Director, Clinical Development (MD)

About this role

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

The Medical Director provides clinical oversight and medical monitoring for one or more clinical trials and contributes to the design and execution of clinical studies in a high-quality, time- and cost-effective manner consistent with departmental goals, regulatory requirements, and resource constraints. This role has meaningful study-level ownership with the opportunity for enterprise-level strategic and organizational leadership visibility.

Job Responsibilities ·       Provide clinical oversight and medical monitoring for one or more clinical trials in neurology and/or autoimmune disease. ·       Contribute to the design and implementation of clinical studies, including early-phase and proof-of-concept trials, in collaboration with senior clinical leaders and cross-functional partners. ·       Draft and/or review protocols, protocol amendments, investigator brochures, clinical study reports, informed consent forms, safety narratives, and other clinical trial documents. ·       Participate in investigator meetings, site engagement activities, and selected site initiation activities with clinical trial investigators. ·       Support execution of clinical development plans by identifying study risks, proposing mitigations, and helping track milestones, deliverables, and budget-conscious study decisions. ·       Interpret findings from research, translational, and nonclinical studies and help translate them into clinical development opportunities. ·       Interact with investigators, key opinion leaders, and other external experts to support protocol development, study conduct, and data interpretation. ·       Partner with internal Regulatory Affairs, Safety, Clinical Operations, Biometrics, Translational Sciences, Medical Writing, and other functions to support high-quality study execution and regulatory compliance. ·       Provide clinical input to regulatory submissions and responses to health authority questions in the context of INDs, clinical trial applications, and later-stage planning. ·       Contribute clinical guidance in interactions with external stakeholders, including advisory boards and patient advocacy organizations, and with internal stakeholders across Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial as appropriate. ·       May present scientific or clinical data at investigator meetings and scientific congresses and may contribute to abstracts, presentations, and publications. ·       May support due diligence or clinical evaluation of external opportunities as needed.

Basic Qualifications ·       MD or DO required. ·       Approximately 2 to 5 years of clinical, scientific, and/or drug development experience in biopharma, academia, healthcare, or related settings. ·       Working knowledge of clinical trial design, protocol development, safety review, and Good Clinical Practice. ·       Ability to function effectively in a matrixed, cross-functional team environment.

Preferred Qualifications ·       Board certified or board eligible in Neurology. ·       Training and clinical expertise in neurology, neuroimmunology, or autoimmune neurologic disease. ·       Drug development experience in neurology, autoimmune disease, cell therapy, immunology, or other advanced therapeutics, either within industry or as a clinical investigator / physician-scientist. ·       Experience supporting Phase 1, Phase 1b/2, or proof-of-concept studies; prior first-in-human exposure is desirable but not required. ·       Demonstrated ability to contribute to study design, study conduct, and emerging data interpretation. ·       Strong clinical judgment, scientific rigor, and problem-solving skills. ·       Effective written and verbal communication skills and the ability to work with appropriate independence while escalating issues thoughtfully. ·       Ability to build productive working relationships with internal colleagues, investigators, and key thought leaders. ·       Comfort operating in a fast-paced and evolving development environment. ·       May travel up to 25%  TBD

The salary range for this position is: Bay Area: $261,375.00 - $338,250.00.   Other US Locations: $237,575.00 - $307,450.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This 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 package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.   For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The c

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