Senior Clinical Development Scientist

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. Join Kite as we make even bigger advances in cancer therapies and help shape the future of medical science.

We believe every employee deserves a great leader. People Leaders are the cornerstone of the employee experience at 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 fulfill their aspirations.

About the role

You will play a supportive role in late-stage oncology clinical development. Working in collaboration with the Clinical Scientist Program Lead, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include collaboration on functional area tasks during program implementation, clinical study start-up, execution, close-out, data analysis/reporting, and support of regulatory filings.

Responsibilities

• Acquire and use knowledge of clinical trial design to develop specific study concept sheets and protocols.
• Participate in protocol review discussions concerning scientific and procedural aspects of study design.
• Prepare study protocols, amendments, specific sections of study manuals, Investigator meeting notebooks, and other documents as needed with guidance and supervision.
• Contribute to the design and development of CRFs, Data Management Manuals, and Data Analysis Plans with supervision.
• Address questions regarding scientific and related procedural issues from Investigators with supervision.
• Contribute to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
• Assist in the preparation/review of regulatory documents.
• Anticipate moderately complex obstacles within a clinical study and, with guidance, implement solutions.
• May coordinate teams and provide direction.
• May provide clinical monitoring for one or more clinical studies or components of larger studies.
• Enter a new therapeutic area and summarize scientific information from published literature to integrate into new study development.
• Adhere to regulatory requirements of study conduct, industry standards of Good Clinical Practice, and Gilead SOPs.

Requirements

• PharmD or PhD in clinical research or clinical pharmacology with scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
• MS with 6+ years’ relevant scientific and/or drug development experience.
• BS or RN with 8+ years’ relevant scientific and/or drug development experience.
• Relevant experience in Multiple Myeloma and/or CAR-T Therapy is preferred.
• Proficiency with Microsoft Office and other job-related programs.

Qualifications

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, moving between projects easily and providing support/expertise where needed.
• Proven analytical abilities as demonstrated through past experience and/or academic research.
• Understanding of drug development phases and the nature of associated clinical trials across phases.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP, and familiarity with standard clinical procedures.
• Strong communication and organizational skills.
• Ability to travel when needed.

People Leader Accountabilities

• Create Inclusion: Model inclusion and embed the value of diversity in team management.
• Develop Talent: Understand the skills, experience, aspirations, and potential of employees; coach them on current performance and future potential.
• Empower Teams: Align team goals, purpose, and organizational objectives; provide support to remove barriers and connect the team to the broader ecosystem.

Pay

The salary range for this position is:

• Other US Locations: $153,935.00 - $199,210.00
• Bay Area: $169,320.00 - $219,120.00

Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. Actual compensation will vary.

Benefits

• This position may be eligible for a discretionary annual bonus and discretionary stock-based long-term incentives (eligibility may vary based on role).
• Paid time off.
• Company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: Gilead Careers - Compensation, Benefits, and Wellbeing.