Medical Director

HiberCell, Inc. is a clinical-stage biotechnology company dedicated to the advancement of novel therapeutics that overcome the foundational molecular barriers that prevent patients from living longer, cancer-free lives.

SUMMARY: The Medical Director/Monitor is responsible for global oversight and management of all medical safety aspects of Company’s product development and clinical trial execution. The successful candidate will lead the development and execution of safety strategies for products in development including surveillance planning, signal detection, evaluation and risk management. This position will collaborate cross-functionally, will lead the central pharmacovigilance partner, and will be accountable for developing and maintaining in-depth knowledge of the safety and overall benefit-risk profiles of Company products. This position will also work cross-functionally to design clinical development plans and execute clinical trials  The Medical Director/Monitor will interact with study investigators and collaborators as the protocol and investigational product expert.

CORE RESPONSIBILITIES:

Medical Monitor

• Lead the development and execution of product-specific safety surveillance and signaling plans including directing the Company’s central pharmacovigilance partner
• Provide oversight, review and assessment of individual case safety reports and other patient-level safety data taking into consideration translational safety information
• Lead ongoing, proactive safety data review and detection across available data sources, anticipate safety concerns, and escalate important safety updates to the Executive Committee in a timely fashion
• Review, interpret and summarize safety data for specific deliverables (DSURs, periodic reports, risk management plans, protocols, SAP, IB, IC, CSR, CTD)
• Present data and analyses to multiple internal/external stakeholder groups
• Collaborate cross-functionally on internal and external development and safety management teams
• Chair/co-chair Safety Review teams and Data Safety Monitoring Boards, present/co-present safety updates and findings, and provide safety expertise during key meetings (e.g. with Health Authorities, Data Safety Monitoring Boards and Investigators)
• Maintain in depth knowledge of evolving global clinical development and pharmacovigilance regulations, methodologies and technologies
• Lead the safety strategy for all medical activities on aggregate data and for clinical development documents and regulatory filing documents
• Manage responses to safety questions from regulatory authorities, ethics committees, investigators and other external parties
• Develop risk management strategies and monitoring plans for risk management effectiveness

Medical Director

• Participate in drafting clinical development plans and contribute to regulatory strategy planning
• With Senior Management, draft clinical protocols including inclusion/exclusion, safety overviews, guidance for investigators, and schedule of activities
• Work with cross-functional teams drafting regulatory documents, designing data collection tools, and developing training programs for CRO and site
• Participate in/lead Clinical Advisory Board meetings, Principal Investigator meetings, Data Safety Monitoring Boards, and Joint Development Committee panels
• Lead communications with Principal Investigators and clinical sites, responding to questions and providing protocol interpretation and guidance/management recommendations
• As needed, draft responses to health authorities, IRBs, and Scientific Review Committees
• Participate in protocol deviation review meetings/activities
• With Clinical Operations and Data Management, participate in ongoing data cleaning activities including quarterly line listing reviews and reconciliation, pre-database lock activities, and interim and final analyses

QUALIFICATIONS:

• MD or DO; Board Certified/Board Eligible or equivalent
• Minimum of 5 years of clinical experience post-residency
• Prior experience in a similar role in a global environment is preferred
• 5 years’ experience in the pharmaceutical/biotechnology industry with at least 3 years focused on clinical safety/pharmacovigilance
• Pharmacovigilance experience in Oncology is a plus
• Strong experience in the creation of medical content in periodic safety reports (PSUR, DSUR)
• Solid knowledge and understanding of safety risk management, signal detection and evaluation including pharmacovigilance regulatory requirements and general regulatory expectations
• Ability to objectively interpret, synthesize, analyze and communicate medical and scientific data
• Ability to communicate complex critical data and analyses verbally and in writing
• Experience with drug safety databases (queries, reporting, visualization tools) and MedDRA coding
• Excellent written and verbal communication skills
• Ability to work in intense, fast paced work environment and capacity to work under pressure
• Ability to effectively communicate in a cross-functional environment (with employees, colleagues, and global counterparts)
• Ability to cultivate and maintain collaborative relationships
• Proficient in Microsoft Office and applicable business software
• High degree of professionalism, and excellent clinical judgment
• Excellent teamwork and interpersonal skills
• Travel – Domestic and International (20%)