Sr Director, Clinical Development (MD)
$302.01k - $390.83kKite Pharma
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 Senior Medical Director provides clinical oversight to one or more 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
- 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
Basic Qualifications
MD/DO and 6 years of clinical research or drug development experience
Preferred Qualifications
- Board certification/specialization in neurology and experience managing phase 1-3 trials; late stage experience is preferred
- 4 years of relevant drug development experience either within industry or as a clinical investigator/physician scientist in academia or equivalent experience; drug development experience in neurological diseases including neuro autoimmune diseases are highly desired
- Demonstrated clinical development strategist with experience designing implementing and conducting clinical trials with emphasis on proof-of-concept and first-in-human studies
- Strategic leadership and tactical skills excellent initiative and judgment
- Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts including key thought leaders and investigators
- Demonstrated ability to work well in teams in a cross functional manner
- Ability to communicate and work in a self-guided manner with scientific/technical personnel
- Ability to think critically and demonstrated troubleshooting and problem-solving skills
- Self-motivated and willing to accept responsibilities outside of initial job description
- Comfortable in a dynamic small company environment with minimal direction and able to adjust workload based upon changing priorities
- May travel up to 25%
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 Hit apply.
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 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:
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.
For more information about equal employment opportunity protections please view the Know Your Rights poster.
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.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
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