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
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
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.
- Lead the
cross-functional study execution team to ensure that study deliverables
and milestones are met.
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.
manage study budgets, including accruals reporting and forecasting,
invoice review, and oversight of investigator grants.
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.
in vendor identification and selection, including development of RFPs, assessment
of service provider capabilities, and vendor contract and budget
selection of qualified investigators and sites.
site, CRO, and vendor training.
negotiation and finalization of investigator site agreements and budgets.
the proper set up and maintenance of the Trial Master File (TMF),
including periodic review.
and maintain the clinicaltrials.gov listing for assigned studies.
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.
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
and able to prioritize tasks to meet critical deadlines
Demonstrated critical thinking,
problem-solving, and negotiation skills
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
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.
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.