Sr Clinical Development Scientist

Kite Pharma, Inc.; Santa Monica (CA); On-site; GBP 85,000 - 110,000; Full time

Job summary

Kite Pharma, Inc. seeks a Clinical Scientist to support late-stage oncology programs. You will collaborate with the Clinical Scientist Program Lead on program implementation, start-up/execution/close-out, data analysis and regulatory filings.

You may design studies, prepare manuals and notebooks, and contribute to data listings, manuscripts and regulatory submissions. Regulatory knowledge and strong communication are essential; CAR-T experience is preferred.

Qualifications

• PharmD or PhD in clinical research/pharmacology with drug development experience.
• MS with 6+ years relevant scientific and/or drug development experience.
• BS or RN with 8+ years relevant scientific and/or drug development experience.
• Experience in Multiple Myeloma and/or CAR-T preferred.

Responsibilities

• Acquires and uses knowledge of clinical trial design to develop study concepts and protocols.
• Participates in protocol review discussions on study design.
• Prepares study protocols, amendments, sections of manuals and Investigator notebooks with guidance.
• Contributes to design of CRFs, Data Management Manuals and Data Analysis Plans with supervision.
• Addresses questions from Investigators regarding scientific and procedural issues.
• Contributes to data listings, summary tables, study results, manuscripts and presentations.
• Assists in preparation/review of regulatory documents.
• Anticipates obstacles in a clinical study and implements solutions with guidance.
• May coordinate teams and provide direction; may monitor one or more studies.
• Summarizes scientific information from literature to support new study development.
• Adheres to regulatory requirements and GCP as well as SOPs.

Skills

Fast learner

Flexible

Analytical

Communication

Organizational

Education

PharmD or PhD in clinical research or clinical pharmacology

MS with 6+ years relevant experience

BS or RN with 8+ years relevant experience

Tools

Microsoft Office

Job description

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.