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 as 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 Kinnate

We are seeking a Senior Manager / Associate Director, Clinical Quality Assurance who will be responsible for managing and supporting the Quality Assurance activities related to GLP and GCP for early and late-stage clinical development through commercialization. This key role in the Quality team will partner with internal stakeholders across the organization including Clinical Operations, Non-Clinical, Data Management, and Pharmacovigilance to ensure GCP compliance as well as compliance with procedures and systems.

Key Responsibilities:

·         Support the VP, Regulatory Affairs & Quality Assurance, with the development, implementation, and strict adherence to a quality assurance program.

·         Assure adherence to GxP/ICH (FDA, ex-US, country-specific) regulations, KINNATE Standard Operating Procedures (SOPs), and current industry best practices in conduct of non-clinical and clinical trials

·         Review and provide input to clinical documents such as protocols, amendments, Investigator’s Brochure (IB), Informed Consent Forms (ICFs), study plans, Clinical Study Reports (CSRs) and other relevant documents etc

·         Perform audit of Trial Master Files (eTMFs) and ensure clinical trial documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs

·         Assist in timely resolution of quality and compliance issues at non-clinical CROs, clinical CROs, clinical sites, investigator sites, laboratories, and other support services vendors

·         Assist in review and approval of deviation/non-compliance investigations, corrective actions and preventive actions (CAPAs) related to non-clinical CROs, clinical CROs, clinical sites, investigator sites, laboratories, and other support services vendors

·         Assist in qualification, management, and oversight of CSPs (non-clinical CROs, clinical CROs, clinical sites, investigator sites, laboratories, other support services vendors, and computer systems etc.)

·         Assist in inspection readiness preparation and regulatory audits

·         Participate in process improvement initiatives such as data management, trial management, investigational product management, etc

Qualifications:

 

•         A minimum of a Bachelor’s degree in scientific discipline

·        More than 7 years of relevant work experience in clinical operations and/or GCP/GLP QA roles within a pharmaceutical or biotechnology company

·         In-depth and hands-on knowledge of the current FDA, ICH, EMA, MHRA, and country-specific regulations and industry best practices regarding GMP, GLP, and GCP activities

·         Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 guidances

·         Strong knowledge of root cause analysis tools and risk assessments

·         Knowledge of drug development process, non-clinical and clinical development programs, end-to-end clinical trial processes as well as quality risk management and control tools

·         Working knowledge of CTA, IMPD, IND, and NDA submission and approval processes

·         Experience with global clinical trials and global clinical trial requirements

·         Auditing and qualification experience across full range of audit types including non-clinical CROs, clinical CROs, supporting services, and laboratories etc

·         Demonstrated experience in interpretation/implementation of global, regional regulations, and industry best practices related to GMP, GLP, and GCP activities

·         Experience in review of protocols, amendments, IB, ICF, study plans, CSR, and other relevant documents etc

·         Experience in review and approval of change controls, non-clinical and clinical operations SOPs, working instructions, quality agreements, quality investigations, root cause analysis, CAPA, and EC

We are looking to fill this role ASAP – All Application Due by Friday June 2nd

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 $153,000 – $181,000. 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

·         11 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 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.