Senior Director, Regulatory Affairs

Crinetics is a pharmaceutical company based in San Diego, California, developing 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 a robust preclinical and clinical development pipeline. 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. Join our team as we transform the lives of others.

Position Summary:

The Senior 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 Functions and Responsibilities:

These may include but are not limited to:

Accountable for creation and implementation of regulatory strategy for Crinetics’ products or indications.

Focus on immediate and short-term (<2 Years) strategic horizon.

Develop and oversee department policies and procedures to achieve department and corporate goals.

Provide leadership for product teams and direction to senior management on global regulatory strategy for all Crinetics’ drug development programs.

Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.

Accountable for management of interactions and communications with FDA and ex-US regulatory authorities with the goal of achieving company objectives.

Develop and submit regulatory dossier (including INDs, CTA, IMPDs, NDAs, DMF’s, briefing packages, MAA’s, 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.

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 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 new systems/policies and oversee these for compliance.

Manage and provide guidance/training for regulatory staff members. Provide regular feedback and coaching for their professional development.

Other duties as assigned.

Education and Experience:

Required:

• 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 10 years in a management or supervisory role overseeing individuals in a high performing team environment.
• Thorough knowledge and understanding of US CFR requirements for investigational and commercial products. Familiar with EU requirements for clinical trials applications and marketing authorizations.
• 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.
• Ability to interact, present and influence various internal and external audiences; like leadership team, program teams, Board of Directors, conferences, and other internal/external forums.
• Ability to influence leaders at all levels.
• Excellent writing skills as they relate to preparation of regulatory documents.
• Excellent 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.
• Excellent command of GXPs (e.g., GMPs, GLPs and GCPs).
• Leadership and management skills, and, demonstrated qualities in this area.
• Demonstration of cross-functional understanding related to drug development.
• Good judge of risks and a keen ability to analyze options and manage outcomes.
• Well versed with the latest trends in the drug development industry.
• Must possess proficient knowledge of Smartsheet, SharePoint, eCTD publishing environments, and familiarity with Veeva and Lorenz systems.
  
  

Preferred:

• Experience in rare disease and oncology-focus programs is highly preferred.
• Prior experience managing third parties and external service providers (worldwide) and consultants is preferred.
• RAC certification or equivalent is desired.
  
  

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: $220,000 - $269,000

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.