Vice President, Oncology Clinical Research
Categories: Clinical Research
POSITION SUMMARY:
Crinetics is seeking a strategic, dynamic, and innovative Vice President of Oncology Clinical Research reporting to the Chief Medical Officer (CMO). The VP of Oncology Clinical Research will be instrumental in creating and building the Oncology Clinical Research function at Crinetics. In collaboration with executive leadership, the VP of Medical Affairs will drive oncology clinical development for Crinetics drug candidates and provide clinical guidance to support the discovery of new oncologic drug candidates. The incumbent will collaborate across the organization to identify, develop, and deliver life-changing therapies to people living with cancer and its complications.
ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
These may include but are not limited to:
- Lead clinical strategies for successful development of Crinetics drug candidates
- Serve as the Clinical Research expert to the conception and regular modifications of Target Product Profiles (TPP)
- Lead the creation of a Clinical Development Plan (CDP) for each indication being pursued, using the TPP as a guidance; including coordinating cross-functional collaborations with other departments as needed throughout the asset life cycle
- Serve as clinical oncology subject matter expert in discussions with external experts and regulatory authorities
- In collaboration with other departments (Biometrics, Clinical Operations, Medical Affairs) lead the conception, medical monitoring and medical interpretation of Crinetics oncology clinical trials
- 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
- Provide clinical leadership and lead clinical communication to upper management on trial issues, patient recruitment, investigator’s feedback, patient enrollment issues and present a plan of action for resolution of issue
- Author and/or review clinical documents required for the conduct of clinical studies, including clinical protocols (and amendments), informed consent documents, investigator brochures, and safety management plans in compliance with regulations and good clinical practices
- Lead ongoing data review, analysis, and interpretation to understand safety and efficacy profile of the investigational drugs
- Build and lead a strong team with ability to manage, mentor, and develop team as required
- Develop and manage departmental budgets that effectively achieve desired goals that are balanced with the financial objectives of the broader clinical research organization
EDUCATION AND EXPERIENCE:
- MD degree with at least 15 years clinical research experience within a biopharmaceutical company (an equivalent combination of experience and education may be considered) and a minimum of 14 years in a supervisory/leadership role
- Board certification in medical oncology or related specialty
- Broad understanding and practice of medical oncology
- Experience in interacting with the FDA and/or EU regulatory agencies. Previous successful regulatory authorization experience strongly preferred.
- 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 including past successful working relationships with Biostatistics, Data Management, Medical Writing
- Experience authoring and presenting 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, PowerPoint). Knowledge of other software preferred: Veeva (MSL, CRM) and ARISg or Argus safety reporting systems.
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.
TRAVEL:
Travel may be required up to 20% of your time, and ability to travel globally as needed.
The Anticipated Base Salary Range: $375,000 to $400,000
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
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.
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.
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.
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.