Sr Clinical Development Scientist

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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

As part of the Clinical Development Department the Sr Clinical Development Scientistfills a key role (Clinical Scientist) on the clinical study team within one of Kites cellular therapy programs. Working in close collaboration with the study medical monitor the incumbent will provide scientific guidance and support to the team. He or she will be responsible for various aspects of clinical study execution including protocol writing building study infrastructure staff training data cleaning/analysis investigator interaction and support of regulatory filings.

Essential Duties and Job Functions:

Integrates scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered high quality studies.

Acquires and utilizes knowledge of clinical trial design and relevant disease indications to assist with protocol development. Participates in discussions concerning scientific and procedural aspects of study design. Coordinates with other departments to produce the final protocol and informed consent documents.

Contributes to the development of CRFs edit checks IVRS specifications ongoing data cleaning (query generation coding review SAE reconciliation) and data trend analysis.

Designs patient profiles and writes accompanying medical data review rules as directed by the medical monitor.

Leads data cleaning effort in preparation for dose escalation or DSMB meetings as applicable to study stage.

Organizes and manages external medical advisory committees for the study team such Scientific Steering Committees as directed by the medical monitor.

Researches and summarizes scientific or technical information available in published literature for continual self-learning and to assist in preparing training study manual or investigator meeting materials.

Participates in the review of statistical analysis plans table listing figure design and presentations of study data.

Addresses site questions regarding protocol and related scientific issues and attends site initiation visits (SIVs).

Assists in reviewing briefing books health authority requests for information IND annual reports Investigator Brochures and other regulatory documents.

Supports priorities within the functional area and contributes to department initiatives as requested.

BASIC QUALIFICATIONS:

BS/BA in biomedical field and 8 years relevant scientific and/or drug development experience -OR-

MS in biomedical field and 6 years relevant scientific and/or drug development experience -OR-

PhD or PharmD and 2 years relevant scientific and/or drug development experience

PREFERRED QUALIFICATIONS:

Advanced degree (PharmD PhD MS etc.).

Ideally the candidate will have experience directly in the clinical science role in a hematology/oncology indication and on global phase 2 and 3 studies.

Able to translate technical concepts into accessible language and direction for the broader study team.

Flexible and adaptable to quickly changing priorities and willingness to move between projects to provide support/expertise as business needs dictate.

Experienced in Microsoft Office (Excel Word PowerPoint OneNote) and ideally also with job related programs such as J-Review and Medidata Rave or similar.

Strong understanding of ICH GCP as well as general knowledge of industry practices and standards.

Excellent interpersonal organizational written and verbal communication skills.

Ability to work effectively on teams with a combination of remote and office-based team members.

Exemplify our core values of integrity accountability teamwork excellence and inclusion.

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at 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 individuals 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:

Please apply via the Internal Career Opportunities portal in Workday.