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 Vice President of Clinical Development who will provide strategic and tactical medical leadership of the clinical development group – including clinical operations. Also including oversight of clinical strategy and planning, investigator engagement, and functional leadership of the Clinical Scientist and Global Clinical Lead roles.
Reporting to Kinnate’s Chief Medical Officer, the SVP Clin Dev 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.
S/he 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.
Responsibilities
Provide 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.
Manage the growth and operations of the Clinical Development function and career development of direct reports.
Clinical/Medical oversight of global clinical strategy and 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.
Lead the creation and revisions of the Clinical Development Plan (CDP).
Oversee Kinnate’s portfolio of clinical programs and programs transitioning to the clinic.
This includes accountability for:
o Creation of clinical documents required for the conduct of the clinical development program and studies,
o Preparation of clinical sections of key regulatory documents and leadership of clinical engagement with IRBs, Ethics committees, and oversight of clinical engagement with regulatory authorities,
o Management of the presentation strategy for scientific and clinical meetings, other pertinent external meetings, and designated internal meetings,
o Clinical leadership in clinical study and program teams, and of clinical communication to upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and development/presentation of a plan of action for resolution of issues,
o Data monitoring and review, analysis, and interpretation to understand safety and efficacy profile of the investigational drugs,
o Assessing the significance of, and integrate, emerging data from clinical pharmacology studies and investigations into the CDP and study protocols (in conjunction with the Clinical Pharmacology group),
o Together with Clinical Operations and Data Management, creation of data analysis plans, case report forms (CRFs), study reference manuals, laboratory and biomarker manuals, patient diaries, and drug accountability forms,
o Together with Medical Affairs develop relationships with KOLs and support investigator engagement
o Together with Clinical Operations, development of project specifications for IRT/IXRS, ePRO, Imaging Charter for Central radiology review and other procedural documents,
· Collaborate with CMO and other Senior Leadership Team members to identify and qualify global study sites and build strong professional relationships with study investigators. Also serve as escalation point in discussions with sites and study investigators as needed.
· Collaborate with the Safety (both Nonclinical and Clinical) functions to ensure a smooth working relationship between Safety and Clinical and to support creation of the clinical safety reporting and assessment framework.
· Collaborate with CMO and other Senior Leadership Team members to identify and close gaps in policy, procedures, and infrastructure for Kinnate’s clinical development function, and take ownership of organizational development initiatives as agreed upon with CMO
· Collaborate with the Director of Patient Advocacy and external consultants to support and advance the patient engagement strategy initiative at Kinnate.
· Manage the Clinical Scientists and Global Clinical Leads 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); Board Certification in Medical Oncology preferred.
· Minimum of 10 years of clinical development experience in the pharmaceutical or biotechnology industries with at least 5 years involvement in oncology drug development.
· Early Phase (Phase 1 and 2) oncology clinical trial experience is strongly preferred, with emphasis on experience serving as the medical leader for trials and programs. Direct experience with global programs is a necessity.
· Thorough working knowledge of clinical trial design, methodology, and statistical concepts.
· Thorough working knowledge of clinical pharmacology; formal training is a plus.
· In-depth knowledge of GCP/ICH guidelines.
· Working knowledge of the IND/NDA process is strongly preferred. Direct experience with NDA filings is a plus.
· An understanding of how commercial, business, and scientific/clinical considerations come together to create successful products 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.
Fit with Kinnate culture:
· Ability to build strong relationships with co-workers of various backgrounds and expertis’
· 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 $390,000 to $435,000. 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 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.