The Director/Sr. Director will develop scientific strategies, engage teammates across functions and build partnerships to advance Cytokinetics research and clinical development stage programs.

Responsibilities

• Design and implement strategy across the department (project, people, space, equipment, systems, and work processes) for the support for all Discovery projects.
• Responsible for the quality and performance of all DMPK and ADME activities including interactions with CRO's and internal project partners.
• Create the vision for DMPK and ADME at Cytokinetics and craft our long-term strategic and operational model to support our growing research and development portfolio.
• Participate in study design, vendor selection, study execution, interpretation and report writing for molecules that pertain to PK and PK/PD assessment Provide assistance with in-depth quality review and interpretation of results.
• Establish and manage in vitro-in vivo correlations and use these correlations in collaboration with Pharmacology to project pre-clinical and clinical doses
• Collaborate with other scientific disciplines including Medicinal Chemistry, Muscle Biology, Pharmacology, CMC, and Pre-Clinical and Clinical Development.
• Transfer methods and protocols to CMC, pre-clinical and clinical development and collaborate in refinement activities when required.
• Resolve highly sophisticated business and scientific problems through excellent scientific judgment and broad research, development, and regulatory affairs knowledge.
• Manage department budget, including laboratory supplies, external research grants, capital expenditures, contract research personnel and projects, and external project spending.
• Extensive knowledge of preclinical drug development and the preparation of regulatory documents, e.g. INDs and NDAs.

Qualifications

• PhD in Analytical Chemistry, Drug Metabolism, Biochemistry, Chemistry, Pharmacology, or related subject area with 12+ years of drug development and proven experience in DMPK.
• Proven record of excellence with 8+ years in leadership and management of analytical, DMPK, and pharmaceutical chemists.
• Demonstrated record of driving drug discovery projects from hits to the selection of clinical candidates and the subsequent initiation of clinical trials.
• Expert knowledge and hands on experience with state-of-the-art Analytical Chemistry, all DMPK concepts (i.e., preclinical pharmacokinetics, PK/PD relationships, metabolism, bioanalysis, and in vitro and in vivo techniques applying to these concepts), and pharmaceutical sciences.
• Builds positive relationships with peers and cross-functionally with partners outside of the team to enable higher performance.
• Experience in delivering effective analytical support to Discovery and Development Chemistry.
• Excellent interpersonal, communication, and decision-making skills.
• Demonstrated ability to manage external contractors to meet/exceed Company goals.
• Must have strong negotiating skills and business oriented.