American Society for Clinical Pharmacology and Therapeutics (ASCPT)

Medical Director, Clinical Development

Spotlight Preferred
Kinnate Biopharma, Inc.
San Francisco, California, United States
13 days ago

Description

Who We Are

We are a dedicated team of professionals who take our work very seriously, but not ourselves too seriously.  We are driven to deliver new medicines to cancer patients who desperately need solutions.  We are a collection of individuals with diverse backgrounds and personalities, yet all united by this purpose to ignite the precision medicine revolution by delivering targeted therapies for those battling cancers. We are motivated by a profound sense of urgency and passion to create medicines with life-saving potential.  If you enjoy co-elevating your colleagues and want to be part of a team of like-minded individuals united by a relentless pursuit to end cancer, then Kinnate may be the home for you.

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 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 the Senior Medical Director, the 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 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.


Responsibilities 

  • 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 Kinnate clinical leadership 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
  • Prepare presentation materials for internal and external meetings, such as clinical team meetings, Scientific and Clinical Advisory Boards, and Board of Director Meetings
  • 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 issues
  • 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 Kinnate clinical leadership, 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 possibly together with direct report(s)
  • Work together with the Clinical Scientist to ensure that above responsibilities are smoothly and efficiently carried out.
  • 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 3 years of clinical development experience in the pharmaceutical or biotechnology industries with at least 2 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.

Kinnate is a science-driven company. We expect every employee to be vaccinated against the COVID19 virus, and we require that vaccination to work in the office.

Kinnate Biopharma Inc. closed a $276M initial public offering in December 2020 and are listed on Nasdaq. Prior to that, we closed three significant venture capital financings, including our $98M Series C round in July and August 2020 and our $74.5M Series B round in December 2019.  Kinnate has a passionate and seasoned Team, guided by industry leaders in precision medicine and drug discovery, developing a focused portfolio strategy, and leveraging unique team expertise.  Our Research and Development team is based primarily in San Diego, California and a portion of our management team is based in San Francisco, California.  We are a small but growing precision oncology company with a bright future.

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. 



Job Information

  • Job ID: 59230333
  • Location:
    San Francisco, California, United States
    San Diego, California, United States
  • Company Name: Kinnate Biopharma, Inc.
  • Position Title: Medical Director, Clinical Development
  • Job Function: Medical Director
  • Setting: Pharmaceutical Company
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: MD
  • Min Experience: 3-5 Years

Please refer to the company's website or job descriptions to learn more about them.

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