Vice President, Chemistry
Reporting to the Chief Scientific Officer, VP of Chemistry will lead the company’s discovery and process chemistry, preclinical and clinical manufacturing, and related CMC programs through commercialization. S/he employs leadership, focus, and strategy to manage the science, technology, and build a team that is able to progress therapeutic candidate compounds from early discovery through the clinic to approval.
The VP of Chemistry will provide leadership and support to project teams with cross-functional interactions across research, pharmacology/toxicology, clinical, regulatory and marketing as well as leadership team and senior leaders to ensure the business meets critical milestones and objectives. In addition, the incumbent needs to be a champion for innovation and lean product development as well as maintain contact with the scientific and pharmaceutical communities to stay current in the field and industry.
· Oversight of chemistry programs, ensuring efficiency and success, from discovery through clinical development to approval
· Plan, implement and supervise discovery chemistry and process chemistry programs, directing efforts to ensure deliverables are met according to specified timelines, budgets, quality and resources, working with internal and external project teams, research organizations, regulatory authorities and other stakeholders.
· Participate at a leadership level in multidisciplinary scientific teams driving product development programs and projects. Coordinate and prioritize resources across projects, managing links between projects and the overall costs and risks of each program.
· Manages external service contracts and collaborations, including CRO activities and industry and academic collaborators.
· Provide oversight for medicinal chemistry and process chemistry teams, and provide co-leadership for pharmacology, toxicology, formulation and analytical development to support success and quality of manufacturing and operations
· Provides input to and executes on funding strategies through grants, and/or corporate partnerships.
· Maintains quality control and high standards throughout the lifecycle of each project. Identify areas of best practice and process improvement.
· Responsible for CMC sections of regulatory filings
· In collaboration with Quality, responsible for GMP and CMC quality systems
· Business Acumen and Leadership:
o Identifies, establishes and executes a clear, strategic direction for research and development
o Delivers on the organization’s strategy, goals, and business transformation initiatives.
· Provides budget oversight, scientific expertise, resource plans, and performance support for the research & development functions. Planning and costing of projects along effective timelines derived to achieve critical go-no-go decisions during product development.
· Presentation of programs at internal and external meetings and conferences.
· Ensure efficient cooperation, coordination and integration between the R&D function and other functions.
· Advanced degree and technical knowledge in drug discovery related field including Ph.D., or equivalent; a minimum of 10-15 years industry experience in pharmaceutical companies and/or biotech companies. Project leadership of a program that transitions from discovery past clinical POC would be a plus.
· Experience in support of oncology programs a plus
· Project leadership of a program that transitioned from discovery through clinical proof of concept a plus
· Knowledge of GLP, GCP, GMP and other regulatory requirements a plus
· Demonstrable excellence in the management of skilled teams, including other PhDs
· Excellent track record in building pipeline of high quality oncology drug candidates; demonstrated success in driving pipeline through clinical development
· Experience compiling experimental protocols, R&D documentation, preclinical and clinical study reports, publications, and regulatory documents.
· Experience in the preparation, prosecution, and defense of patents and intellectual property
· Product development; has successfully transitioned oncology discovery programs to the clinic. Experience in filing successful NDA and commercial experience a plus.
· Proven track record developing and managing R&D strategic and operating plans, budgets as well as recruiting and managing a team in a biotech research environment
· Provides vision and strategy for the future direction of company’s technology platform and product pipeline
· Working knowledge of all aspects of the drug development process and the ability to identify and resolve complex methodological issues relating to programs.
· Exceptional management and interpersonal skills; build and lead outstanding discovery and preclinical team/capability
· Forward thinker with the ability to identify, synthesize and act upon strategic information and changes within the environment while managing multiple projects efficiently.