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Position:
Director/Sr. Director DMPK

Employer:
Cytokinetics

Description:

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/Experience:

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.


Location: South San Francisco

Contact: Kimberly Bridges - Kbridges@cytokinetics.com

Post Date: 8/17/2021 8:44:46 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 10/18/2021; Admin Logon
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