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Kardigan · 1 day ago

Director, Non-Clinical Development & Translational Sciences

South San Francisco, California, United States

Full-time

Onsite

Director/Executive

$210K/yr - $273K/yr

7+ years exp

Kardigan is a heart health company focused on making cardiovascular disease preventable and curable. The Director of Non-Clinical Development will oversee the non-clinical regulatory strategy, providing leadership for safety and toxicology assessments throughout the drug development process.

Artificial Intelligence (AI)BiopharmaHealth CareMedical

H1B Sponsor Likely

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)

Qualification

Nonclinical drug developmentSafety pharmacologyToxicology expertiseLeadership in matrix environmentPathology trainingStrategic agilityCollaboration skillsCommunication skillsAnalytical skillsBusiness process management

Required

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

Company

Kardigan

Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.

Founded in 2023

South San Francisco, California, USA

51-200 employees

https://www.kardigan.bio

H1B Sponsorship

Kardigan has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (1)