Associate Director/Director, CMC Program Leadership

MOMA Therapeutics is seeking an Associate Director/Director of CMC Project Leadership to join our growing development team as we drive two small molecule programs into clinical development. In this role, you will lead small molecule CMC teams consisting of technical leads and other key stakeholders through preclinical development, IND filings and into clinical development. You will help establish CMC program strategy, including key activities, timelines, and budgets, in collaboration with technical experts on your team and the head of CMC. You'll oversee the execution of CMC-related development and manufacturing activities at external manufacturing partners. When risks to the CMC program arise, you'll identify them and work with the CMC team to develop contingency plans. You will represent the CMC function at the program level and collaborate to develop the overall program strategy.

MOMA's development programs require independence in a highly dynamic environment. Your ability solve address problems under pressure will be fundamental to operating in this role. Your ability to build relationships, both internally and externally, and operate in a lean environment will enable success for you and our programs.

In this role you will…

• Lead small molecule CMC teams comprised of technical leads and key stakeholders

• Help to establish CMC program strategy, including key activities, timelines, and budgets, in collaboration with technical experts on your team and the head of CMC

• Oversee the execution of CMC-related development and manufacturing activities at external manufacturing partners, including technology transfer and on-site management

• Guide the authoring of regulatory filings in terms of substance and scope

• Identify CMC program risks and work with the CMC team to develop contingency plans

• Represent the CMC function at the program level and collaborate to develop program strategies

• Forge close working relationships across disciplines and with external partners and consultants to advance programs through clinical development

About you…

• You have at least 7 years of experience in small molecule CMC, including experience in an early-stage biotechnology company

• You have experience effectively collaborating with and managing CDMOs

• You have experience authoring regulatory filings including INDs

• You are familiar with solid oral dosage form development

• You have a working knowledge of regulations and guidelines for small molecule development

• You've led teams and/or projects in a dynamic fast paced environment

• You have explicit achievements that indicate your effectiveness

• You're organized and have excellent written and verbal communication skills

• You understand relationships are the key component of achieving significant results

• You know how to drive a group to make a decision

• Subject matter expertise in Drug Product or Analytical method development is a plus

• You have an advanced degree (MS/Ph.D. or equivalent) in chemistry, pharmaceuticals sciences or a relevant discipline

• You work hard, you are kind to others, and you enjoy being a part of a collaborative team that gets stuff done in an environment where scientific data rules the day

MOMA Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.