Kinnate Biopharma is driven by the urgency of cancer patients who need more effective therapies. We utilize our deep expertise in structure-based drug discovery, translational research and patient-driven precision medicine, which we refer to as our Kinnate Discovery Engine, to develop targeted therapies. Our lead programs include candidates in preclinical development for cancers that are driven by specific oncogenic alterations in either the BRAF kinase gene, or in the FGFR2 and FGFR3 kinase genes. To help move our programs forward, Kinnate has brought together a management team of precision oncology experts and scientific advisors who publish widely-cited research on topics relevant to the study and treatment of cancer and lead clinical units at experienced precision medicine cancer centers in the United States.
Your impact at Kinnate
We are seeking a Senior Medical Director 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 Senior Medical Director 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.
The Senior Medical Director 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. or equivalent) with Board Certification in Medical Oncology
- Minimum of 5 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 is strongly preferred, 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 preferred, other locations considered.
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.