Director, Clinical Development (MD)
Behavioral Health Market Context
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Benefits
Bay Area: $261,375.00 - $338,250.00Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic locationThese considerations mean actual compensation will varyThis position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits packageBenefits include company-sponsored medical, dental, vision, and life insurance plans*2 more items(s)
Qualifications
- •MD/DO and 4+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia
Responsibilities
- •The Medical Director provides clinical oversight to one or more clinical trials
- •Additionally, the Director guides the project teams to design and implement clinical studies at high quality and in a time and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines
- •Provide clinical oversight and medical monitoring to one or more clinical trials
- •Lead project teams to design and implement clinical studies
- •Write protocols, investigator brochures, clinical study reports and review clinical trial documents
- •Conduct investigator meetings and lead site initiation visits with clinical trial investigators
- •Implement and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- •Translate findings from research and nonclinical studies into clinical development opportunities
- •Interact with clinical investigators and thought leaders
- •Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
- •Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner
- •Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
- •Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures
- •Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
- •May present scientific information at scientific conferences as well as clinical study investigator meetings
- •Where applicable, takes a lead on authoring scientific publications
- •May assist in the clinical evaluation of business development opportunities
- •The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together
- •15 more items(s)
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