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Senior Vice President, Pharmaceutical Development

2 months ago

Seattle, Washington, United States Mozart Therapeutics, Inc. Full time
About the Role

Mozart Therapeutics, Inc. is a biopharmaceutical company dedicated to developing novel immune engagers that target a subset of T lymphocytes to delay the onset and ameliorate pathology of autoimmune diseases. We are seeking a highly motivated and experienced individual to join our Protein Sciences group as the Senior Vice President, Pharmaceutical Development.

Key Responsibilities
  • Lead the manufacture of drug candidates molecules at all stages of development, providing strategic direction, technical leadership, and operational execution for ensuring successful CMC development activities for Mozart programs.
  • Oversee both internal and external resources, working closely with Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) to ensure the successful development and production of our cutting-edge biologic therapeutic candidates.
  • Partner with Research, Non-Clinical, Project Management, Regulatory, and Clinical functions, as well as global partners and external consultant networks, to drive CMC development and ensure regulatory compliance.
  • Develop and implement manufacturing processes that are scalable, safe, cost-effective, and environmentally friendly.
  • Manage multiple assets, ranging from development, First-in-Human, and pivotal clinical studies, to intended registrational studies and commercial launch.
  • Communicate and partner effectively with functional areas and other stakeholders to define and execute CMC strategy.
  • Identify and escalate key issues and risks, as well as resource allocation needs, as appropriate.
  • Work collaboratively with Quality Assurance and Regulatory teams to review analytical documents, stability results, manufacturing batch records, and regulatory documents related to drug candidates at all stages of CMC manufacture and approve them as required.
  • Author technical development reports, Module 3, and responsible for CMC-related sections of INDs, CTAs, NDAs, MAAs, and other regulatory submissions.
  • Represent Mozart as the CMC expert in front of regulatory authorities and other third parties, including potential business partners.
Requirements
  • Advanced degree in chemical or biological sciences; PhD or MBA preferred.
  • At least 15+ years of relevant CMC experience in the pharmaceutical industry; small molecule or experience in multiple modalities is a plus.
  • 7 years' experience leading and directly managing teams within the industry.
  • Successful track record and extensive working experience in cGMP manufacturing, leveraging, and managing CRO/CDMOs for the manufacture of regulatory starting materials and drug substances to drug product.
  • Extensive experience and track record of success in delivering timely execution of CMC activities ranging from non-GLP and IND-enabling material supply, through GMP drug product manufacturing and commercialization.
  • Understanding of cGMP compliance requirements associated with U.S., EU, ICH, and other pertinent regulatory agencies.
  • Deep knowledge of IND, IMPD, NDA, and EMA submissions; commercial launch experience desirable.
  • Experience overseeing related areas for regulatory submissions and knowledge of current regulations.
  • Demonstrated ability to model a leadership style that reduces conflict and establishes collaboration and teamwork.
  • Relevant strategic and tactical project and team leadership experience.
  • Broad understanding of analytical and formulation development for biologics and a proven track record in CMC development for clinical stage programs.
  • Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders.
  • Team player who will be able to collaborate effectively in a cross-functional matrix team environment.
  • Ability to travel domestically and/or internationally to achieve goals, when required.