Advisor-Clinical Development Oncology
The Clinical Development Organization, a division of Lilly Research Laboratories, partners with colleagues in Research, Oncology, Biomedicines, and Diabetes to effectively and efficiently design, plan, and execute clinical trials across all phases of research. Uniting authorities in clinical development and design, laboratory and data sciences, site engagement, and trial capabilities, we focuses on patients, participants, and regulators to deliver novel designs and innovative research approaches. We focus on excellence in bringing these capabilities together and providing diverse career opportunities within global clinical development has established Lilly as an industry leader in bringing new medicines to patients.
Ensuring the effective and efficient delivery of asset clinical development programs that meet the goals and objectives of the asset strategy and profiles are critical. To make this process success, we are seeking a Clinical Development Advisor. In this role, you will act as a single point of accountability for cross-functional clinical development of assets and/or programs. If you are experienced delivering high quality clinical plans that enable efficient execution, proactively manage risk, and finding opportunities to accelerate clinical development, we have the role for you.
As an Advisor in the Clinical Development Organization, we will rely on your expertise to ensure support of key clinical deliverables in support of submission, inspections and publication. You will effectively mentor, develop, and retain a diverse Clinical Trial Project Management team and staff.
This role is an exciting opportunity to collaborate with asset teams to build bold asset profiles and to partner with our Design Hub to craft viable clinical scenarios. You will work to deliver complete clinical trial packages that enable rapid transition into trial execution. Ideally, you will:
- Identify and support novel development approaches to accelerate asset development
- Champion development of the asset strategy and translate to the clinical plan across Clinical Trial Management staff
- Demonstrate strong business insight, problem solving and agility to help the team adjust to changes.
You will maintain risk plans during trial implementation in response to new data. To successfully accomplish this task, you will promote broad collaborations. You will account for budget planning, monitoring, and control of the clinical plan/budget. You will also:
- Represent clinical execution/delivery function at core team meeting ensuring efficient and streamlined processes.
- Document and communicate effectively appropriate information as needed.
It is key that you nurture a culture of innovation and inclusion. You will engage in continuous improvement across areas such as clinical development, complete trial packages, and process improvement. You will actively engage in project prioritization and state of inspection readiness.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
- Bachelor degree, preferably in a scientific or health-related field
- Minimum of 8 years experience in the pharmaceutical industry and/or clinical research
- 2 years supervisory experience
- Prior experience in leading complex/cross-functional projects, and/or clinical trials
- Experience with managing development budgets.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this
- Deep understanding of the pharmaceutical drug/device development process
- Post-graduate degree, e.g., Pharm D, M.S., or Ph.D.
- A strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
- Ability to take and defend tough/unpopular positions
- Prior project management experience and/or experience leading with multi-disciplinary team
- Demonstrated ability to translate strategic knowledge and effectively influence the direction of daily operations
- Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.