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.
Your impact at Kinnate
As the Director, Clinical Pharmacology you will be a critical member of our cross-functional teams contributing to the design & execution of clinical studies within Kinnate’s clinical programs. Your contributions will be foundational to the safe, efficient, and compliant development of our next-generation targeted oncology therapies in early phase & advanced human clinical trials.
· This is not a standard clinical pharmacology leadership role. This role is highly visible and significantly impacts our patients and company. We are on a critical mission to bring innovative, effective solutions to patients at a fraction of the price. This role will help us drive towards that pinnacle goal of truly putting patients first.
· You will provide strategic clinical pharmacology guidance to functional project teams and will support senior management in the selection of action plans that best meet clinical pharmacology and drug development business objectives at Kinnate. You will be responsible for driving the strategy, planning, design, and execution of clinical pharmacology studies and for working cross-functionally to optimize clinical interventional protocols. You will review external data, lead the analysis, interpret, and report clinical pharmacokinetic and pharmacodynamic data on Kinnate compounds.
· You will develop clinical pharmacology plans (e.g., pharmacokinetics, pharmacodynamics assessments, population PK, exposure-response and other modeling and simulation approaches) to support the development and fast registration of Kinnate products. This includes conducting risk assessments to anticipate potential issues, leading issue resolution efforts, and developing contingency plans if needed.
· You will oversee clinical study conduct, collaborating with clinical operations, data management, and biostatistics, and monitor our work with CROs/external vendors to ensure compliance with agreed protocols, quality standards and timelines.
· You will co-author regulatory submission documents (e.g., CTD, Investigator brochure (IB), EOP2 meetings, IND/NDAs, MAAs and pediatric plans), and will anticipate and support preparation of responses to regulatory questions by the teams.
· You will leverage your understanding of oncology drug development and your pro-active and highly developed communication skills to bring our innovative medicines to cancer patients.
· You will maintain up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software and will maintain a thorough and in-depth knowledge of PK/PD and drug development literature across oncology and other relevant therapeutic areas.
· As a young and growing organization, we encourage you to develop and implement new clinical pharmacology tools and technologies to drive smarter drug development for our programs and, more broadly, to identify and develop process improvement initiatives as needed. From time to time, you may need to provide clinical pharmacology training to educate our staff, both clinical and nonclinical.
New oncology therapy breakthroughs await your creative spirit and “roll-up your sleeves” approach because #patientsarewaiting!
The Right Stuff
· You have a PhD with 10+ years of experience or Pharm D with 11+ years of experience in a relevant field (i.e., experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters). Regardless of degree, you should have:
· Strong knowledge of pharmacokinetics and pharmacodynamics principles, modelling and simulation, Model-Informed Drug Development, ADME concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
· Proficiency and experience in using common PK/PD modeling software packages (such as Phoenix WinNonlin, NONMEM, R, SAS, and/or other similar tools).
· A balance of large pharma and biopharma experience (i.e., at least 10 years of experience in oncology R&D settings, much of which includes biopharma).
· You have a deep & sophisticated understanding of oncology drug development from pre-IND phases thru to early phase & late phase clinical development.
· You have a deep working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations
· You have outstanding written & oral communication skills and presentation skills that enables clear messaging and drives programs forward
· You are recognized as a leader and have a track record of building strong collaborative partnership with diverse cross-functional team members & external partners
· You are passionately committed to bring innovative oncology drugs to patients to drive better clinical outcomes.
· You critically analyze problems and provide creative solutions
· You have the confidence and discipline to work autonomously
· You have genuine curiosity and a drive to ask questions (e.g., looking for the 'why' of every project)
· You have a strong desire to strive for continuous improvement and are a “self-starter”
Kinnate Biopharma Inc. recently closed our $276M initial public offering 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 the San Francisco Bay Area. 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.
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.