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
Leap Therapeutics is seeking motivated individuals with drug safety/pharmacovigilance experience to be part of a growing oncology company. Successful candidates will work within a highly collaborative team environment to assist in developing and implementing operational plans designed to meet project timelines and the company’s business objectives
Reporting to the Head of Pharmacovigilance, the Director of PV Operations role will lead and support pharmacovigilance and risk management activities for Leap clinical development programs in compliance with regulatory guidelines. This individual will support the development and implementation of signal management through contributions to clinical deliverables and activities.
Specific responsibilities include:
• Conducts all tasks in accordance with applicable Company Policies, Guidelines, Quality Documents, Standard Operating Procedures (SOPs), Working Instructions (Wis), and other Guidance and Standards, as well as current Good Clinical Practice (ICH-GCP) and applicable national regulations
• Support the overseeing of PV/safety vendors
• Support PV intake processes globally including but not limited to interfaces and shared processes with PV Clinical Development, Regulatory Affairs, Quality Assurance, Legal, etc.
• Oversee and support PV intake mailboxes and communications of Individual Case Safety Reports (ICSRs).
• Support PV’s process for PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) including direct discussions with vendors/partners, creation, and maintenance of the agreements.
• Support and oversee PV safety data reconciliations.
• Support PV process for safety-related medical inquiries.
• Support inspection readiness activities and participate in regulatory inspections.
• Support the Head of Pharmacovigilance and Quality Management with developing and implementing appropriate PV processes and systems.
• Ensure PV central and site file documentation is appropriately tracked and filed, e.g. TMF. Ensure that documentation complies with ICH/GCP and project specific requirements.
• Reconcile and inventory PV study documentation periodically and for archiving at study close-out.
• Supports PV activities including taking meeting minutes/providing agendas to the clinical team, tracking PV study trackers.
• The Director of PV Operations is responsible for supporting the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs) pooling scientific literature for safety information, and supporting Clinical Trial PV medical activities.
• The Director of PV Operations also support cross-functional teams on safety regulations and guidelines; data output and analyses; and product specific information. In this capacity, the role is critical supporting products in clinical trials and continue to maintain good standing with countries where studies are ongoing to ensure PV quality surveillance.
• Administratively support the signal management process (ie, signal detection, signal tracking, signal documentation, facilitating meetings decisions regarding signals and safety risk, etc.) for assigned product. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
• Collaborates with Head of PV and other Clinical MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.
• Support the ad hoc safety questions by internal and external stakeholders.
• Support and participate in Safety Review Team meetings
• Perform other PV tasks as needed and requested by the Head of PV and the Chief Medical Officer.
Education / Experience / Skills:
• Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required.
• Master’s or Doctorate level degree in health care related profession preferred, but not essential.
• Minimum of 5-7 years of experience in drug safety/pharmacovigilance in a pharmaceutical industry setting or the equivalent. Small biotech experience is preferred, but not essential.
• Global pharmacovigilance PV Operations experience with products in development and post market. PV Scientist experience is a plus.
• Safety signal detection and aggregate reporting experience.
• Knowledge of FDA and EU regulations and ICH guidelines.
• Strong analytical and problem-solving skills with attention to both strategy and detail.
• Strong verbal, written technical communication and presentation skills.
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within the organization.
• Proven ability to work within a cross-functional team.
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.