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Executive Director, Clinical Development (MD)…
- Gilead Sciences, Inc. (Santa Monica, CA)
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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
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. Join us in our mission!
We are seeking a highly motivated leader to join us as Executive Director, Clinical Development (MD) – Solid Tumors Lead. This role will play a key role in development and oversight of solid tumor pipeline cell therapy programs, collaboration with external partners, and support search and evaluation opportunities for expanding the pipeline. You will lead a portfolio of clinical trial programs in solid tumors cell therapy clinical development:
+ Accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across the solid tumor portfolio.
+ Lead and direct the development, implementation, and execution of the clinical development strategy, which will include development of the Target Product Profile and Clinical Development Plan.
+ Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations.
Responsibilities:
+ Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products.
+ Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products.
+ Routinely represents the assigned products in cross-functional steering and/or governance committees.
+ Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules/products.
+ Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
+ Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
+ Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations.
+ Presents 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.
+ Develops thought leader and other external relationships that can guide short and long-range clinical development strategies and direction for the disease or therapeutic area overall.
+ Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as internal SOPs.
+ Typically manages a team of direct reports.
Basic Qualifications:
+ MD/DO and 8+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
Preferred Qualifications:
+ Board certification in hematology and/or medical oncology is preferred, including familiarity with clinical oncology.
+ Experience in the biopharma industry is strongly preferred.
+ Experience in submission and approval of INDs and conducting phase 1 studies is strongly preferred.
+ Strong background in translational and pre-clinical sciences is preferred.
+ Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia, including short- and long-range strategic planning, governance, and oversight.
+ Multiple years’ line management (direct reports) experience is preferred.
+ Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
+ Proven track record of achieving or exceeding large-scale, complex short and long-range strategies in life sciences, healthcare, consulting, or academia.
+ Expert-level of knowledge of drug development, as evidenced by proven track record in setting short and long-range drug development strategies and plans.
+ Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
+ Excellent communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.
+ When needed, ability to travel.
Does this sound like you? If so, please apply today!
The salary range for this position is: $317,305.00 - $410,630.00. 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 .
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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 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 [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)
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.
Gilead 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.
Change The World With Us
Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.
While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
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Executive Director, Clinical Development (MD) - Solid Tumors Lead
- Gilead Sciences, Inc. (Santa Monica, CA)