Who We Are
Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer.
The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such non-responsiveness or acquired and intrinsic resistance.
Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine.
The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines. Come join us to help improve lives.
For more information, visit www.kinnate.com and follow us on LinkedIn.
Your Impact at KinnateReporting to the Director, Biospecimen Operations, the Manager of Biospecimen Operations will be an integral member of the team responsible for managing clinical biospecimens and associated laboratory data across multiple clinical studies and will assist with developing departmental infrastructure. This role will work closely with relevant internal cross-functional team members and external partners as part of their daily work. The ideal candidate will have excellent organizational and communication skills, be able to prioritize effectively and work independently on routine tasks and be adaptable and comfortable working in a fast-paced environment
· Oversee and manage the complete lifecycle of clinical biospecimens collected on Kinnate sponsored trials.
· Participate in Lab Vendor Selection process (RFP, proposal review, and bid defense activities)
· Lead bioanalytical assay method development, validation and transfer activities (i.e. shipment of reagents/materials, protocol review, input into method).
· Review and input into biomarker and PK portions of key clinical documents (protocol, ICF, ethics committee documents, etc.).
· Implement new studies in the department sample management software.
· Contribute to the departmental budget development and forecasting.
· Negotiate budgets and review financial agreements (i.e. SOWs, MSAs, etc.)
· Review and input into lab and data specifications documents that define the requirements, standards, quality control and parameters for PK and biomarker specimen collection, handling, transportation, storage, analysis and data delivery
· Manage central lab and analysis lab vendor relationships and oversee vendor day-to day activities and deliverables. Act as an escalation point for vendor issues/CAPAs
· Review and approve study invoices for specimen services and track invoices against contracts
· Lead the development of laboratory manuals and central laboratory specifications.
· Develop and execute study-specific specimen management plans. May approve specimen management plans.
· Utilize departmental software to maintain integrated tracking and inventory logs of all specimens; may provide real-time tracking consistent with study needs.
· May provide specimen collection and handling trainings at Site Initiation Visits (SIVs) and CRA training sessions.
· Identify and resolve specimen collection, processing, transportation, and testing errors/issues.
· Coordinate the retrieval and transfer for specimens between central labs and analysis labs
· Collaborate with external Project Managers to ensure PK and/or biomarker data is delivered in accordance with the SOW and study-specific timelines (i.e., data review meetings, biomarker testing schedules, etc.).
· Receive and perform a quality check on the PK and biomarker data files to ensure data set is complete.
· Reconcile specimen information captured across clinical study and vendor databases. Follow-up and resolve discrepancies through communication with sites/CROs and vendors.
· Utilize departmental software to track consent parameters, verify and document consent. Ensure that specimens are used in accordance with applicable consent and local regulations.
· Create and/or distribute specimen management metrics, listings, and reports.
· Support end of study activities related to specimen data/information (data archiving, specimen deidentification).
· Support or develop departmental SOPs and/or Wis.
· Manage direct reports as applicable, including ongoing performance management, mentorship, and career development.
· Approximately 10-20% travel may be required, consistent with project needs
Listed responsibilities are an essential, but not exhaustive, list of the expected initial duties associated with the position. The role will evolve over time and changes to individual responsibilities may occur due to business needs.
The Right Stuff
· Bachelor’s Degree or Master’s Degree, preferably in a scientific discipline or health-related field
· 5-8+ years relevant industry experience, with prior experience tracking/managing specimens and/or associated data in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
· 5+ years direct experience interfacing with and managing central lab and/or analysis vendor.
· Advanced knowledge of the drug development process and familiarity with CFR, ICH GCP, and other guidance related to specimen collection, transport, processing, handling, retention, analysis in the context of clinical trials.
· Expert knowledge of common laboratory techniques, assays and medical terminology.
· Self-disciplined, detail-oriented, and able to prioritize tasks to meet critical deadlines
· Strong interpersonal, communication, and presentation skills
· Excellent proficiency in software applications required in day-to-day job function
· Experience with data sets and Excel, understanding of data relationships and metadata
· Experience with Electronic Data Capture (EDC), Laboratory Information Management Systems (LIMS) and specimen management/tracking software and systems required.
· Ability to identify and resolve complex specimen related problems/
· 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
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
We offer a competitive total rewards package that provide our employees with the resources to pursue their goals, both at work and in their personal lives. The salary reasonably expected to be paid for this role is $120.000 to $135,300. The actual compensation and seniority level for this position will be determined based on relevant experience and qualifications. This position is eligible for an annual cash bonus and equity awards. Our employees are also eligible to receive other benefits including:
· Unlimited Paid Time Off
· 10 Company Paid Holidays - plus 2 annual paid “Refresher Days”
· Wide variety of comprehensive health, dental, and vision packages – most with minimal to no out-of-pocket expenses for employees
· Company contribution to 401k plan
· Employee stock purchase program
· Annual Massage Days
· Free local gym memberships
· Healthy Lifestyle Reimbursement Program
· Home Office Reimbursement Program
Kinnate recognizes the importance of balance and flexibility in our work environment. Physical presence at the Kinnate worksites or physical presence in the field is an essential job function of this role which the company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the company culture.
Kinnate is proud to be responsible members of our communities. Subject to applicable law, we require all our employees to be fully vaccinated and boosted against the COVID-19 virus. Therefore, all applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.
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.