Location
London

Hours
Full Time

Salary
Negotiable

About the Role
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.

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 and close out, data analysis and 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 and Investigator meeting notebooks, and other documents as needed with guidance and supervision.
- Contribute with supervision to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
- Address questions regarding scientific and related procedural issues from Investigators with supervision.
- Contribute with supervision 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 implement solutions with guidance.
- May 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 available in published literature to integrate into new study development.
- Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

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.

About you
- 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.

Qualifications
- PharmD, PhD, MS, BS or RN with relevant experience as outlined above.
- Knowledge and experience relevant to oncology clinical development and CAR-T therapies.