Sr Clinical Development Scientist

Description

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, 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:

· Acquires and uses knowledge of clinical trial design to develop specific study concept sheets and protocols.

· Participates in protocol review discussions concerning scientific and procedural aspects of study design.

· Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with guidance and supervision.

· With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.

· With supervision, addresses questions regarding scientific and related procedural issues from Investigators.

· With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.

· Assists in the preparation/review of regulatory documents.

· Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.

· May be asked to coordinate teams and provide direction.

· May provide clinical monitoring for one or more clinical studies or components of larger studies.

· Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.

· Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

· Typically requires a 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.

· Experienced with Microsoft Office and other job-related programs.

Knowledge & Other Requirements

· Demonstrated ability to be a fast learner.

· Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

· Proven analytical abilities as demonstrated through past experience and/or academic research.

· Understands 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.

· When needed, ability to tr

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.