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 Kinnate
We are seeking a Senior Director / Executive Director of Clinical Development who will provide strategic and tactical medical leadership and oversight of clinical oncology studies, including engagement with academic and partner investigators, while ensuring compliance of all relevant regulatory guidelines.
Reporting to Kinnate’s SVP Clinical Development, the incumbent will advance Kinnate’s lead compounds, as single agents or in rational combinations, into clinical trials of cancer patients with a range of solid tumors. The successful candidate will have a passion for novel science, an affinity for strategic thinking, an aptitude for looking beyond the day-to-day execution, and a record of leading early-stage and mid-stage clinical programs to critical milestones.
This person will provide key overall clinical and scientific leadership to clinical development programs while ensuring compliance with regulatory requirements and standard procedures. The ideal candidate should have experience working in a fast-paced dynamic environment.
· Clinical/Medical leadership of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory and health authority requirements
· Partner with SVP Clinical Development in creation of and revisions to Kinnate’s Clinical Development Plan (CDP)
· Author and/or review clinical documents required for the conduct of clinical studies, including clinical protocols (and amendments), informed consent documents, investigator brochures, and safety management plans in compliance with regulations and good clinical practices
· Assist in preparation of clinical sections of key regulatory documents, including INDs, IBs, annual safety reports and briefing packages, and lead clinical engagement with IRBs and Ethics committees
· Provide clinical leadership in clinical study and program teams, and lead clinical communication to upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and presenting a plan of action for resolution of issue
· Prepare presentation materials for internal and external meetings, such as clinical team meetings, Scientific and Clinical Advisory Boards, and Board of Director Meetings
· Lead ongoing data review, analysis, and interpretation to understand safety and efficacy profile of the investigational drugs
· Contribute to authoring and presentation of abstracts, posters, and oral presentations for scientific and clinical meetings
· Collaborate with SVP Clinical Development, Clinical Scientist, and Clinical Operations group to identify and qualify global study sites and build strong professional relationships with study investigators
· Present aspects of clinical program at Site Initiation Visits, Investigator's Meetings and scientific conferences
· Serve as the first medical point of contact with sites: answer site questions about patient eligibility, enrollment, and provide clinical input into patient safety assessment and management
· Review and assist creation of data analysis plans, case report forms (CRFs), study reference manuals, laboratory and biomarker manuals, patient diaries, and drug accountability forms
· Review project specifications for IRT/IXRS, ePRO, Imaging Charter for Central radiology review and other procedural documents
· Participate in ongoing clinical data cleaning and review and contribute to clinical study report drafting and/or review
· Manage a portfolio of one or more clinical programs (or programs transitioning to the clinic), either individually or together with direct report(s).
· Work together with the Clinical Scientist to ensure that above responsibilities are smoothly and efficiently carried out, to facilitate open, transparent communication both within the Kinnate team and with appropriate external partners, and to provide clinical expertise and support as needed to other line functions.
The Right Stuff
· Medical Doctor (M.D.) - with Board Certification in Medical Oncology highly preferred
· Minimum of 5-10 years of clinical development experience in the pharmaceutical or biotechnology industries with at least 3 years involvement in oncology drug development
· Early Phase (Phase 1 and 2) oncology clinical trial experience, with emphasis on serving as the medical leader for trial programs.
· Thorough working knowledge of clinical trial design, methodology, and statistical concepts
· In-depth knowledge of GCP/ICH guidelines
· Working knowledge of the IND/NDA process is strongly preferred
· Proven ability to provide leadership and positively influence diverse stakeholder groups across cross-functional teams, study investigators, key opinion leaders and the medical and scientific community
· Available for periodic travel including domestic US and internationally as 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.
· Based in San Diego or San Francisco highly preferred
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 $286,000 to $315,000. 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
· 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 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.