Executive Director/VP, Preclinical Development
Reporting to the Chief Scientific Officer, the Executive Director/VP of Preclinical Development will lead the company’s preclinical drug development program(s) from pre-IND through approval, lifecycle management of existing products, and operations. S/he employs leadership, focus, and strategy to manage the science, technology, and build a team that is able to progress therapeutic candidates from early discovery through the clinic.
The Director of Preclinical Development will provide leadership and support to project teams with cross-functional interactions across research, pharmacology/toxicology, manufacturing, 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.
· Contribute to ongoing discovery lead optimization programs to ensure a smooth transition to development.
· Oversight of pre-clinical development programs, ensuring efficiency and success, from pre-IND through approval.
· Build a best-in class preclinical development program at Cyteir, and develop systems that allow to go from nomination to IND in no more than one year.
· Oversee pre-clinical development plans to assure that they meet regulatory requirements in major regions and that the studies carried out under the plan lead to successful regulatory submissions, IND submissions, and approvals
· Plan, implement and supervise studies to ensure study deliverables are met according to specified timelines, budgets, quality and resources, working in close collaboration with internal and external stakeholders including project teams, research organizations, regulatory authorities and other stakeholders.
· Leads multidisciplinary scientific teams in product development programs and projects for pre-clinical compounds. Coordinates and prioritizes resources across development 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 for pre-clinical studies.
· Provide oversight to pharmacology, toxicology, and collaborate closely with head of chemistry on formulation and analytical development to support success and quality of manufacturing operations.
· Provides input 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.
· In collaboration with Quality and Regulatory, establish SOPs to assure GXP compliance, and oversee training, implementation, and documentation of procedures throughout the pre-clinical department.
· Review and approve study reports, author or review and approve regulatory submissions from Pre-IND submission through NDA, including summary documents. Respond to regulatory requests relating to preclinical studies or data.
· Work closely with regulatory, clinical, and drug safety to establish safety monitoring plans in clinical trials based on preclinical findings.
· Responsible for authoring or reviewing and updating preclinical sections in the Investigator Brochure, and updating cross-functional teams on relevant new safety findings from pre-clinical studies.
· 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.
· Ensures 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., M.D., D.V.M or Pharm. D; a minimum of 10 years industry experience in pharmaceutical companies and/or biotech companies working in oncology with small molecules is preferred.
· 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 IND
· Experience compiling R&D, preclinical and clinical study protocols, reports, and publications.
· Product development; has successfully brought products to the clinic, and has been responsible for pre-clinical sections of successful NDAs
· Publications and presentations in the field of cancer biology
· 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
· Support preclinical development particularly in PK, PD and toxicology. Contribute to protocol design in terms of PK and PD sampling time/schedule and PD marker selection
· Provides vision and strategy for the future direction of company’s technology platform and product pipeline
· Demonstrable expertise relating to all aspects of the drug development process and the ability to identify and resolve complex methodological issues relating to programs.
· Knowledge of GLP, GCP, GMP, ICH guidelines and other regulatory requirements (especially FDA and EMEA).
· 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.