Senior Clinical Research Scientist – Oncology
We want the determined, the big dreamers, the hopeful explorers, the we’ve-got-this-ers. Because those are the kind of people who are best able to make an impact for people with cancer. So, what’s missing? Just someone like you.
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
This position will play a supportive role in Hematology/Oncology clinical development, including programs in immuno-oncology and targeted therapies.
Working in collaboration with the Clinical Research team, the position is responsible for various aspects of ongoing clinical trial program-related activities within the oncology therapeutic area.
These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start-up/execution/closeout, data analysis/reporting, and support of NDA/MAA filings.
Essential Duties and Job Functions:
- Acquires and utilizes 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 appropriate 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, IND annual reports, IND safety reports, Investigator Brochures, and NDAs.
- Supports priorities within the functional area.
- Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
- May be asked to coordinate teams and provide direction.
- May lead two or more specific components of departmental strategic initiatives.
- Must be able to enter a new therapeutic area and summarize scientific information that is available in the published literature to integrate into new study development.
- Excellent verbal and written communication skills and interpersonal skills are required to maintain a working relationship with team members to ensure the scientific integrity of clinical studies.
- May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Knowledge, Experience, and Skills:
- Typically requires a higher degree such as PharmD or Ph.D. in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization, or academic institution
- 6+ years of relevant scientific and/or drug development experience with a BS degree in Biological Sciences, health care, or a related field.
- 5+ years of relevant scientific and/or drug development experience with an MS.
- 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.
- Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire.
We offer a competitive salary and benefits package. Apply today at Senior Clinical Research Scientist – Oncology, Morris Plains, NJ (myworkdayjobs.com)