Role Summary
Global Development Product Lead (Executive Director) leads multiple cross-functional oncology product teams from pre-clinical candidate nomination through Phase 1-2 clinical development and proof of concept, with potential handoff to late-stage development. The role drives end-to-end cross-functional strategy, coordinates milestone-driven plans, and represents the program to the external clinical community. It includes developing clinical development plans, managing cross-functional inputs, and leading enterprise-level workstreams to accelerate R&D decision making.
Responsibilities
- Leads multiple (~2-4) cross-functional oncology product teams from pre-clinical candidate nomination through Phase 1-2 clinical development and proof of concept, with potential handoff to late-stage development.
- Drives integration of an end-to-end cross-functional molecule strategy and risk mitigation plan; ensures delivery of data-driven milestones through risk identification and mitigation.
- Supports clinical trials and development strategy for early development assets and lead programs; represents the program with the external clinical community.
- Develops clinical development plans from first-in-human trials to proof-of-concept, including assessment of combinations and biomarker plans.
- Ensures cross-functional components of product plans include clinical expertise and medical monitoring of trials.
- Provides substantial support of CDP development and diligence for external innovation activities.
- Leads enterprise-level cross-functional workstreams to accelerate R&D decision making.
- Lead, develop and execute strategic development for early development assets; drive an integrated product plan with Global Product Teams to address technical uncertainties and align with future pivotal development and commercialization.
- Ensure timely execution and delivery of product milestones within budget.
- Communicate with executive management and governance committees to address program needs and provide recommendations; ensure clear and effective product presentations and communications.
- Collaborate with partners on co-development programs to deliver a shared global product strategy when applicable.
- Lead the team to set objectives, prioritize tasks, and ensure adherence to the plan and strategy.
- Manage risk by proactively identifying and resolving issues and developing contingency plans.
- Oversee early development assets’ development across specific indications or groups of indications; typically work on multiple clinical programs and provide consultation on research projects.
- Work across the organization on multifunctional teams responsible for developing early development assets (including Product Team, Global Development Team, Study team).
- Oversee development and management of clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plans, and regulatory documents.
- Provide leadership to early stage clinical scientists within a matrix team environment with clinicians, statisticians, pharmacologists, translational biologists and regulatory specialists; engage with Oncology group leaders across functions to align targets and priorities.
- Implement PK-guided dose escalation, early combination strategies, and innovations on first-in-human trials with cross-functional input.
- Oversee evaluation of safety, pharmacology, and efficacy data from studies for early development assets.
- Oversee manuscripts, abstracts, and presentations for scientific meetings and advisory boards; conduct literature reviews to support programs.
- Act as a medical resource for design and interpretation of clinical and preclinical programs; coordinate regular interactions with clinical trials networks and KOL advisory boards to consider feedback.
- Drive innovations in early clinical development and translational oncology/precision medicine approaches.
- Collaborate with cross-functional leaders to translate early preclinical discovery into therapeutic candidates.
- Coordinate with business development to establish external collaborations and foster new research projects.
- Contribute to organizational excellence as a member of the OESD department; foster a positive team environment emphasizing trust, transparency, and alignment on goals.
Qualifications
- MD or MD-PhD with 10+ years of industry experience in oncology drug development; track record in oncology clinical research including early-phase development.
- Clinical oncology experience; board certification in oncology preferred.
- Significant leadership experience in clinical, translational, or basic biomedical research related to drug development.
- Understanding of biostatistics, regulatory, pre-clinical pharmacology, and pharmaceutical sciences.
- Demonstrated scientific productivity (publications, abstracts, etc.).
- Proven scientific writing and strong communication skills.
- Proven leadership skills with ability to defend the clinical plan at governance meetings; capacity to adapt to a fast-paced environment.
- History of effective leadership in cross-functional/matrixed teams; experience managing direct reports and aligning cross-functional leaders.
- Passion for helping patients with cancer and for oncology science; proactive, strategic thinker with data-driven decision-making skills.
- Ability to motivate a team in a matrix organization with multiple stakeholders; strong verbal, written, and presentation skills.
- Effective mentoring skills; highly collaborative with strong relationship-building abilities with internal leadership, external partners, and investigators.
- Strong leadership presence with the ability to influence at enterprise level; team player who works well as a leader and contributor.
- Global perspective and ability to work with colleagues from diverse cultures and geographies.
Additional Requirements
- Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.