Carmot Therapeutics, Inc. is an ambitious undertaking, and we fully expect our company to become a dominant force in the development and commercialization of novel pharmaceutical drugs addressing large unmet needs. To support this vision, we are looking for an operational and tactically focused CMC Program Manager with device experience to assist with vendor management to support project deliverables and the development and management integrated CMC timelines. This role will report to the Associate Director, CMC/Supply Chain.
At Carmot, we do not believe in silos, and we work highly efficiently as a small team. Hence, the ideal candidate would be an excellent communicator with strong orientation to detail, and with proven collaboration skills and ability to work across functions to produce results in a timely manner. In addition, the candidate must be self-motivated with a problem-solving (e.g. “how can I help solve this problem for you”) attitude, given the highly dynamic nature of clinical development and rapid tactical changes anticipated in a small biotech company with large ambitions. As such, the role will have a direct impact on the successful execution of our CMC timelines, and therefore can have a significant impact on the company’s trajectory.
- Assist with the development and management of integrated CMC timelines for Contract Manufacturing partners (CMOs) and internal CMC and QA teams for clinical program(s) from preclinical through commercialization.
- Coordinate with Clinical Operations and Project Management to ensure up-to-date information on clinical study design, clinical study enrollment rate and timeline are available to support drug inventory planning and tracking across different projects.
- Act as a liaison with Supply Chain to ensure clear understanding of supply needs between CMC team and CMO. Provide timely escalation of issues and/or risks to clinical drug delivery.
- Coordinate and facilitate CMC program team meetings and CMO meetings (regularly scheduled and ad hoc) by providing meeting agendas, minutes, and tracking action items.
- Partner with Portfolio team to leverage Project Management tools and templates where applicable.
- Develop and provide consistent project tracking and project reporting to CMC leadership and project teams.
- Ownership of CMC budget for assigned development program(s). Own and track purchase-to-pay activities to ensure project budget goals are met. Appropriately escalate new budgetary requests for review and approval.
- Act as a liaison between CMC, CMO, and Legal groups to facilitate review and execution of contracts and business documents, including Master Service Agreements, Statements of Work, Change Orders, and Confidentiality Disclosure Agreements.
- Actively engage in identification and implementation of CMC program management process improvements to streamline communications, issue escalation/resolution, and routine reporting.
- B.S./B.A. in a scientific, medical or business discipline
- Minimum 7 years pharmaceutical industry experience, including minimum of 3 years CMC experience
- Device or combination product project management experience
- Exceptional communication and overview organizational skills
- Demonstrated ability to prioritize and plan realistic deadlines
- Team-oriented, with excellent interpersonal skills (i.e. adaptable, flexible, collaborative)
- Flexible, organized, and adaptable with strong collaboration/team skills
- Fluent in project management tools such as Excel, Project, and/or Smartsheet
- PMP certification preferred
- Local candidates preferred (San Francisco Bay Area)
Senior Associate: 110k-149k
Carmot offers a competitive salary, participation in our stock option plan, 401K retirement with company contribution and comprehensive benefits.
Carmot Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.