Cytokinetics, Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Working collaboratively, Cytokinetics? devoted and passionate personnel are focused on advancing novel therapeutics to dramatically improve the lives of patients. With purpose and passion, we have committed to make an important impact on serious medical illnesses.
- We are currently seeking a leader of DMPK and Analytical Chemistry to join our team. Title will be commensurate with experience (Associate ? Senior Director).
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.
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
Now is the perfect time for you to consider a move to Cytokinetics where you can put all of your skills to maximum use. You will enjoy a truly unique culture as well as a competitive benefits program.
StartUpHire - 2 years ago