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Program Director, Pharmacology and Toxicology

Reporting to the Chief Development Officer, the Program Director, Pharmacology and Toxicology will be part of a cross-functional team responsible for planning and managing the pharmacology and toxicology programs for products across Caraway’s portfolio. The position will be responsible for the strategy, planning and oversight of all required studies to enable rapid advancement into and through regulatory filings and will work closely with colleagues and key external consultants across all functional disciplines. Applicants must be authorized to work in the US.

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Essential Duties and Responsibilities:

  • Collaborate on the design of non-GLP investigative and pharmacology studies to support developmental compounds
  • Work with the project team to develop in vivo efficacy packages that support compound advancement
  • In conjunction with program teams, develop toxicology strategies and provide support to research and development projects
  • Interface with contract research organizations (CROs) to request quotes and derive cost estimates, work closely with finance to develop budgets
  • Plan, execute and oversee the conduct of external GLP toxicology studies
  • Review and integrate complex data sets across multiple disciplines
  • Provide strategic advice to project teams and evaluate conclusions and the potential impact on program, indication selection, and clinical/regulatory strategy
  • Manage the preparation and presentation of nonclinical pharmacokinetic and safety data for project teams
  • Finalize efficacy and toxicology reports and all sub-vendor reports
  • Prepare toxicological risk assessments to support drug development and manufacturing
  • Work closely with colleagues in clinical development to support and defend clinical trial design plans
  • Design studies and work closely with vendors in the transfer of in-house assays and the development of novel biological assays
  • Write or oversee the writing of the in vivo pharmacology, toxicology, and DMPK sections of an IND, the toxicology and safety section of Investigator Brochures and represent in vivo pharmacology and toxicology in regulatory authority meetings
  • Work closely with internal and external colleagues to support creation of SDS and safety queries from clinical sites
  • Support the preparation of national and international regulatory submissions and interactions with governments
  • Manage direct reports, as assigned
  • Perform other related duties as assigned or directed

Desired Skills & Experience:

Proven track record as a pharm/tox leader overseeing the strategy, design, analysis, interpretation and reporting of toxicology and safety pharmacology data for discovery and development teams.  Deep experience working with early discovery teams to generate robust efficacy packages for complex indications and provide target safety assessments and to develop preclinical safety strategies and support for programs in lead optimization and preclinical development. International experience is a plus.  Excellent communication and collaboration skills across levels, functions, and organizations in a fast paced environment as well as a proven ability to execute and contribute strategically to achieve results in a virtual setting are a must. Other requirements are:

  • PhD or relevant degree in a field related to industrial pharmacology/toxicology
  • Minimum of 8-10 years of direct industry experience
  • Experience in developing toxicology programs to support early and late-stage drug development
  • Experience in incorporating pharmacokinetic endpoints in toxicology programs and a working knowledge of the software programs to achieve these endpoints
  • Ability to critically evaluate written toxicology documents for quality and acceptability of scientific interpretations
  • Strong knowledge of small molecule drug development
  • Experience in CNS or rare diseases is of benefit
  • Experience with global regulatory guidance documents (ICH /FDA) and Good Laboratory Practices (FDA and OECD)
  • Ability to prepare relevant sections of regulatory filings such as INDs/CTAs
  • Willingness to travel and monitor studies
  • Capability to manage multiple projects and shifting priorities associated with an early stage drug development company
  • Tools and concepts of project management (e.g. management of resources, planning and budgeting, risk management, contingency planning, analysis and reporting, and written and verbal communication)
  • Proficient in the use of MS Word, Excel, PowerPoint and project management software
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