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 being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, please visit http://www.leaptx.com.
General Responsibilities:
Reporting to the Head of Pharmacovigilance (PV), the Senior Director of PV Operations role will have direct oversight of vendor(s) conducting PV operational activities and play a key role in the overall safety operational strategy and safety reporting for all Leap products. This individual will lead and support PV and risk management activities for Leap clinical development programs in compliance with regulatory guidelines. Additionally, this individual will support the development and implementation of signal management through contributions to clinical deliverables and activities.
Specific Responsibilities Include:
Drives strategic planning, implementation, and management of DSPV Operations activities.
Responsible for managing internal and external staff allocated to operational PV activities, interacting with project teams across different resources.
Provides expert guidance and leadership based on in-depth knowledge of safety requirements, per ICH, local and global regulations and guidelines, and Good Pharmacovigilance Practice (GVP).
Provide vendor oversight and management for all outsourced and/or insourced PV activities, ensuring aggregate safety reporting and adverse event information is processed according to company timelines and quality standard.
Ensures that the DSPV database supports the department's needs, including specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant PV vendor.
Oversee the set-up of any new safety projects, including the development of study-specific Safety Management Plans and set up of safety systems and database configurations to accommodate these trials and products.
Contributes to strategy and development of department SOPs and work instructions related to the DSPV activities.
Continues to develop, enhance, and implement a DSPV inspection readiness program with the contribution of other PV and non-PV stakeholders.
Support signal management activities, including signal investigations and drafting signaling reports in collaboration with the Head of PV.
Collaborate on aggregate safety reports including project management, data requests, data analysis, data interpretation, narrative writing, and quality checks.
Support SAE reconciliation activities on assigned clinical studies.
Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs) and DSPV agreements with partners, vendors, and other third parties.
Collaborate with the Head of PV and contribute to responses from Regulatory Authorities, particularly safety requests.
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.
Effectively collaborates with key stakeholders at all levels in the organization. including Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Regulatory Affairs, Medical Affairs, and Business Partners to develop compliant procedures in line with industry standards and best practices
Represents DSPV on project teams and committees, as needed.
Responsible for ensuring high-quality individual case safety reports are prepared and submitted by contracted vendor responsible for these activities.
Ensure compliance of the Safety System in accordance with global regulatory requirements.
Oversee and support PV intake mailboxes and communications of Individual Case Safety Reports (ICSRs).
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.
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.
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.
Collaborates administratively 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
Education / Experience / Skills:
Bachelors/Advanced degree preferably in life science, nursing, pharmacy, or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.).
Minimum 10 years (12 years for Senior Director) of DSPV operations experience within the biotechnology or pharmaceutical industry, including 5 years in management position overseeing business process outsourcing vendors and relationships.
Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems.
Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels.
Knowledge of GCPs, ICH guidelines, and FDA, EMA, and other international regulations
Experience and extensive working knowledge of MedDRA, WHO-DRUG, and proprietary safety databases 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