable internal and external stakeholders, as appropriate
• Overseeing, preparing, coordinating, and assisting in the preparation and review of key pharmacovigilance documents such as Drug Safety Update Reports (DSURs), Development Core Safety Information (DCSI), Risk Management Plans, and safety sections of Investigator Brochures (IBs), Informed Consent Forms (ICFs) and clinical trial/study protocols and final reports in accordance with legal requirements, respective SOPs and Health Authority expectations
• Performing training of company personnel, CROs and investigational site personnel regarding Pharmacovigilance, as appropriate
• Maintaining up-to-date knowledge of the drug safety environment to identify pharmacovigilance process gaps and deficiencies

Education / Experience / Skills:
• M.D. degree required
• Minimum of 10 years of pharmacovigilance experience with at least 8 years managing medical case review and signal detection in a biotech/pharmaceutical setting
• Thorough knowledge of FDA and ICH guidelines
• Proven experience working with within a cross-functional team environment
• Knowledge of MedDRA terminology and its application
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Ability to assimilate clinical data and through comprehensive analysis/review and able to make assessments
• Ability to work in a fast-paced and collaborative environment
• Strong written, verbal, technical and presentation skills

 

Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.