Crinetics Pharmaceuticals

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 Director, Regulatory Affairs has direct responsibility for the development and execution of regulatory strategy for development programs. Works closely with the Global Regulatory Program Lead (GRL), Regulatory Affairs team members and project teams to prepare the program regulatory strategy plans, regulatory submissions (authoring, timeline planning, etc.), to support and conduct regulatory activities necessary to ensure the successful preparation and filing of regulatory submissions at Crinetics Pharmaceutical. Establishes and maintains department regulatory processes. The individual will be responsible for developing collaborative and productive partnerships internally, as well as externally with contract research/manufacturing organizations, consultants, and other vendors as required...

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Direct accountability for strategic regulatory guidance for the program development teams and oversee budget and accruals within the regulatory group.
• Focus on immediate and short-term (<2 Years) strategic planning horizon.
• Oversee/develop department policies and procedures to achieve department and corporate goals.
• Ensure adequate resources are in place to successfully complete regulatory projects and programs.
• In collaboration with program GRL, responsible for development of global regulatory strategies/regulatory program plans to support nonclinical and clinical activities across various development programs.
• Independently develop, maintain, and communicate timelines for IND submissions, CTAs, amendments, briefing documents and other regulatory documents as needed.
• In collaboration with the program GRL, independently lead execution of major regulatory submission activities, (eg, IND, CTA, Pre-IND Mtg, EOP 2 Mtg, Pre-NDA Mtg, NDA submission preparation) including development of timelines and submission strategies, leadership of cross functional submission teams, with direct responsibility for quality of submission content/execution.
• Provide regulatory leadership and strategic regulatory expertise on cross-functional product development teams to resolve complex project issues.
• Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to facilitate attainment of regulatory health authority approval.
• Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Company programs.
• Effectively interact with all contributors/cross-functional stakeholders and Regulatory Affairs management to ensure timely delivery of documents for regulatory submission.
• Independently lead, coordinate, author, critically review and provide strategic input on regulatory filing documents.
• Provide guidance to project teams to ensure complete, accurate, high quality and electronically functional regulatory submissions.
• In collaboration with the program GRL and/or senior regulatory leadership, independently prepare and present regulatory status updates, summaries of regulatory issues, and program regulatory plans to product governance committees including the program development teams, leadership teams and executive management.
• Provide critical strategic regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials and clinical study reports.
• Lead regulatory research and analysis, develop, and communicate recommendations regarding new/emerging regulations to management and project teams.
• Independently develop and maintain standard operating procedures, department working practices, templates, and style guides, as appropriate.
• Ensures the company is adhering to all applicable government regulations, submission regulations and guidelines.
• Independently function as designated US and/or international regulatory authorities contact on projects.
• Participate in the headcount planning process and determine department needs to support ongoing projects/programs.
• Lead, direct, manage, coach/mentor, and evaluate direct reports.
• Other duties as assigned.

Required Education and Experience

• Bachelor’s degree in scientific area required with a minimum of 12 years of experience in the biotechnology/pharmaceuticals industry. An equivalent combination of relevant education and applicable job experience may be considered.
• A minimum of 8 years of supervisory/management experience.
• Works effectively in a matrix cross-functional environment.
• Good business judgement and a strong understanding of the unique aspects or regulatory financials.
• Proven experience and thorough understanding of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA regulations.
• Experience and knowledge in the preparation of global regulatory submissions, i.e., US IND and/or NDA sequences, Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA).
• Demonstrated leadership, strategic thinking, collaboration, and problem-solving skills to oversee and develop in-house regulatory capabilities.
• Critical thinking, leadership skills, assertiveness, excellent negotiation, and project management skills as evidenced by past performance on drug development project teams with strong problem-solving skills.
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting.
• Knowledge of GXPs (e.g., GMPs, GLPs and GCPs).
• Excellent writing skills as they are related to preparation of regulatory documents.
• Strong oral/written, presentation and verbal communication skills with ability to influence business leaders at all levels.

Preferred

• RAC certification or equivalent is preferred.
• Good judge of risks and a keen ability to analyze options and manage outcomes.
• Demonstrated success working with external third parties and external service providers (worldwide).

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 provided 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

$169,000 - $225,000. 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.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of 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.

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.