Director, Clinical Research
Categories: Clinical Research
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 Director, Clinical Research will be accountable for the development and management of Crinetics’ endocrinology portfolio working within a multi-disciplined development team. The incumbent will have hands-on responsibility building the clinical development plan (CDP), designing and executing clinical trials and running programs focused on assigned therapeutic areas and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept, and full development. The incumbent will also be responsible for providing medical and scientific insight to the publications, supporting Medical Affairs activities, and representing Crinetics to a diverse range of academic, regulatory, and patient organizations.
Job Location: Remote (US)
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Develop a Clinical Development plan (CDP) for the indication of interest, build consensus and get approval from the Executive Team. Update as necessary the CDP. Contribute to the Strategic plans and Target Product Profile (TPP). This will involve focused multidisciplinary internal and external consultation and strategic planning.
- Lead the design, planning and implementation of clinical trials consistent with this CDP and present for feedback/approval to internal executive committees.
- Author clinical protocols (and in its early stages clinical trial outlines [CTO] and synopses) amendments and related documents (e.g., Informed consent).
- Collaboratively assist in drawing up project development timelines in coordination with other functions represented on development team; provide timely updates to development team.
- Provide medical monitoring for clinical studies in collaboration with CRO medical monitors.
- Ensure that clinical trials are conducted according to GCP and all applicable regulatory requirements.
- Collaborate with Health Economics and Outcomes Research to select or elaborate Patient Reported Outcome research for the studies.
- Along with Clinical Operations, ensure agreed-upon study enrollment and overall timelines for key deliverables.
- Participate in ongoing and formal data analyses and review for CSR completion and planned/actual filing activities.
- Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
- Lead trial-related advisory boards, investigator meetings, protocol training meetings.
- Collaborate with Medical Affairs and Commercial members to develop effective working relationships with key investigators, key opinion leaders and patient advocates to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
- Provide medical/clinical expertise to publications planning and drafting.
- Provide oversight and project management of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs.
- Attend conferences and remain current with relevant therapeutic area information.
- Serve as the external clinical “face” of Crinetics in interactions with development partners, and leading clinical discussions at advisory boards, as needed.
- Other duties as assigned.
Education and Experience:
Required:
- MD degree with at least 5 years clinical research experience within industry or academia. Endocrinology subspecialty board certification preferred.
- Thorough knowledge of clinical medicine, clinical pharmacology, and associated disciplines (e.g., biostatistics, data management, medical writing).
- Deep understanding of strategic and operational aspects of clinical research and product development.
Preferred:
- Excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development, developed through success in gaining approvals.
- Experience in interacting with the FDA and/or EU/or other regulatory agencies.
- Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives).
- Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment.
- Superior interpersonal skills focusing on collaboration and influencing capabilities supported by great presentation skills.
- Strategic thinker, team leader and individual contributor capable of working in a high growth, dynamic, science-driven environment.
- Able to conceive and execute innovative approaches to clinical development while taking into account the safety and the comfort of the patient.
- Can also take the role of a self-starter individual contributor, who enjoys rolling up their sleeves and digging into the details; rigorous attention to details and data, while not losing sight of the bigger picture and remaining flexible.
- Collaborative, effective leadership skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within and external to the organization.
- Ability to inspire and earn respect of the leadership team, Board members, the regulatory authorities, the investment community, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team.
- Ethical, with highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders.
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 20% of your time.
The Anticipated Base Salary Range: $207,000 – $275,000
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.
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.