Who we are:

We're a dedicated and diverse team of passionate professionals who take our work very seriously, but not ourselves too seriously.  We are driven to deliver new medicines to cancer patients who desperately need solutions.  We are a collection of individuals with diverse backgrounds and personalities, yet all united by this purpose to ignite the precision medicine revolution by delivering targeted therapies for those battling cancers.

We are motivated by a profound sense of urgency and passion to create medicines with life-saving potential.  If you enjoy co-elevating your colleagues and want to be part of a team of like-minded individuals united by a relentless pursuit to end cancer, then Kinnate may be the home for you.

Summary Description of Role

We are seeking a Global Clinical Studies Manager (CSM or Sr. CSM level) to support expansion of the company’s Clinical Operations function. Reporting to the Senior Director, Clinical Operations, the Global Clinical Studies Manager will be responsible for the day-to-day management and execution of assigned clinical studies, including study startup, subject recruitment, study conduct, and study close-out. This individual will perform required job duties with minimal guidance to ensure study timelines, budget, and quality metrics are met, and that the study is conducted in compliance with the protocol, SOPs and applicable regulatory requirements. The ideal candidate should have experience managing or leading global early phase oncology trials.

Responsibilities

  • Lead the cross-functional study execution team to ensure that study deliverables and milestones are met.
  • Manage all aspects of clinical study execution, including oversight and day-to-day management of CROs and other service providers (central lab, drug depot, etc.) as required.
  • Accurately manage study 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.
  • Direct or lead the development of study plans, operational manuals, site training materials, and other study tools with the CRO.
  • Participate in vendor identification and selection, including development of RFPs, assessment of service provider capabilities, and vendor contract and budget negotiations.
  • Ensure selection of qualified investigators and sites.
  • Provide site, CRO, and vendor training.
  • Facilitate negotiation and finalization of investigator site agreements and budgets.
  • Ensure the proper set up and maintenance 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., country startup, 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)

Fit with Kinnate culture:

·         Ability to build strong relationships with co-workers of various backgrounds and expertise

·         Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor

·         Values-based leadership consistent with Kinnate Biopharma’s Core Values

·         Engaged in the mission of Kinnate Biopharma and acting with Flexibility and Integrity.

 

Kinnate Biopharma Inc. recently closed a $276M initial public offering and are listed on Nasdaq. Prior to that, we closed three significant venture capital financings, including our $98M Series C round in July and August 2020 and our $74.5M Series B round in December 2019.  Kinnate has a passionate and seasoned Team, guided by industry leaders in precision medicine and drug discovery, developing a focused portfolio strategy, and leveraging unique team expertise.  Our Research and Development team is based primarily in San Diego, California and a portion of our management team is based in the San Francisco Bay Area.  We are a small but growing precision oncology company with a bright future. 

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.

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