General Scope and Summary
As we advance bempikibart into late-stage development, our industry-experienced team continues to grow. We are seeking a driven, collaborative Director, Program Management to help lead bempikibart through Phase 3 development, registration, and preparation for commercialization in alopecia areata and additional indications.
The Director will lead the cross-functional Program Team’s operations and those of its sub-teams, including the Clinical Development Team and Clinical Study Teams. Working closely with functional leads across clinical development, clinical operations, regulatory affairs, CMC, nonclinical, safety, and commercial, the Director will align strategy, timelines, budgets, and risks. They will ensure critical information flows across functions and to external partners, decisions are made, documented, and acted on, and the program stays on track toward key milestones. This is a hands-on leadership role for a self-starter with exceptional communication and organizational skills and deep experience across all stages of clinical development and registration. This role will report to the Chief Business Officer.
Roles and Responsibilities
Program management and planning
- Lead and facilitate Program Team meetings and serve as the linkage point between the Program Team and its key sub-teams (including the Clinical Development Team and Clinical Study Teams), defining strategic and tactical program goals and the metrics used to track them.
- Develop and maintain the integrated program plan, including timelines, key milestones, critical path activities, and cross-functional interdependencies through registration and launch readiness.
- Manage timelines for our clinical trials and related activities
- Regularly assess challenge points and identify opportunities to accelerate the program.
Execution and governance
- Own core program management deliverables, including agendas and minutes, action item and decision logs, cross-functional program timelines, and program goals tracking, and follow up to ensure timely, accurate completion.
- Prepare clear, concise program status updates for executive leadership and, as needed, the Board.
- Ensure key decisions, commitments, and changes are communicated and handed off effectively across functions and to external partners (e.g., CROs, CDMOs).
- Drive alignment and accountability across functions, escalating issues to leadership when appropriate.
Risk, resources, and budget
- Proactively identify risks and deviations from plan, and ensure mitigation and contingency plans are in place and acted on in a timely way. Regularly assess challenge points and opportunities for acceleration.
- Partner with Finance and functional leads to estimate, track, and forecast program budget and resource needs, including external spend and FTEs. Ensure guidance is given to enable Program Team and functional leads to estimate and monitor resource requirements (external expenses, FTEs, etc.) for the program to meet its deliverables.
Infrastructure
- Develop and implement program management tools, templates, and best practices that scale as the company grows.
Qualifications
- BA/BS in life sciences or a related field required; advanced degree and project management certification (e.g., PMP) preferred.
- 7+ years of biotech or pharmaceutical industry experience, including management of clinicalstage programs and cross-functional teams; biologics experience strongly preferred.
- Direct experience managing late-stage (Phase 3) development programs; experience supporting a BLA/MAA submission preferred.
- Working knowledge of how CMC, regulatory, nonclinical, clinical development, and commercial functions interconnect across the drug development lifecycle.
- Experience in a small to mid-size biotech environment requiring both strategic oversight and hands-on execution. A flexible, adaptable, collaborative, and proactive approach as a team member who can positively and productively impact both strategic and tactical development initiatives in a fast-paced environment
- Proficiency with program management and reporting tools (e.g., Smartsheet, MS Project, or similar).
- Exceptional written, verbal, and presentation skills. Able to consolidate information from diverse sources and communicate it clearly at all levels, up to executive management.
- Demonstrated ability to lead through influence, prioritize competing workstreams, and stay detail-oriented in a fast-paced environment.
- Sound judgment and discretion in handling confidential information.
- Must be able and excited to work in person a minimum of 3 days per week at company headquarters in Waltham, MA in accordance with company in-office hours/schedule.
Director, Program Management in waltham at Unknown Company
This position is listed as full time and onsite.