You will play a critical role in late-stage inflammatory bowel disease (IBD) clinical development. Working in collaboration with the Clinical Lead for emvistegrast, 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 protocol preparation, start-up/execution/close out, data analysis/reporting and support of regulatory filings and answering questions.
Job 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.
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
Basic Requirements
MS or PharmD or PhD with scientific and/or drug development experience in the biopharma industry, healthcare, consulting.
4+ years’ relevant scientific and/or drug development experience (For Associate director 6+ years of experience).
Relevant experience in immunology/inflammation TA experience is preferred.
Preferred Qualifications
Demonstrated ability to be a fast learner.
Demonstrated ability to work in fast paced environment.
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 globally.
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.
The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States
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