Manager, Clinical Studies
Who We Are
Kinnate is a rapidly growing, clinical stage precision oncology company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers. Kinnate’s mission is to expand the reach of targeted therapeutics by developing products for underserved populations. With our lead RAF and FGFR programs currently conducting Phase 1 clinical trials, it is a very exciting time to join Kinnate! In addition to the promising developments in our pipeline, Kinnate is financially strong with approximately $324.9 million of cash, cash equivalents and investments as of December 31, 2021, which is expected to fund current operations, including initiation of multiple registrational studies, into the second half of 2023. Based in San Francisco and San Diego, California, the Kinnate team is composed of drug discovery experts supported by a distinguished group of scientific advisors.
Kinnate is an employee-focused company providing a best-in-class benefits package which includes: cash salaries and bonuses and equity awards for all employees; employee stock purchase program; unlimited paid time off; annual paid “refresher” days for all employees; annual massage days for all employees; highly subsidized health benefits packages with a wide variety of provider options and minimal to no out of pocket expenses for employees; monthly stipend for employees who elect no health coverage through Kinnate; life and accidental death and disability insurance; company contribution to 401k plan; flexible office and remote work options; free local gym memberships; healthy lifestyle reimbursement program; home office reimbursement program; and commuter and walking/biking benefits.
For more information, please visit www.kinnate.com.
Your impact at Kinnate
We are seeking a Clinical Studies Manager (CSM) to support the company’s ongoing clinical programs. Reporting to the Director, Clinical Operations, the CSM will be responsible for day-to-day management of assigned clinical vendors and regions. This individual will perform required job duties in collaboration with the lead CSM and extended study team members. The CSM will support completion of study timelines, adherence to budget, and overall study quality. The ideal candidate should have experience conducting and managing global early phase oncology trials.
- Participate in vendor identification and selection, including development of RFPs, assessment of service provider capabilities, and vendor contract and budget negotiations.
- Provide day-to-day management of clinical service providers (eg., recruitment vendors, regional CROs, etc.) to ensure deliverables and contractual obligations are met.
- Accurately manage vendor budgets, including accruals reporting and forecasting, invoice review, and oversight of investigator grants.
- Provide operational input into the development of the clinical study protocol, informed consent form, case report forms, and other study-level documents.
- Develop vendor study plans, operational manuals, site training materials, and other study tools.
- Ensure selection of qualified investigators and sites.
- Provide site, CRO, and vendor training.
- Facilitate negotiation and finalization of investigator site agreements and budgets.
- Provide oversight of the Trial Master File (TMF), including periodic review.
- Initiate and maintain the clinicaltrials.gov listing for assigned studies.
- Proactively identify, communicate, and remediate study issues.
- Accurately track key study activities (eg., vendor metrics, country, site activation, patient recruitment, patient status, data collection, data review, etc.) and maintain study metrics for routine reporting to the internal project team and management.
- Participate in development and/or review of department SOPs.
- Approximately 20% travel may be required, consistent with project needs.
The Right Stuff
- Bachelor’s Degree or equivalent, preferably in a scientific discipline or health-related field.
- 5+ years prior experience in a clinical operations role supporting or managing clinical trials; sponsor-side and early phase experience preferred
- Prior experience with global oncology clinical studies required
- Prior experience with vendor selection and vendor management required
- Ability to work across multiple studies/multiple programs as required
- Thorough knowledge of ICH-GCP guidelines and FDA regulations
- Self-disciplined, detail-oriented, and able to prioritize tasks to meet critical deadlines
- Demonstrated critical thinking, problem-solving, and negotiation skills
- Strong interpersonal, communication, and presentation skills
- Excellent proficiency in software applications required in day-to-day job function (communication, task management, tracking, and document development)
NOTE: This position summary is not intended to be all-inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization.
Kinnate is a science-driven company and we are proud to be responsible members of our communities. Subject to applicable law, we require all of our employees to be fully vaccinated and boosted against the COVID19 virus.
EEO & Employment Eligibility
Kinnate Biopharma Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Kinnate Biopharma Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of applicable law.
Recruitment & Staffing Agencies: Kinnate Biopharma Inc. does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Kinnate or its employees is strictly prohibited unless contacted directly by Kinnate’s internal HR Team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Kinnate, and Kinnate will not owe any referral or other fees with respect thereto.