Associate Director - Oncology - Clinical Laboratory Sciences

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.

Associate Director - Oncology - Clinical Laboratory Sciences

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities

The Associate Director - Oncology - Clinical Laboratory Sciences works with business and therapeutic teams to develop clinical lab, diagnostic, and biomarker strategies for trials and compounds. They collaborate on trial design, oversee project management including budgets, timelines, risks, and vendor performance, and require strong expertise in clinical laboratory practices.

•    Engage with Research teams (CDDA, ADME/PK, Toxicology, Biomarker, Companion Dx, Laboratory and Experimental Medicine) at an early stage to establish and document clinical laboratory and diagnostic strategies for both clinical trial protocols and at the molecule level.
•    Shape protocol design for both CLS operations and patient/site requirements
•    Executing clinical and biomarker sampling plans for clinical trials by working with Clinical Laboratory Sciences Associates (CLA’s)
•    Maintain accurate and concise inventory of research and clinical/preclinical samples across drug programs and third-party labs by collaborating with the CLA’s
•    Participate in budget planning activities with CBLDx project managers for clinical trial lab plans and provide precise, integrated cost/time estimates
•    Offer expert consultation with tracking and resolving discrepancies with study team, sites, or CRO vendors within specified time frames
•    Promote knowledge sharing across the organization to enhance clinical design and work towards  improving  existing processes and to implement new and efficient processes
•    Identify key functional capability gaps and proactively address them early enough to accelerate portfolio delivery and deliver to plan 
•    Provide oversight of central labs, CRO’s and data deliverables to support eTMF and DBL’s 
•    Participate in regulatory audits and other for submission elated activities 
•    Serve as a therapeutic and clinical laboratory expert to the CLA’s and provide coaching within the organization that fosters inclusion and innovation, continual improvement, and an external awareness and understanding
 
Minimum Requirements:    

• Bachelor’s degree with at least three years of experience in clinical drug development, preferably in oncology, with a focus on laboratory sciences and diagnostics and a solid scientific background
• 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 Requirements:

• Advanced degree (e.g. MSc, PhD) in a scientific or health care field strongly preferred
• Companion Dx development experience and sample management 
• Experienced in clinical diagnostic and laboratory needs in oncology in a regulated setting
• Demonstrated ability to set and implement strategies and plans to improve complex oncology drug development processes and capabilities.
• Demonstrated analytical, technological, and project management expertise
• Achieves results through cross-functional teamwork and effective communication.
• Proven ability to influence cross functionally without direct authority
• Proven ability to lead development of creative clinical laboratory solutions to address oncology clinical development challenges
• Proven ability to develop diverse organizational talent with next level potential
• Domestic and international travel required (10%), required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$111,000 - $179,300

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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