Sr Clinical Development Scientist

1110 Kite Pharma, Inc.; Greater London; On-site; GBP 65,000 - 100,000; Full time

Job summary

Kite Pharma, Inc. specializes in innovative cancer immunotherapies and collaborates on late-stage oncology trials. This role supports clinical development, protocol execution, data analysis, and regulatory filings in CAR-T programs.

The candidate will work with a cross-functional team to design studies, prepare documentation, and ensure compliance with GCP/ICH guidelines while advancing novel therapies for patients with cancer.

Qualifications

• Typically requires PharmD or PhD in clinical research or clinical pharmacology.
• MS with 6+ years relevant scientific and/or drug development experience.
• BS or RN with 8+ years relevant scientific and/or drug development experience.

Responsibilities

• Acquires and uses knowledge of clinical trial design to develop study concept sheets and protocols.
• Participates in protocol review discussions concerning scientific and procedural aspects of study design.
• Prepares study protocols, amendments, sections of study manuals and Investigator meeting notebooks with guidance.
• With supervision, contributes to design and development of CRFs, Data Management Manuals and Data Analysis Plans.
• Addresses questions regarding scientific and procedural issues from Investigators with supervision.
• Contributes to preparation/review of data listings, summary tables, study results, manuscripts, and scientific presentations.
• Assists in preparation/review of regulatory documents.
• Anticipates obstacles within a clinical study and with guidance implements solutions.
• May coordinate teams and provide direction.
• May provide clinical monitoring for one or more clinical studies or components of larger studies.
• Must summarize scientific information from literature to integrate into new study development.

Skills

Fast learner

Adaptable to change

Analytical abilities

Strong communication

Understanding of drug development

Regulatory knowledge

Education

PharmD or PhD in clinical research or clinical pharmacology

MS with 6+ years relevant scientific/drug development experience

BS or RN with 8+ years relevant scientific/drug development experience

Tools

Microsoft Office

Job description

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 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.

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.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.