Associate Director, Clinical Development Trial Lead (CDTL)

Job Description

Job 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 Product 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.

Duties and Responsibilities:

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 Client 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.

Highly Desired Skills:

• Experience with oncology (early & late phase clinical trials).
• 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.