Executive Director, Clinical Development
Kura Oncology
Job highlights
Summary
Join Kura Oncology, a leading biotech company focused on precision medicine for cancer treatment, as a Senior/Executive Director, Clinical Development (MD). Lead cross-functional teams in designing and conducting oncology clinical studies, particularly within the FTI franchise. Ensure scientific rigor and innovative development strategies. Collaborate with various departments, including clinical operations, biostatistics, and translational medicine. Serve as Medical Monitor for clinical research and represent Kura to external organizations. Manage clinical regulatory deliverables and analyze clinical data, including safety monitoring. This role requires a minimum of 3 years of relevant experience, an MD or PhD, and proven clinical research skills. Kura offers a competitive compensation package, including generous benefits, equity, and a bonus.
Requirements
- Minimum of 3 years of relevant experience in drug development either in industry (preferred) or in academia
- M.D. or Ph.D. degree required
- Proven track record of strong clinical research skills, including publications
- Ability to partner with others to implement innovative development strategies
- Demonstrated excellence in independently leading and conducting research and ability to evaluate, interpret and present complex scientific data
- Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concepts into layman's terms
- Strong attention to detail with ability to understand the broader picture and priorities
- Must be a dedicated self-starter with a high energy level and ability to achieve results
- Must have strong communication and leadership skills-the ability to influence and work successfully with colleagues, customers, and corporate partners
- The candidate should have experience in handling multiple projects at a time
Responsibilities
- Lead cross-functional clinical teams for the design and conduct of oncology studies, specifically with the FTI franchise
- Ensure that scientific rigor and innovation drives Kura Oncology’s development strategies
- Ensure excellence in both strategy and execution by partnering closely with colleagues in clinical operations, biostatistics, data management, program management and translational medicine
- Serve as Medical Monitor of sponsored clinical research and as medical representative to CROs, reference laboratories and other organizations involved in the execution of clinical trials
- Responsible for of all clinical regulatory deliverables and other clinical documents associated with the clinical trials under his/her direct responsibility, including protocols, and the clinical portion of INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s and clinical expert reports, among others
- Responsible for the analysis of clinical data, including safety monitoring in collaboration with PV
- Participate in site initiation visits and other site visits at clinical center
Preferred Qualifications
Experience in precision oncology/hematology preferred
Benefits
- 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!
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