Sr Director, Clinical Development (MD)

Gilead Sciences Inc.; Thousand Oaks (CA); On-site; USD 275,000 - 355,000; Full time

Job summary

Kite Pharma seeks a Senior Medical Director to provide clinical oversight across one or more trials, guiding teams to design and implement studies of high quality within timelines and budgets. This role interfaces with investigators, regulatory affairs, and cross-functional partners to translate research into development plans.

The position requires MD/DO and 6+ years in clinical research or drug development, with neurology specialization preferred.

Qualifications

• MD/DO with 6+ years of clinical research or drug development experience.
• Board certification/specialization in neurology is preferred.
• Experience designing, implementing and conducting clinical trials in neurological diseases is highly desired.

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 site initiation visits with clinical trial investigators.
• Translate findings from research into clinical development opportunities.
• Interact with clinical investigators and thought leaders.
• Work with regulatory affairs and ensure compliance with external guidelines.
• Collaborate across clinical operations, biomarker specialists, CROs, and regulatory affairs.
• Provide input for regulatory filings (e.g., BLA, MAA) and respond to regulatory inquiries.

Skills

Clinical development strategy

Cross-functional leadership

Leadership

Regulatory affairs coordination

Communication with investigators

Education

MD/DO

Neurology board certification

Job description

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 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?

Salary Range

Bay Area: $302,005.00 - $390,830.00.

Other US Locations: $274,550.00 - $355,300.00.

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 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 contact [e-mail] for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR 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.

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: