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 to help shape the future of cancer therapies and medical science.

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 include, but are not limited to, collaboration on functional area activities 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 and review of regulatory documents.
• Anticipate moderately complex obstacles within a clinical study and, with guidance, implement solutions.
• Coordinate teams and provide direction as needed.
• Provide clinical monitoring for one or more clinical studies or components of larger studies.
• Enter new therapeutic areas 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.

Skills

• Demonstrated ability to be a fast learner.
• Flexibility and adaptability to change, moving between projects easily and providing support where needed.
• Proven analytical abilities 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 employees' skills, experience, aspirations, and potential; coach them on current performance and future growth.
• Empower Teams: Align team goals and purpose with organizational objectives, provide support to remove barriers, and hold teams accountable.

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. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.

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