Job Description

Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation and neurology.

Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated small molecule medicines. Our lead programs target key innate immune modulators, including NLRP3 and cGAS. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.

Position overview:

We are seeking an experienced and highly motivated VP, Head of CMC, with responsibility for all aspects of small molecule drug manufacturing including drug substance (API), analytical, and drug product (DP) from preclinical development through clinical supplies, leading to NDA.

Key duties and responsibilities:

• Proactively identify risks and issues in CMC projects, develop solutions, and drive to resolution
• Identify, select, and manage Contract Manufacturing Organizations and consultants for process optimization, cGMP manufacture and supply of API and DP
• Hire, manage, and oversee personnel within the CMC Department, and appoint technical development leads for project teams
• Development and regular updating of API and DP forecasts for clinical programs, in coordination with clinical development team members, and associated expenditures, in coordination with finance
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with relevant regulatory standards
• Execute plans for validation and registration of API and DP as required by cGMP, ICH and FDA regulations
• Planning, authoring, and reviewing documents related to CMC sections for regulatory filings. Represent the company as the CMC expert before US and non-US regulatory authorities
• Prepare, review or edit cGMP batch records, release and stability data, CMC regulatory and Quality documents
• Prepare technical reports and oral presentations for internal stakeholders (ie. the Executive Committee, Board of Directors, Scientific Advisors) as well as external stakeholders (e.g. corporate partners)
• In coordination with Legal, negotiate (as subject matter expert) and manage CMO vendor contracts, define scopes of work, and work orders
• In coordination with IP Legal, regularly update advances that may be suitable for patent applications, and write supporting documents with relevant information for filings
• In coordination with Finance, review vendor invoices and track against work performed, and authorize payment or initiate dispute process, as appropriate

Requirements:

• 12+ years of experience in pharmaceutical/biotech industry
• Advanced degree in pharmaceutical chemistry, organic chemistry, pharmaceutical sciences or related scientific discipline preferred
• Exceptional leadership and management skills; experience in managing CRO/CMOs for the manufacture of cGMP, API and DP
• Substantial experience supporting projects in clinical development from Phase 1 through NDA, including process validation, and multiple pharmaceutical dosage forms such as tablets, capsules
• Leadership and management experience in building high-performing teams through coaching and development
• Experience with IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
• Effective at creating strategic plans and implementing prioritization