Job ID: 4915
Employer: Cytokinetics, Inc.
Position: Director DMPK and Analytical Chemistry
• 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
Post Date: 4/11/2012 8:08:11 AM