Manager of Biospecimen Operations

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 program currently conducting a Phase 1 clinical trial and another program expected to initiate a Phase 1 clinical trial in the first half of 2022 (subject to FDA clearance), 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

Reporting 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

Key Responsibilities:

· Lead the implementation and roll out of the departmental specimen management system

Serve as in-house sample management system administrator.
Lead the development and implementation of study specific vendor data transfer specifications.
Provide input into lab vendor evaluations and SOWs as it relates to specimen testing and data reporting.
Define and execute PK & biomarker data handling plans.
Maintain an integrated tracking and inventory log of all specimens; may provide real-time tracking.
Create, execute and/or distribute specimen management metrics, listings, and reports.
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., DRC meeting, biomarker testing schedules).
Receive, review the quality, and organize biomarker data and incorporate information into internal or external databases as needed.
Lead and conduct data cleaning activities for central/testing lab data.
Monitor and track specimen use and retention; ensure specimens are handled and tested in accordance with applicable consent and local regulations.
Support end of study activities related to specimen data and/or identifiers (i.e., data archiving, specimen deidentification, etc.).
Support the development of departmental SOPs and/or Wis.
May support central lab and testing lab identification, setup and management
May input into biomarker and PK portions of key clinical documents (protocol, ICF, ethics committee documents, etc.).
May support the development of specimen management plans and other BSO documentation.
Manage direct reports as applicable, including ongoing performance management, mentorship, and career development.
Up to approximately 25% travel may be required, consistent with project needs

The Right Stuff

· Bachelor’s Degree or Master’s Degree, preferably in a scientific discipline or health-related field

· 5+ 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.

· Working knowledge of the drug development process and familiarity with CFR, ICH GCP, and other guidances related to specimen collection, transport, processing, handling, retention, analysis in the context of clinical trials.

· Broad 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 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.

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.