Location: South San Francisco, CA - hybrid (3days/week)
The Director of Project Management will provide strategic and operational leadership for a complex drug development program currently in a first in human clinical trial. As a close partner to the Program Team Leader and a core member of the Program Team, this individual will help shape program strategy, translate that strategy into an integrated development plan, and drive the decisions and cross functional execution required to advance the asset.
This is a leadership role requiring substantial biopharmaceutical development experience and the ability to operate independently with minimal oversight. The successful candidate will influence across functions and levels, navigate complex team and executive dynamics, and distill scientific, clinical, regulatory, CMC, and operational challenges into clear options, recommendations, decisions, accountable workstreams, and achievable timelines. The role will contribute to the continued development of program management capabilities across the organization.
Key Responsibilities
- Serve as the project management lead for the program and as a strategic thought partner to the Program Team Leader, contributing an execution perspective to development strategy and major program decisions.
- Independently provide operational leadership for the program, establishing clear priorities, decision pathways, governance readiness, and accountability across the Program Team and its subteams.
- Lead development and maintenance of the integrated cross functional program strategy and plan across all contributing and impacted functions.
- Translate program strategy into measurable objectives, deliverables, dependencies, milestones, decision points, budgets, resource requirements, owners, and timelines; ensure functional plans support the overall program strategy and are internally consistent.
- Lead annual and long-range program planning, scenario development, and assessment of strategic tradeoffs across value, evidence, scope, timing, cost, resources, and risk.
- Anticipate program risks, opportunities, and cross functional dependencies; challenge assumptions and drive timely development of mitigation, contingency, and issue resolution plans.
- Synthesize complex or incomplete information into concise, decision ready options and recommendations for the Program Team, governance committees, and executive leadership.
- Lead preparation for governance reviews and critical program decisions, ensuring that the decision required, supporting evidence, tradeoffs, recommendations, and consequences of delay are clearly articulated.
- Build and sustain effective operating norms that clarify roles and decision rights, facilitate constructive debate, and hold team members accountable for commitments.
- Navigate sensitive or challenging team and executive dynamics with tact, credibility, political awareness, and composure; adapt communication and influencing approaches while preserving clarity and forward progress.
- Communicate program strategy, status, risks, and decisions accurately and succinctly to scientific, operational, and executive audiences.
- Establish fit for purpose project management practices that improve transparency, decision quality, and execution without adding unnecessary process burden.
- Share lessons learned across programs, and lead or contribute to departmental and cross organizational initiatives that strengthen program and portfolio management capabilities.
Required Qualifications
- Bachelor's degree in a scientific, technical, or related discipline; advanced degree is a plus.
- 10 or more years of experience in the biotechnology or pharmaceutical industry, including substantial experience leading complex, cross functional drug development program teams. Equivalent combinations of education and directly relevant experience will be considered.
- Direct experience co-leading first in human or early clinical development programs, with a strong understanding of the activities and decisions required to progress an asset from pre-IND through proof of concept and preparation for later stage development.
- Experience with large molecule therapeutics, such as monoclonal antibodies, therapeutic proteins, antibody drug conjugates, or other biologic modalities, is strongly preferred.
- Broad understanding of end-to-end drug development and the interdependencies among clinical, regulatory, CMC, nonclinical, translational sciences, biometrics, quality, commercial, and program strategy.
- Proven ability to lead through influence in a matrixed environment, establish credibility with technical experts and senior executives, and align stakeholders who hold different priorities or perspectives.
- Exceptional facilitation, negotiation, written communication, and executive presentation skills, including the ability to frame nuanced issues and recommendations for senior governance audiences.
- Demonstrated success managing ambiguity, competing priorities, sensitive team dynamics, conflict, and high-stakes decisions with tact, diplomacy, and composure.
- Advanced capability in integrated development planning, scenario analysis, budget and resource planning, risk management, decision tracking, and governance preparation.
- Experience coaching or mentoring cross functional team members; direct people management experience is beneficial but not required.
- Proficiency with enterprise project management and collaboration tools. Experience with Smartsheet, Microsoft Project, or comparable integrated planning platforms is preferred.
Additional Information
This position may require participation in meetings across time zones. Responsibilities may evolve as the program advances and the organization grows.