Director Clinical Development Jobs in Ladera Ranch, CA

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.

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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:

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 company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the'Know Your Rights' poster.

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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday.