Senior Medical Director Clinical Research - Oncology

Crinetics is a pharmaceutical company based in San Diego California developing muchneeded therapies for people with endocrine diseases and endocrinerelated tumors. 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 patientcentric and teamoriented culture. Crinetics is known for its inclusive workplace culture. We are also a dogfriendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fullyintegrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary

The Senior Medical Director Clinical Research will be working within a multidisciplinary 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 handson 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 Job Functions And Responsibilities

These may include but are not limited to:

Clinical leader of one or more oncology programs being integral to developing the clinical strategy and plans.

Member of global project team(s) and development sub team(s).

Focus on immediate and shortterm <2 years) strategic planning horizon.

Develop department processes to achieve department and corporate objectives.

Contribute as the Clinical Research expert to the conception and regular modifications of the Target Product Profile (TPP).

Lead the development of the Clinical Development Plan (CDP) for each indication being pursued using the TPP as a guidance; this includes coordinating crossfunctional 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 a.o. in all topics related to the conduct and analysis of clinical study results. Use the findings and other analyses to contribute to trialrelated 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.

Contribute significantly to the preparation drafting and finalization of all the clinical sections of NDA and MAA. Lead the timely drafting of responses to questions from regulatory authorities.

Provide leadership career management and personal development to direct reports.

Other duties as assigned to meet business needs.

Required

Education and Experience:

• MD degree with at least 13 years' overall experience with 8 years in clinical development within biopharmaceutical and/or pharma companies spanning across translational medicine and/or latestage development.
• A minimum of 10 years in a leadership role leadership in a cross functional environment would be sufficient.
• Experience from clinical practice in internal medicine and/or pediatrics is preferred.
• Experience in designing planning and executing FirstinHuman studies Phase 2 proofof concept studies and preferably also global phase 3 trials with the focus on experience in bridging between discovery/research into the clinic.
• Experience with application of biomarkers.
• Experience interacting with the FDA and/or EU regulatory agencies is a plus.
• Strong general knowledge of GCP ICH guidelines and regulatory requirements and trial design that apply to clinical drug development.
• Intimate knowledge of and highlevel expertise in the daytoday 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.
• Excellent leadership skills and ability to function effectively in a fastpaced 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 sciencedriven environment.
• Able to prioritize and parallel process multiple workstreams comfortable "changing gears" and remain flexible as well as making definitive decisions.
• Selfstarter 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.
• Welldeveloped 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.
  
  

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: $288000 $343000

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 topnotch 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 multistate 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 COVID19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a twodose vaccine or two weeks since a singledose 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.