Director/Senior Director CMC Drug Development (Inhalation Products), Vant (Remote)

Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 9 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults.  Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.

As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational and medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology and rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale and initial development strategy for in-licensing opportunities; 3) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio. 

Position Summary

Roivant is seeking an experienced CMC drug development Director or Senior Director who can lead CMC development for programs focused on pulmonary and inhaled small molecule products.  Responsibilities include technical review of data, pre-formulation, vendor selection and management, formulation development, analytical development, clinical supplies manufacture, as well as clinical supplies packaging, labeling and distribution management. Additionally, working closely with the Head of CMC s/he is responsible for CMC strategy development, experimental design, planning and execution of product development activities including, stability planning, scale-up and technology transfer, validation, CMC regulatory writing (Module 3) and commercial manufacturing.

Responsibilities

• Lead CMC aspects of development including technical assessment and CMC strategy development from project initiation through commercialization and development execution using external partners
• Manage external collaborations for pharmaceutical development; pre-formulation, formulation development in the pre-IND phase of development and cGMP manufacture for oral and parenteral products to support clinical development
• Partner a cross-functional project team to ensure that project development timelines are in place and aligned with the project’s overall objectives. Manage project timelines, budgets, vendor relationships and management updates
• Proactively collaborate with QA and other members of the project team to efficiently evaluate, select, and manage contract service providers (CDMOs and CROs).  This will include technology transfer, process scale-up, design of validation strategies, and providing technical expertise with regards to routine and non-routine development and cGMP activities (e.g., deviations/investigations, process improvements, change controls, shelf-life extensions, CAPAs, etc.)
• Closely manage contract laboratories and contract manufacturers
• Closely manage the CMO tech transfer, scale up activities, integrate CMC activities into the overall timeline and manage clinical supply operations
• Manage the development and execution of studies/protocols to support development
• Develop and/or provide critical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc.). Support the creation, maintenance, improvement, and routine use of Quality Systems Contribute to the generation and protection of company intellectual property
• Manage the development and execution of master batch records and supporting documentation for INDs, NDAs, clinical supplies, and commercial manufacture
• Author and review technical sections for company’s global regulatory submissions (INDs, IMPDs, MAAs, Meeting Requests, Briefing Documents, responses to Health Authority questions, etc.) related to assigned programs
• Present quality written and verbal project updates to senior management
• Support the expeditious resolution of complex inter-departmental issues

Skills, Qualifications, and Requirements

• D. (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or closely related field and 10yr+ experience in the pharmaceutical indus