Jade Biosciences is hiring a Director, CMC Project Management to facilitate CMC planning and cross-functional alignment for our drug development programs, enabling successful execution. This role requires a detail-oriented professional with exceptional forward-planning, organizational, and stakeholder management skills.
What You'll Do
- Facilitate management of CMC activities for drug development programs, ensuring completion on time, within budget, and according to company goals.
- Work closely with CMC quality assurance and CMC regulatory to ensure effective collaboration and execution of CMC deliverables.
- Maintain integrated CMC development plans across candidate programs and proactively identify critical path activities for key program milestones.
- Collaborate with cross-functional program managers to effectively communicate CMC activities and ensure alignment with overall program goals and timelines.
- Track program risks, proactively identify and resolve issues, and work cross-functionally to develop contingency plans.
- Manage relationships with external partners, vendors, and contractors to ensure smooth program execution.
- Support development and refinement of processes, tools, and systems to deliver high-quality PM support to the CMC programs.
What We're Looking For
- Bachelor's degree in a related field.
- 15+ years of experience in CMC program management within the biotech or pharmaceutical industry.
- Strong experience providing program management to CMC teams while interacting with cross-functional teams.
- Knowledge and understanding of CMC early-stage development pathways, including cell line development, drug substance and drug product manufacturing processes, analytical, formulation, and stability studies.
- Excellent organizational skills and ability to forward-plan.
- Proven track record of successful project management of complex drug development programs in a fast-paced startup environment.
- Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment.
- Proactively identifies issues and drives resolution; can anticipate key future events and adjust team priorities and plans accordingly.
- Excellent communication and interpersonal skills with the ability to influence and motivate cross-functional teams, manage a diverse set of stakeholders, and work closely with team leaders.
- Strong written and oral communication skills with strong attention to detail.
Nice to Have
- Advanced degree.
- PMP certification.
- Knowledge and understanding of CMC late-stage development, including process characterization, process and method validation, tech transfers, and comparability studies.
- Experience in managing programs for combination products.
Technical Stack
- Smartsheet
- Microsoft Timeline Pro+
Team & Environment
This role reports to the Executive Director of CMC.
Benefits & Compensation
- Compensation: $210,000 - $235,000
Work Mode
This is a remote position open to candidates in Boston, Massachusetts; San Francisco, California; Seattle, Washington; or fully remote within the United States.
Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
