Senior Director, Pharmaceutical Strategy and Development Leader
About The Position
Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Come join our team as we transform the lives of others. Position Summary: The Senior Director, Pharmaceutical Development Team Leader (PDTL) is responsible for developing and leading the execution of comprehensive, compound-specific Technical Operations strategies to meet the global project team's (GPT) needs. This role provides leadership to interdisciplinary teams, managing multiple assets through various stages of development, and collaborates with various functional areas to achieve optimal development and business results.
Requirements
- MSc or PhD in a relevant technical/scientific discipline.
- 15+ years of CMC experience in all phases of development, including regulatory submission (IND, NDA/MAA, IMPD) experience with a strong track record of success.
- Broad and sound understanding of process chemistry, drug product development, and analytical development.
- Proven track record in CMC development of clinical stage programs.
- Solid understanding of CMC integration with Non-Clinical and Clinical development, Quality, Regulatory, and Commercial areas.
- Demonstrated strong project management experience.
- Relevant strategic and tactical project leadership experience.
- Excellent verbal and written communication skills.
- Experience in leading empowered, highly collaborative matrix teams.
- Keen sense for value of investment and ability to manage ambiguity.
Nice To Haves
- Experience in multiple modalities is preferred.
Responsibilities
- Develop, refine, update, and oversee Technical Operations project plans from multiple inputs, with emphasis on the alignment of these plans with strategic objectives, the decomposition of major objectives into discrete WBS-level work packages, the mapping of internal and cross-functional interdependencies, and the management of project risks.
- Perform detailed scenario planning where significant ambiguity is present and map out the scope, cost, timeline, and risk aspects of each scenario.
- Provide leadership to interdisciplinary matrix teams responsible for developing and executing compound-specific integrated Technical Operations strategies.
- Manage multiple assets from candidate nomination to commercial formulation and manufacturing processes.
- Represent the Technical Operations organization on GPTs and collaborate with Clinical, Commercial, Regulatory, and other functional areas to integrate Technical Operations plans/activities into GPT goals and objectives.
- Communicate and partner effectively with stakeholders to define and execute Technical Operations strategy for projects.
- Identify and escalate key issues and risks, as well as resource allocation needs.
- Critically review relevant documents, including Technical Operations regulatory submissions and briefing booklets.
- Promote best practices and lead improvement opportunities.
- Partner with the Corporate Development to support Due Diligence evaluations.
Benefits
- In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
- We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
251-500 employees
