CACO Pharmaceutical & BioScience Society, CACO-PBS

Job ID: 4915

Employer: Cytokinetics, Inc.

Position: Director DMPK and Analytical Chemistry

Description: Description • Strong scientific leader with broad scope of responsibilities related to AMDE, DMPK, Bio-analysis, and TK support for programs from discovery through to clinical studies as required. These activities would include but not be limited to ADME assay suites for optimization efforts, bio-analysis, in house and contract non-GLP and GLP DMPK and Toxicokinetics (TK), as well as aspects of Quality and Analytical method development in support of the discovery and progression of drug candidates. • Have strong managerial capabilities and supervise a group of BS/MS/PhD scientists. • Manage internal and external research and development team activities to meet project milestones. • Participate effectively in R&D staff and project teams from Hit Characterization, Lead Optimization, Candidate Selection, IND preparation and beyond including support of clinical trials, product development and commercialization. • Accountable at the level of the Executive Committee for deliverables. • In the context of drug discovery, works with other departments and external resources to identify and define strategies for compound progression. • Manage ongoing technical activities including developing detailed technical work plans; selecting suitable vendors for the various activities; managing the performance of the vendors and preparing periodic updates for senior management. • Responsible for collaborating with Regulatory Affairs to prepare appropriate sections in regulatory filings. • Interface with Clinical Development and development project teams on DMPK and bio-analysis related issues. • Investigate and recommend technologies and companies for product development and research programs. • Collaborate effectively with Business Development and Legal teams in securing agreements with external parties to provide required services and collaborations. • Will also be responsible for ensuring good communication with collaborators on partnered programs and for working closely with co-project leaders from partner companies.

Requirements: • PhD in Chemistry, Pharmaceutical Sciences, Pharmacokinetics, or related scientific discipline and 7 or more years industry experience in pharmaceutical product development and cross-functional leadership (or a masters plus 10 or more years relevant industry experience). • Hands-on ability to trouble-shoot and help solve scientific and technical problems. • Excellent written and verbal communication and negotiation skills, established track-record as a team player • Ability to assimilate complex, multi-disciplinary inputs / data and develop and present recommendations to peers and senior management. • Comprehensive understanding of all aspects of AMDE / DMPK related issues from project inception through commercialization. • Demonstrated knowledge of appropriate ICH regulations and guidelines. • Ability to travel. • Direct experience with DMPK aspects of regulatory filings for pharmaceutical products • Proven project management skills • Excellent communication skills and strong interpersonal skills

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Post Date: 4/11/2012 8:08:11 AM