Sr Director, Clinical Development (MD)

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

Everyone at Kite is grounded by one common goal curing cancer. Every single day we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission

As a Senior Medical Director you will provide clinical oversight to multiple clinical trials. Additionally the Senior 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.

Job Responsibilities

• Provides ongoing medical monitoring for multiple clinical trials including assessment of eligibility criteria toxicity management and drug safety surveillance.

• Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.

• 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.

Basic Qualifications

• MD/DO and 6 years of clinical scientific and/or drug development experience in the biopharma industry healthcare consulting academia

Preferred Qualifications

• Board certification/specialization in hematology or oncology

• CAR-T therapeutic area experience

• Multiple myeloma disease area expertise with experience managing Phase II or III studies experience in multiple myeloma CAR-T trials within the pharmaceutical industry.

• Drug development experience either within industry or as a clinical investigator/physician scientist in academia or equivalent experience; drug development experience in hematology or oncology.

• Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.

• Ability to think analytically and strategically to formulate develop and execute clinical plans.

• Strong leadership skills with an ability to set vision lead change and mentor others.

• Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful open and honest dialogue and to foster a robust sharing of ideas and creative problem solving.

• Excellent scientific written and oral communication skills.

• Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design study conduct and interpretation of clinical results.

• Well-developed sense of integrity strong work ethic scrupulous attention to detail clear ability to establish and maintain timelines and persistent commitment to ensuring a high level of quality.

• Ability to travel domestically and internationally to company scientific regulatory investigator and other meetings (20-30% travel expected).

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals purpose and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us

For additional benefits information visit:

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 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:

Gilead Sciences Inc. 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 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 contact for assistance.

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