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 Executive Director, Regulatory Affairs will lead the Regulatory Affairs Strategy functions to support our clinical development programs (Phase 1, 2, 3) and planned future commercial launch. This individual will report to the Vice President of Regulatory Affairs and be integral to designing and advancing company’s effort to discover, develop and commercialize small molecule therapeutics for rare endocrine disorders and endocrine-related tumors...

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Create and implement regulatory strategy for multiple Crinetics’ products or indications.
• Lead product teams and direct senior and executive management on global regulatory strategy for Crinetics’ drug development programs.
• Articulate complex regulatory challenges and opportunities to project teams and external stakeholders to support global development and commercialization of drug candidates.
• Manage interactions and communications with FDA and ex-US regulatory authorities with the goal of achieving company objectives.
• Responsible for all aspects of assigned product regulatory dossiers (including INDs, CTA, IMPDs, NDAs, DMFs, briefing packages, MAAs, or other regulatory dossier).
• Define strategies and objectives for as well as author, review, and/or edit regulatory documents and presentations, as necessary.
• Responsible for strategic planning and preparation for meetings and follow-up with the regulatory authorities including defining goals and desired outcomes for interactions as well as preparation of meeting agenda, briefing packages and meeting minutes.
• Create and implement strategies to ensure programs are within the framework of published guidance documents and identify areas of risk.
• Develop and be accountable for regulatory program timelines.
• Monitor, communicate and manage budgets and headcount requirements for their functional area.
• Set clear outcomes/deliverables for projects and own them, staying accountable to the company management team.
• Develop relationships with external parties (e.g., CROs, consultants, QA and regulatory professionals) and stay current on industry trends and practices.
• Set high standards on deliverables while managing risks and timelines.
• Create systems/policies for the Regulatory department ensuring compliance to regulation and global standards.
• Lead initiatives in developing areas of regulatory policy and technology, including regulatory information management.
• Manage and provide guidance/training for regulatory staff members. Provide regular feedback and coaching for their professional development.

Required Education and Experience

• Minimum BS in biological sciences or related discipline with at least 15 years of Regulatory Affairs experience in a biopharmaceutical company with a proven record of significant regulatory experience and accomplishments.
• At least 12 years in a management role overseeing individuals in a high performing team environment.
• Expert knowledge and understanding of US CFR requirements for investigational and commercial products. Thorough knowledge of EU requirements for clinical trials applications and marketing authorizations.
• RAC certification or equivalent is preferred.
• Prior experience working at a small company with wide-ranging related responsibilities is desired.
• Prior experience in drug development functions (e.g., CMC, Nonclinical and Clinical) is desired.
• Prior experience managing third parties and external service providers (worldwide) and consultants is preferred.
• Exceptional writing skills related to preparation of regulatory documents.
• Exceptional interpersonal skills with strong oral/written communication and presentation skills.
• Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved.
• Excellent problem-solving ability.
• Expert command of GXPs (e.g., GMPs, GLPs and GCPs).
• Knowledge and experience with emerging regulatory technologies and information management systems.
• Leadership and management skills, and demonstrated qualities in this area.
• Demonstration of cross-functional understanding related to drug development.
• Excellent judgement of risks and a keen ability to analyze options and manage outcomes.
• Well versed with the latest trends in the drug development industry.

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.

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 for up to 10% of your time.

The Anticipated Base Salary Range

$249,000-$309,000.

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.