Role Description
The Medical Director, Clinical Sciences will support the development and execution of Crinetics' endocrinology portfolio as part of a multidisciplinary development team. Responsibilities include:
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Contributing to the concise clinical development plan (CCDP).
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Supporting the design and conduct of clinical trials across assigned therapeutic areas.
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Providing medical and scientific input to publications.
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Supporting Medical Affairs.
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Representing Crinetics to academic, regulatory, and patient organizations.
Qualifications
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MD degree with at least 5+ years clinical research experience within industry or academia.
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Endocrinology subspecialty board certification preferred.
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Equivalent combination of education and applicable job experience may be considered.
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Thorough knowledge of clinical medicine, clinical pharmacology, and associated disciplines (e.g., biostatistics, data management, medical writing).
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Deep understanding of strategic and operational aspects of clinical research and product development.
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Solid understanding of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.
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Familiarity with regulatory agency interactions (FDA and/or EU).
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Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials.
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Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment.
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Superior interpersonal skills focusing on collaboration and influencing capabilities.
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Strategic thinker, team leader, and individual contributor capable of working in a high growth, dynamic, science-driven environment.
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Able to conceive and execute innovative approaches to clinical development.
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Collaborative, effective leadership skills, with the ability to build and maintain strong interpersonal relationships.
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Ability to inspire and earn respect of the leadership team, Board members, and regulatory authorities.
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Ethical, with highest standards of integrity recognizing that we are the creators of hope for our patients.
Requirements
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Provide scientific and clinical direction for the development of clinical protocols, amendments, and related documents.
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Provide medical monitoring for clinical studies in collaboration with CRO medical monitors.
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Ensure that clinical trials are conducted according to GCP and all applicable regulatory requirements.
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Provide clinical and scientific input to HEOR-led Patient Reported Outcome research.
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Participate in ongoing and formal data analyses and review for CSR completion.
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Contribute to the development of clinical sections of regulatory documents.
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Lead trial-related advisory boards, investigator meetings, protocol training meetings.
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Collaborate with Medical Affairs and Commercial members to develop effective working relationships.
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Provide medical/clinical expertise to publications planning and drafting.
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Provide oversight of clinical programs across planning, execution, and completion of clinical trials.
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Attend conferences and remain current with relevant therapeutic area information.
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Serve as the external clinical "face" of Crinetics in interactions with development partners.
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Other duties as assigned.
Benefits
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Discretionary annual target bonus.
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Stock options.
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Employee Stock Purchase Plan (ESPP).
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401k match.
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Top-notch health insurance plans (medical, dental, vision, and basic life insurance).
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20 days of PTO.
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10 paid holidays.
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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.
Salary Range
The salary range for this position is: $270,000 - $298,000.