Director / Sr. Director, Clinical Biomarker Development

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 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.

Position Summary:

The Director / Sr. Director, Clinical Biomarker Development will integrate biomarker research and clinical development, and will be accountable for the design, delivery, and execution of biomarker and diagnostics plans in early phase clinical programs. Programs include early proof of concept through registrational studies in a variety of targets. The role involves cross functional collaborations across Biomarker Operations, Clinical Development and Translational Medicine as well as Diagnostic Medical Affairs. Responsibilities encompass strategic planning to optimize the clinical and registrational utility of Biomarker development plans for assigned projects as well as management and career development of biomarker scientists. This person must thrive in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities. 

Responsibilities:

• Oversee the integration of biomarker and diagnostic development plans in clinical development with the current oncology treatment landscape, registrational and launch needs for the asset and with external competitors.
• Ensure individual biomarker scientist plans are developed and implemented optimally according to the strategic needs of the assets and are aligned to company positions and guidelines.
• Create and foster strong strategic partnerships with colleagues that include Biomarker Operations, pre-Clinical Development, Clinical Operations/Development, Dx Regulatory Affairs and Dx Medical Affairs. 
• Apply Biomarker Development strategy to the design and interpretation of clinical trials.
• Provide strategic input into data analysis, and engage in critical thinking, to deliver key data generation and interpretation essential for decision making as well as public scientific disclosure.
• Lead integration with functional teams such as discovery, translational medicine, data science, clinical science etc. to ensure timely analysis, interpretation and disclosure of data to support development of our oncology pipeline.
• Demonstrate substantial and relevant knowledge of scientific and medical literature with genomics and biomarker expertise and its application to strategic drug development and registration.
• Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions. Collaborate with operational teams to ensure cohesive planning and strategy.
• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
• Proactively   generate   ideas   for   improvements   and   take   action   to   solve problems and achieve goals beyond what is required.

Basic Qualifications

• MD or PhD required
• 10+ years of biomarker experience within an academic or industry setting
• 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 employment position

Additional Skills/Preferences

• Strong preferably within laboratory-based cancer research or clinical trials is preferred.
• Clinical   trial   expertise   along   with   experience   in   oncology   with   drug development highly desirable. 
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
• Scientific and analytic ability
• Ability to think strategically and tactically while working effectively in a multifunctional team
• Excellent organization and communication skills
• Proven ability to evaluate, interpret and present complex scientific data to both technical and non-technical audiences.

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