Crinetics Pharmaceuticals
Senior Director, Pharmaceutical Strategy and Development Leader
Crinetics Pharmaceuticals, San Diego, California, United States, 92189
Crinetics is a pharmaceutical company based in San Diego, California that develops therapies for rare endocrine diseases. We were founded by scientists with a belief that better therapies, driven by rigorous innovation, lead to better lives. Our work aims to make a real difference for patients, with a robust pipeline across preclinical and clinical development, and a patient-centric, team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into a premier fully integrated endocrine company from discovery to patients. Come join our team as we transform lives.
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 functional areas to achieve optimal development and business results.
Responsibilities
Develop, refine, update, and oversee Technical Operations project plans from multiple inputs, with emphasis on alignment with strategic objectives, decomposition of major objectives into discrete WBS-level work packages, mapping of internal and cross-functional interdependencies, and 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 Corporate Development to support Due Diligence evaluations.
Qualifications
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) with a track record of success.
Broad and sound understanding of process chemistry, drug substance, drug product development, and analytical development.
Proven track record in CMC development of clinical stage programs.
Experience in multiple modalities is preferred.
Understanding of CMC integration with Non-Clinical and Clinical development, Quality, Regulatory, and Commercial areas.
Strong project management experience.
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.
Physical Demands and Work Environment Physical Activities: On a continuous basis, sit at a desk for long periods; intermittently answer telephone, and write or use a keyboard. Some walking and lifting up to 25 lbs may be required. The noise level is typically low to moderate. The physical demands described are representative of those that must be met to perform essential functions. Reasonable accommodations may be made for individuals with disabilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel You may be required to travel up to 30% of your time.
Equal Opportunity Employer Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all applicants without regard to sex, sexual orientation, gender identity/expression, pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or other beliefs, disability, marital and civil union status, age, genetic information, veteran status or any other characteristic protected by applicable laws.
Total Compensation The final salary offered will depend on experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Salary Range $214,000 - $268,000.
In addition to base pay, our total rewards program may include a discretionary annual target bonus, stock options, ESPP, and 401k match. We provide health insurance plans for employees and their families, including medical, dental, vision, basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
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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 functional areas to achieve optimal development and business results.
Responsibilities
Develop, refine, update, and oversee Technical Operations project plans from multiple inputs, with emphasis on alignment with strategic objectives, decomposition of major objectives into discrete WBS-level work packages, mapping of internal and cross-functional interdependencies, and 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 Corporate Development to support Due Diligence evaluations.
Qualifications
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) with a track record of success.
Broad and sound understanding of process chemistry, drug substance, drug product development, and analytical development.
Proven track record in CMC development of clinical stage programs.
Experience in multiple modalities is preferred.
Understanding of CMC integration with Non-Clinical and Clinical development, Quality, Regulatory, and Commercial areas.
Strong project management experience.
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.
Physical Demands and Work Environment Physical Activities: On a continuous basis, sit at a desk for long periods; intermittently answer telephone, and write or use a keyboard. Some walking and lifting up to 25 lbs may be required. The noise level is typically low to moderate. The physical demands described are representative of those that must be met to perform essential functions. Reasonable accommodations may be made for individuals with disabilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel You may be required to travel up to 30% of your time.
Equal Opportunity Employer Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all applicants without regard to sex, sexual orientation, gender identity/expression, pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or other beliefs, disability, marital and civil union status, age, genetic information, veteran status or any other characteristic protected by applicable laws.
Total Compensation The final salary offered will depend on experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Salary Range $214,000 - $268,000.
In addition to base pay, our total rewards program may include a discretionary annual target bonus, stock options, ESPP, and 401k match. We provide health insurance plans for employees and their families, including medical, dental, vision, basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
#J-18808-Ljbffr