Associate Director/Director, CMC Program Leadership

MOMA Therapeutics is looking for an experienced Associate Director/Director, CMC Program LeadershipImagine joining a company where you….Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaboratesWill work with incredible humans who are committed to the discovery of transformative medicines for patientsAre needed… because patients are counting on youAbout MOMA TherapeuticsMOMA Therapeutics is a biotechnology company focused on developing inhibitors of highly dynamic proteins, namely ATPases, which play critical roles in a variety of Oncology indications. Our platform allows us to successfully prosecute drug discovery against difficult and unprecedented targets which are core cancer dependencies. MOMA is planning to initiate clinical development for two programs in 2024. About the role…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 stakeholdersHelp to establish CMC program strategy, including key activities, timelines, and budgets, in collaboration with technical experts on your team and the head of CMCOversee the execution of CMC-related development and manufacturing activities at external manufacturing partners, including technology transfer and on-site managementGuide the authoring of regulatory filings in terms of substance and scopeIdentify CMC program risks and work with the CMC team to develop contingency plansRepresent the CMC function at the program level and collaborate to develop program strategiesForge 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 companyYou have experience effectively collaborating with and managing CDMOsYou have experience authoring regulatory filings including INDsYou are familiar with solid oral dosage form developmentYou have a working knowledge of regulations and guidelines for small molecule developmentYou’ve led teams and/or projects in a dynamic fast paced environmentYou have explicit achievements that indicate your effectivenessYou’re organized and have excellent written and verbal communication skillsYou understand relationships are the key component of achieving significant resultsYou know how to drive a group to make a decisionSubject matter expertise in Drug Product or Analytical method development is a plusYou have an advanced degree (MS/Ph.D. or equivalent) in chemistry, pharmaceuticals sciences or a relevant disciplineYou 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