Senior Manager, CMC Project Management en Stoke Therapeutics
Stoke Therapeutics · Bedford, Estados Unidos De América · Hybrid
- Professional
- Oficina en Bedford
About Stoke:
Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights
Stoke’s initial focus for its TANGO platform is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency).
Stoke has identified STK-002 as a clinical candidate for the potential treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. The company is also pursuing a potential new medicine for Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.
Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company’s proprietary approach.
Position Purpose:
The Senior Manager, CMC Project Management will have responsibility for delivering operational success across the entire development portfolio. This role will support the integrated project management for drug substance, formulation development, analytical development (drug substance and drug product) and packaging & labeling. The candidate will be accountable for team deliverables, ensuring operational success with respect to timelines, and attainment of technical, regulatory and goals/milestones. This person will also be leveraged as a thought partner for the CMC function that works closely with QA and Regulatory CMC to ensure all key stakeholders are aligned with the overall CMC strategy to support the programs. This position will report to the Director, CMC Project Management.
Key Responsibilities:
- Responsible for cross-functional project management across CMC subfunctions (drug substance, drug product, analytical, label & package) and their outsourced manufacturing partners for early phase clinical programs.
- Plan, manage, and track integrated CMC activities to ensure uninterrupted supply of clinical trial materials; escalate risks as appropriate.
- Support RFP generation and contract management with outsourced manufacturing partners.
- Support budget preparation and tracking.
- Liaison between CMC and other departments (e.g., Quality, Clinical, Regulatory) for early phase clinical programs.
- Support and/or represent CMC function at program level meetings.
- Provide project management support as needed for late phase and commercial programs.
- Coordinate with alliance management personnel for partnered programs as needed.
- Demonstrate best practices for meeting management and knowledge management.
- Other duties as assigned.
Required Skills & Experience:
- Bachelor’s/Master’s degree in a discipline relevant to project management, pharmaceutical research, development or manufacturing with relevant industry experience.
- Professional certification in project management (e.g. CAPM, PMP, PRINCE2, or equivalent) preferred.
- Minimum of 2 years of experience required in a GMP drug substance or drug product development and manufacturing environment for small molecules, oligonucleotides, polypeptides, or biologics.
- Direct experience working at CDMOs or in a role with strong CDMO oversight.
- Experience with Quality requirements for batch release and disposition, as well as general Quality Assurance procedures.
- Proven success working in cross-functional teams including QA and regulatory CMC.
- Strong scientific background and knowledge of the drug development process.
- Experience with Microsoft Project/Smartsheet, Power Point, Excel, Word along with other related software.
- Experience with preparation of integrated Gantt charts using OnePager, Office Timeline, or equivalent preferred.
- Experience in managing multiple programs at one time, can work well with different management styles to keep a project moving.
- Competency in developing, implementing, and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.
- Strong conflict management and negotiation skills.
- Superb written and oral communication skills.
- Experience with oligonucleotides is a plus.
Location(s):
This position is a hybrid position with an office setting based in our Bedford, MA location.
Travel:
This position will require approximately 10% travel.
Culture & Values:
At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center.
For more information, visit stoketherapeutics.com or follow the company on X at @StokeTx.
All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
Stoke participates in E-Verify.
