Director, Clinical Development (MD)
El Segundo, CA - USA
Job Summary
Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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:
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:
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 disabilitygenetic 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 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 contact for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT 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. Please apply via the Internal Career Opportunities portal in Workday.
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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Kite Pharma Employees and Contractors:
Required Experience:
Director
About Company
Kite is dedicated to curing cancer. Learn about the science of cell therapy, our cancer research, and our cancer treatments in the pipeline.