Location: Cambridge MA
Job Code: PM2020
Cambridge, MA-based H3 Biomedicine (H3B) is a leading company in cancer genomics driven drug discovery, delivering on the promise of precision medicine. The company was launched in 2011 with an unprecedented $200 million in initial funding from Eisai, plus a continued ongoing commitment to fund H3B’s robust discovery pipeline and clinical programs. Now with three clinical stage anti-cancer molecules in active development, H3B is able to uniquely leverage distinct insights from cancer genomics and real-life patient data to advance its projects to clinical proof of concept and beyond. H3B embraces a novel business model in which it collaborates with Eisai, a leading global pharmaceutical company, to create a prolific drug discovery engine and partnership platform.
H3 is seeking a motivated Program Manager (PM) to join as a key member of our R&D teams. The candidate, together with the Program Leader (PL), will be responsible for planning and managing the execution of oncology drug discovery programs from target discovery through to First in Human studies and late phase clinical development. The PM will be responsible for building high performing global multi-disciplinary teams with our pharmaceutical partner to deliver on corporate strategy and goals. Critical to success is a thorough understanding of the drug development process and a strong ability to anticipate and navigate through challenges. This position will report into the Head of Portfolio and Program Management.
Principal Duties and Responsibilities
- Lead project planning efforts to IND submission and execution of early clinical studies
- Provide operational leadership and establish processes to execute on overall program strategy
- Create and maintain web-based program team pages and broader communication tools to executive leadership
- Identify project challenges, develop options, scenarios, recommendations, risk mitigation strategies and integrated operational plans to achieve program objectives
- Facilitate team meetings and provide regular timeline update, create agendas/minutes and ensure critical actions items are addressed in a timely manner
- Drive document generation in preparation for governance approvals. Proactively identify and drive project and resource priorities that align with program objectives
- Maintain program-related documentation (including the program Gantt, decision log, and risk register) and ensure appropriate archiving and access to shared information and critical program documents
- Ensure effective communication within the team and to key internal and external stakeholders/governance
- Facilitate alignment and cross-functional communication between discovery, late phase research, CMC, clinical and regulatory to enable the team to meet program goals
- Identify and manage subteams necessary for program success (including, but not limited to - translational, clinical subteams, etc.) and ensure consistent alignment of all team members with asset strategy set by the global program team
- Support optimization of development plans by evaluating assumptions and incorporation of new inputs as the projects progress through development
- Relevant Scientific Degree (BS, MS or PhD)
- 5-10 years prior Biotech/Pharmaceutical experience as a program manager preferred
- Solid understanding of the principles, concepts, practices and standards of pharmaceutical project management
- Prior participation in successful IND submissions is a plus
- Strong presentation skills and ability to organize/prioritize tasks in a timely and accurate manner
- Some late phase (Phase 2-3) experience preferred
- Excellent interpersonal, organizational, verbal and written communication skills
- Thrives in a collaborative and dynamic team environment
- Computer programs systems: Highly Proficient with the following MS Office (Word, Excel, Powerpoint), familiarity with Project Management software, SharePoint and Webex (or other similar systems)
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.