POSITION OVERVIEW:
You will play a supportive role in late stage oncology clinical development. Working in collaboration with the Clinical Scientist 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.
EXAMPLE 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 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.
Basic Qualifications:
Bachelor's Degree and Six Years' Experience
OR
Masters' Degree and Four Years' Experience
Preferred qualifications:
- PharmD or PhD in clinical research or clinical pharmacology.
- 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.
- 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 travel.
People Leader Accountabilities:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
