Director, Non-Clinical Development & Translational Sciences

Position Title: Director, Non-Clinical Development & Translational Sciences

Department: Translational Sciences

Reports To: VP, Research & Translational Sciences

Location: South San Francisco, CA – On-site 4 days per week (Mon to Thurs)

Job Overview

The Director of Non-Clinical Development, under the umbrella of Translational Sciences, is a strategic role at Kardigan that will oversee the design, execution, and reporting of Kardigan’s nonclinical regulatory strategy. The incumbent will provide strategic leadership and oversight for non-clinical safety and toxicology assessments over the various stages of the drug development process from early discovery (IND planning) to late stages of clinical development up to approval.

Essential Duties and Responsibilities

• Oversee the development and execution of an integrated non-clinical regulatory strategy, serving as lead for all aspects of non-clinical development at Kardigan
  • Design, execute, and oversee the in vitro/in vivo toxicology and safety pharmacology strategies, following (or exceeding) established guidelines/requirements
  • In collaboration with research and development team leaders, participate in the budgeting, prioritization, staffing, and management of non-clinical development programs.
  • Evaluate, select, monitor, and manage Contract Research Organizations (CROs), including risk assessment and management.
  • Drafting of study protocols, and peer review of studies and reports, until finalization, leading interpretation of data and oral/written communication of results
  • Support integrated development plans, regulatory submissions, and approvals through the timely provision of data and its analysis. Be accountable for nonclinical sections/contribution to INDs, Investigational Brochures, Regulatory Briefing Documents, and other relevant documentation for assigned programs
  • Partner with relevant members of research, discovery, CMC, quality assurance, and development to deliver program studies on time and in budget
  • Ensure consistency of non-clinical content and messages across scientific and non-scientific publications and materials
  • Hire, manage, and/or supervise a team of non-clinical scientists, consultants, and collaborator
• Serve as representative of the non-clinical function, and/or assign adequate designates, to project teams, and/or regulatory meetings
• Support the evaluation of safety assessment candidates, and the selection of development candidates
• Provide technical support to various departments within the company with respect to non-clinical development, including safety pharmacology and toxicology. Partner with relevant groups and departments to incorporate innovative technology and state-of-the art scientific knowledge/tools, including imaging, biomarkers, genetic, and multi-omic analyses (to name a few), to leverage non-clinical studies to accelerate the translational understanding of diseases and mechanisms of action for agents under development.
• Assist in the development, adherence, and optimization of departmental, project, and corporate budgets.
• Develop relevant Standard Operational Procedures (SOPs)

Qualifications and Preferred Skills

• DVM, MD, and/or PhD in a relevant discipline, with a minimum of 7 years of non-clinical development experience in the CRO and/or biotechnology/pharmaceutical industry.
• Demonstrable pathology training and expertise, as well as diplomate status in appropriate organization (SOT, SPS, ACVP, ECVP, ABP, etc.) is highly desirable.
• Expert understanding of Nonclinical drug development, ideally with relevant cardiovascular (CV) therapeutic area and demonstrable multi-modality experience
• Expertise in safety pharmacology and toxicology as well as study design principles meeting GLP/ICH requirements, and other Regulatory considerations, as they pertain to various therapeutic modalities (small molecules, ASOs, mRNAs, etc.)
• Leadership: Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams.
• Strategic Agility: Ability to develop and execute complex strategies.
• Ability to effectively collaborate in and across multiple functions, and with internal and external stakeholders of various backgrounds and skill sets. Skilled in establishing a collaborative and respectful environment.
• Demonstrated decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact. Publication supporting these skills are a plus.
• Communication: Excellent communication skills (both orally and written) is critical to the success of the role.
• Business Excellence: Track record of establishing business processes necessary to accomplish goals on time and in budget, demonstrable experience managing and organizing projects, people, resources, and activities, and knows what to measure and how to measure. Demonstrated ability to interpret data and project needs into actionable experiments and results.