Crinetics Pharmaceuticals, Inc
Director, Regulatory CMC
Crinetics Pharmaceuticals, Inc, California, Missouri, United States, 65018
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. 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 a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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. Join our team as we transform the lives of others.Position Summary:The Director, Regulatory CMC reports to the Senior Director, Regulatory CMC and is responsible for developing CMC regulatory strategy for Crinetics’ products and ensuring that strategy is aligned with Health Authority requirements and Crinetics’ product development objectives. The position provides support for both development stage and future marketed products including driving the development of innovative CMC strategies and providing direction to research, clinical, and manufacturing technical teams.Essential Job Functions and Responsibilities:These may include but are not limited to:
Provide strategic CMC regulatory leadership support for multiple innovative programs.Serve as the primary regulatory representative on project teams and work closely with CMC and other departments to create and execute on global regulatory strategy for our product manufacturing and registration.Lead negotiations with regulatory agencies to resolve CMC issues and oversee proactive interactions with regulators globally for initial INDs/CTAs, marketing registration applications, and post-marketing maintenance.Oversight of compilation and submission of high-quality CMC related sections of INDs/CTAs/NDAs/MAAs, including responses to questions from various regulatory authorities, working in collaboration with subject matter experts in Research, Process Development, Manufacturing, Quality, Global Supply Chain and other business partners.Maintain and be accountable for CMC regulatory timelines and support developing and maintaining CMC regulatory systems.Assess and communicate regulatory requirements to ensure all development activities comply with applicable regulations and guidelines. Manage and ensure compliance with all reporting requirements, including annual and periodic reports.Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.Support interactions with regulatory agencies during inspections.Other duties as assigned.Education and Experience:Required:
Advanced relevant life sciences degree, e.g., MS, PhD. and at least 10 years regulatory CMC experience and operating in the biotech/pharmaceutical industry. (An equivalent combination of experience and education may be considered.)A minimum of 8 years in a supervisory/people manager role.Experience with producing CMC sections from early development to pre- and post-approval submissions (e.g., INDs/BLAs/NDAs/MAAs/Annual Reports/IMPDs) and familiarity with eCTD structure and granularity requirements.Considerable experience with development of CMC development, process validation, comparability protocols, amendments, and supplements.Knowledge of both foreign and domestic regulations pertaining to the development, manufacturing and distribution of investigational and commercial drugs.Detailed knowledge of GMP, ICH guidelines, and related FDA/EMA guidance regarding CMC submission elements.Experience with electronic document control and management systems.Ability to work and prioritize several projects at once while balancing multiple and overlapping timelines.Ability to write clearly at a level appropriate to the audience and the project with careful attention to detail and accuracy with a focus on CMC regulatory writing skills.Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.Strong project management skills with ability to manage multiple projects and execute in adherence to timelines.Desire to work in a collaborative team setting.Preferred:
Experience with Orphan Drug Designation, breakthrough therapy, and direct interactions supporting health authority GMP inspections.Physical Demands and Work Environment:Physical Activities:
On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.Travel:You may be required to travel for up to 5% of your time.The Anticipated Base Salary Range:
$165,000-$220,000In 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.Equal Opportunity Employer:Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.Vaccination requirement:Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
#J-18808-Ljbffr
Provide strategic CMC regulatory leadership support for multiple innovative programs.Serve as the primary regulatory representative on project teams and work closely with CMC and other departments to create and execute on global regulatory strategy for our product manufacturing and registration.Lead negotiations with regulatory agencies to resolve CMC issues and oversee proactive interactions with regulators globally for initial INDs/CTAs, marketing registration applications, and post-marketing maintenance.Oversight of compilation and submission of high-quality CMC related sections of INDs/CTAs/NDAs/MAAs, including responses to questions from various regulatory authorities, working in collaboration with subject matter experts in Research, Process Development, Manufacturing, Quality, Global Supply Chain and other business partners.Maintain and be accountable for CMC regulatory timelines and support developing and maintaining CMC regulatory systems.Assess and communicate regulatory requirements to ensure all development activities comply with applicable regulations and guidelines. Manage and ensure compliance with all reporting requirements, including annual and periodic reports.Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.Support interactions with regulatory agencies during inspections.Other duties as assigned.Education and Experience:Required:
Advanced relevant life sciences degree, e.g., MS, PhD. and at least 10 years regulatory CMC experience and operating in the biotech/pharmaceutical industry. (An equivalent combination of experience and education may be considered.)A minimum of 8 years in a supervisory/people manager role.Experience with producing CMC sections from early development to pre- and post-approval submissions (e.g., INDs/BLAs/NDAs/MAAs/Annual Reports/IMPDs) and familiarity with eCTD structure and granularity requirements.Considerable experience with development of CMC development, process validation, comparability protocols, amendments, and supplements.Knowledge of both foreign and domestic regulations pertaining to the development, manufacturing and distribution of investigational and commercial drugs.Detailed knowledge of GMP, ICH guidelines, and related FDA/EMA guidance regarding CMC submission elements.Experience with electronic document control and management systems.Ability to work and prioritize several projects at once while balancing multiple and overlapping timelines.Ability to write clearly at a level appropriate to the audience and the project with careful attention to detail and accuracy with a focus on CMC regulatory writing skills.Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.Strong project management skills with ability to manage multiple projects and execute in adherence to timelines.Desire to work in a collaborative team setting.Preferred:
Experience with Orphan Drug Designation, breakthrough therapy, and direct interactions supporting health authority GMP inspections.Physical Demands and Work Environment:Physical Activities:
On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.Travel:You may be required to travel for up to 5% of your time.The Anticipated Base Salary Range:
$165,000-$220,000In 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.Equal Opportunity Employer:Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.Vaccination requirement:Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
#J-18808-Ljbffr