The Program Director position is a high impact, hands-on leadership role with responsibility for significant elements of program strategy and cross-functional execution. This role requires a talented individual with proven expertise in leading global cross-functional teams and driving major initiatives. This individual, in partnership with the Program Team members, will drive program strategy and ensure clear and timely communication of program strategy, implementation plans, and progress.
Lead cross-functional program team(s) to develop strategic plans for compounds integrating development, commercial, technical and financial considerations
Drive program team decision-making and management of early stage compounds to better understand the science and establish clinical development plans
Apply oncology drug development knowledge and experience to ensure that product candidates are managed in the efficient and rigorous manner as reflected in the design and conduct of studies with a high degree of technical, regulatory and commercial success
Lead scenario planning and organizational readiness for initiatives and/or projects, as required
Work closely with Translational Medicine and Research groups on the search for and identification of biomarkers, and coordinate development of biomarkers in parallel with drug development effort
Ability to translate cross-functional program issues into functional implications
Be responsible for issue identification and development of an action plan for resolution. Escalation to functional leadership and/or R&D Leadership, when needed.
Monitor and track program budget; escalate significant budget changes through the functions impacted; advocate for additional resources when needed for program success
Drive effective and impactful communication related to program strategy to ensure active management of issues/risks/decisions/opportunities related to all internal and external activities
Ensure collaboration across the Program Team to achieve maximum team effectiveness
Requires a minimum of 7 years R&D program management experience leading cross-functional teams
Experience in early clinical stage drug development in the oncology or imuno-oncology area required, with the understanding of the development process and regulatory requirements for in vitro diagnostics (IVDs) highly desirable
Lab experience with biomarker assays, particularly pathology/immunohistochemistry, flow cytometry, and DNA/RNA sequencing desirable.
Understanding of CAP/CLIA/GLP/GCP clinical diagnostics environment desired
Life sciences degree required; advanced degree preferred
Strong analytical and creative problem-solving mindset
Ability to make or drive decisions rapidly when the situation calls for it.
Ability to identify key priorities, align strategic and tactical plans, and motivate cross-functional teams and drive effective partnerships across functions
Outstanding relationship building and communication skills, including ability to navigate throughout the organization rapidly and with individuals at all levels
Managerial experience and proven effectiveness within matrix structures and within cross functional global teams.
Strong holistic perspective of drug development process and life cycle management across different functional areas including familiarity with commercial, medical affairs, clinical and pharmacology, preclinical research, finance, regulatory and compliance groups