Eli Lilly

Associate Director, Clinical Development Trial Lead (CDTL)

Eli Lilly • $122K — $179K *
Stamford, CT 06902In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific or health-related field preferred
  • 5+ years of clinical research experience or relevant experience
  • Authorization to work in the U.S. without sponsorship
  • Onsite work required in Stamford, CT or Indianapolis, IN
  • Experience with oncology and radioligand therapy is highly desired

Responsibilities

  • Lead cross-functional teams in developing and executing complex clinical trials
  • Monitor trial scope, timelines, risks, and budget components
  • Independently drive trial enrollment strategy and execution
  • Identify and resolve operational or business issues within the study teams
  • Ensure inspection readiness and documentation for clinical trials

Benefits

  • Comprehensive benefit program including medical, dental, and vision coverage
  • 401(k) and pension plans
  • Vacation and flexible benefits options
  • Life insurance and employee assistance program
  • Opportunities for professional development and additional training support
Full Job Description
Position Summary:

The Associate Director, Clinical Development Trial Lead (CDTL) independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The Associate Director, CDTL consistently demonstrates independent leadership, influence when working with study teams, management, and business partners, and prospective identification of issues and resolution thereof.

Project Management, and Regional Operational Knowledge
  • Broader responsibilities at Therapeutic Area/ Molecule/Indication level (e.g. attending relative critical chain network builds, providing input on strategy).
  • Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT) as described:
  • Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make adjustments and changes (per change control process) as needed to meet the deliverables of the trial.
  • Timeline - Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies. Provide consultation and guidance to CDTLs on their integrated plans.
  • Risk - Assess, identify and monitor trial-level risks.
  • Budget - Understand the cross-functional, trial-level budget components. Create and monitor the budget grants and non-grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial-level budget status and changes. Function as point of contact for other CDTLs on their clinical team as needed regarding budget items.
  • Lead, influence and project manage large, complex studies and/or multiple smaller studies.
  • Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).
  • Independently drive and influence local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including proactive issue management, contingency planning and issue resolution. Drive to solutions across the molecule/program.
  • Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET)
  • Partner with the Regional Operations to achieve regional enrollment goals.
  • Anticipate and resolve complex and key technical operational or business problems with cross-functional study team (including vendors, affiliates/regions, global team members, and other business partners) with little to no need for direct management support. Evaluate and identify issues that require escalation.
  • Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
  • Use expertise to make timely decisions for ambiguous and complex situations.
  • Manage TPO (third party organization) qualification process, selection, and oversight.
  • Serve as the CRO (Clinical Research Organization) clinical development point of contact for outsourced and fully outsourced trial execution. Ensure CRO delivery of project milestones.


Clinical Trial Process Leadership and Expertise
  • Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise in order to influence study design and program-level decisions considering regional needs.
  • Recognize inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise across functional teams, regions, and external partners and make decisions on process and issues affecting study implementation and execution.
  • Be knowledgeable on the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.
  • Single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is current and inspection ready at all times.
  • Ensure inspection readiness of respective clinical trial(s). Ensures timely documentation of deviations, creation of story boards or issue summary documents (e.g. for high-risk areas/hot topics) and coaches CDTLs in these activities.
  • Network and apply expertise to anticipate trial and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact ability to deliver the clinical trial while reducing and/or mitigating risks, and share process learnings.
  • Contribute to the development of others by acting as a coach for peers as well as new CDTLs, cross-functional team members and TPOs on aspects of CT process and regional specificities.
  • Identify and lead process improvement activities. Acts as a CDTL SME resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as science allows.
  • Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools. Be instrumental in driving regional clinical operational processes and methodologies used.
  • Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.
  • Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g., Medical Quality, Legal, Compliance, etc.) to arrive at the best solution.


Scientific Expertise
  • Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
  • Combine scientific regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.
  • Leverage clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
  • Function as point of contact for Therapeutic Area and/or disease state expertise for others on their clinical team.


Minimum Qualification Requirements:
  • Bachelor's degree (scientific or health-related field preferred)
  • 5+ years clinical research experience or relevant experience in a scientific or health-related field
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1"
  • Candidate will be required to sit onsite at our Stamford, CT or Corporate Center in Indianapolis, IN. Relocation assistance can be provided for qualified candidates.


Highly Desired Skills:
  • Experience with oncology (early phase clinical trial highly preferred)
  • Experience with radioligand therapy (RLT)
  • Applied knowledge of project management methodology, processes and tools
  • Demonstrated ability to lead and work effectively cross-culturally with global colleagues and with TPOs
  • Be recognized as a leader with demonstrated ability to coach others in process expertise.
  • Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities
  • Ability to influence without authority
  • Previous experience working in cross-functional teams/ projects and/or ability to establish and maintain relationships
  • Effective and influential communication, self-management, and organizational skills
  • Demonstrated ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity


Other Information/Additional Preferences:
  • Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
  • Prior clinical trial site-level or affiliate experience
  • Prior experience with local/country regional requirements
  • Strong analytical skills
  • Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI)
  • Need to travel periodically to scientific/regional meetings


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$122,250 - $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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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