Senior Medical Director, Oncology

Categories: Clinical Research
POSITION SUMMARY:
The Senior Medical Director, Oncology will be working within a multi-disciplinary team and will be accountable for developing the strategy and the Clinical Development Plan for one or more indications for a specific Crinetics’ compound.  The incumbent will have hands-on responsibility designing, executing and analyzing clinical trials. The incumbent will have a key role in the understanding and interpretation of the results from these studies as well as the preparation of the summary documents needed for a global submission to regulatory authorities.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

  • Contribute as the Clinical Research expert to the conception and regular modifications of the Target Product Profile (TPP)
  • Lead the development the Clinical Development Plan (CDP) for each indication being pursued, using the TPP as a guidance; this includes coordinating cross-functional collaborations with other departments as needed throughout the asset life cycle
  • Conceive and write the Clinical Study Outline for each study in the CDP
  • Lead the discussions and oversee the writing of the study synopsis, study protocol and its amendments. This entails guiding the internal discussions of the successive drafts, providing data analyses to guide medical decisions, consulting with external Medical Experts and Regulatory authorities
  • Review or oversee the review on a regular basis the data input in the EDC for events of interest or needing further investigation and all reports generated from ongoing clinical studies (see next bullet also) and trend analyses
  • Prepare in cooperation with biometrics and pharmacovigilance periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) and review these for discussion with clinical team
  • Collaborate with other departments (Biometrics, Clinical Operations, Medical Affairs) in all topics related to the conduct and analysis of clinical study results
  • Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings
  • Contribute to the development of relevant sections of regulatory documents such as amendments to protocols, briefing books, safety updates, responses to Health Authorities questions and collaborate with Regulatory Affairs in the preparation of regulatory interactions
  • Lead the preparation, drafting and finalization of all the clinical sections of NDA and MAA while incorporating the clinicians’ perspective. Lead the timely drafting of clinical responses to questions from regulatory authorities
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
  • MD degree with at least 13 years clinical research experience within a biopharmaceutical company combined with a minimum of 5 yrs hospital clinical practice (an equivalent combination of experience and education may be considered)
  • Subspecialty board certification in endocrinology or oncology or gastroenterology preferred
  • Broad understanding and practice of endocrinology, internal medicine or gastroenterology and clinical pharmacology
  • Strong general knowledge of GCP, ICH guidelines and regulatory requirements that apply to clinical drug development
  • 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, drafting of SAE narratives) including the application of Biostatistics, Data Management, Medical Writing
  • Experience in interacting with the FDA and/or EU regulatory agencies
  • Having authored and presented oral and poster presentations at international congresses
  • Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment
  • Strong project planning, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems
  • Ability to work independently and collaboratively, prioritizing tasks efficiently and meeting clinical and corporate timelines
  • Strategic thinker, team leader and individual contributor capable of working in a high growth, dynamic, science-driven environment
  • Able to prioritize and parallel process multiple workstreams, comfortable “changing gears” and remaining flexible, as well as making definitive decisions
  • Self-starter, 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
  • Able to conceive and execute innovative approaches to clinical development
  • Ability to inspire and earn respect of the leadership team, Board members, the investment community, colleagues, and staff
  • Respectful of the ideas and experience of all members of the Crinetics team
  • Well-developed presentation and written communication skills; effective at board level, as well as with the scientific/medical community, advisers, and colleagues
  • 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
TECHNICAL KNOWLEDGE REQUIRED:
Equipment:   PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, Power Point); TEAMS and other collaborative applications.

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
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 20 lbs. may be required.  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.

TRAVEL:
Travel may be required up to 25 % of your time (domestic and internationally)

The Anticipated Base Salary Range: $250,000.00 – $310,000.00
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 December.

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.

ABOUT CRINETICS:
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine and endocrine-related cancer therapeutics company. Crinetics’ benefit package includes health insurance, stock options, a 401k, paid time off, and the company provides a dog-friendly work environment.