Associate Director/Director, Clinical Pharmacology
Job Description
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.
At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.
As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.
To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.
Essential Job Functions
The Associate Director/Director of Clinical Pharmacology will be responsible for developing, driving, and implementing nonclinical and clinical ADME strategies. You will be a core member of program teams providing ADME perspectives and delivering modeling and analyses necessary to evaluate nonclinical and clinical options, enable plans, and optimize development programs. This includes gap analysis, study design, PKPD analysis and modeling, program assessment, and collaborations to help execute programs. The successful candidate will bring extensive experience in nonclinical and clinical ADME with the ability to work cross-functionally with multifunctional teams to drive programs to success.
- Provides clinical pharmacology leadership on multi-disciplinary teams for oncology programs including modeling & simulation to satisfy world-wide regulatory requirements.
- Provides clinical and nonclinical pharmacokinetic expertise to projects including study design, data analysis and interpretation.
- Develop population PK, exposure-response, mechanistic PK/PD, PBPK and QSP models, as needed, to evaluate risk/benefit and facilitate drug development decisions.
- Experience in developing clinical pharmacology and nonclinical strategy and execute studies such as but not limited to drug-drug interaction studies, specific population, BA/BE, and food effect.
- Provides clinical pharmacology support and leadership in preparation of various regulatory documents including study protocol, CSR, Investigator's Brochure, Clinical Pharmacology section of INDs, CTAs, BLAs and/or NDAs, and clinical pharmacology section of package inserts.
- Participate in meetings with regulatory agencies and respond to regulatory queries.
Job Requirements
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or a closely related discipline with 5+ years of experience for Associate Director or 8+ years of experience for Director in clinical pharmacology, modeling & simulation, drug metabolism and/or pharmacokinetics within a large pharma and / or biotech companies
- Experience with nonclinical and clinical pharmacokinetic protocol design with experience working with CRO's is required.
- Experience in Model Informed Drug Development.
- Strong organizational and time-management skills including the ability to manage several projects simultaneously.
- A strong entrepreneurial spirit and a desire to be hands on.
- Strong analytical and critical thinking skills, and attention to details.
- Demonstrated creativity in problem solving.
- Ability to effectively collaborate as part of cross-functional teams and with research partners.
- Excellent professional interpersonal skills, particularly oral and written communication skills and be able to work in a multidisciplinary team environment.
- Extensive knowledge of regulatory/guidance requirements (i.e. GLP, FDA, EMA) best practices pharmacokinetic/pharmacodynamic testing and risk assessment based on target indication.
The base range for an Associate Director is $178,000- $202,666 and a Director is $216,405 - $251,255 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
Kura's Values that are used for candidate selection and performance assessments:
- We work as one for patients
- We are goal-focused and deliver with excellence
- We are science-driven courageous innovators
- We strive to bring out the best in each other and ourselves
The Kura Package
- Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a variety of plans available with a substantial employer match
- Paid Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.
Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura's website at .
Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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