Note: The job is a remote job and is open to candidates in USA. Binding Minds Inc. is a Certified Disability Owned Business Enterprise seeking an Associate Director, Clinical Development Trial Lead (CDTL) to lead cross-functional study teams in the execution of complex clinical trials. This role is responsible for delivering clinical trial milestones on time and within budget while managing risks and collaborating with various stakeholders.
Responsibilities
- Assume broader responsibilities at the Therapeutic Area, Molecule, and Indication level, including participation in critical chain network builds and providing strategic input
- Apply project management methodologies, processes, and tools to develop and execute local, regional, and global clinical trials
- Understand the scope of work required for successful trial execution
- Monitor trial progress and implement adjustments through appropriate change control processes to achieve trial deliverables
- Develop and track global trial enrollment plans by aligning and integrating inputs across functions and geographies
- Provide consultation and guidance to other CDTLs regarding integrated trial plans
- Assess, identify, and monitor trial-level risks
- Understand cross-functional trial budget components
- Create and monitor grants, non-grants, and budget assumptions using financial tracking tools
- Collaborate with business partners regarding trial budget status and changes
- Serve as a resource for other CDTLs regarding budget-related matters
- Lead, influence, and manage large, complex studies and/or multiple smaller studies
- Partner with other organizations to coordinate and participate in Investigator Study Specific Training (ISSTs) and Affiliate Study Training (ASTs)
- Independently drive local, regional, and global cross-functional study teams through study implementation, execution, and closure
- Empower teams to achieve clinical trial deliverables through proactive issue management, contingency planning, and problem resolution
- Drive solutions across molecules and programs
- Maintain accountability for trial, regional, program, and molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET)
- Partner with Regional Operations to achieve regional enrollment objectives
- Anticipate and resolve complex operational, technical, and business challenges involving study teams, vendors, affiliates, regions, global team members, and business partners
- Identify issues requiring escalation and take appropriate action
- Contribute to continuous improvement initiatives based on industry trends, regulatory developments, and emerging technologies
- Make timely decisions in complex and ambiguous situations
- Manage Third-Party Organization (TPO) qualification, selection, and oversight
- Serve as the Clinical Development point of contact for CROs supporting outsourced and fully outsourced trials and ensure delivery of project milestones
- Demonstrate broad therapeutic, clinical development, and process expertise to influence study design and program-level decisions while considering regional requirements
- Recognize interdependencies among cross-functional activities and understand the impact of decisions on overall trial execution
- Promote expansion of clinical trial process expertise across teams, regions, and external partners
- Maintain knowledge of global and regional operating models and facilitate regional input into study team discussions
- Serve as the single point of accountability for the Trial Master File (TMF), ensuring it remains current and inspection-ready
- Ensure inspection readiness for assigned clinical trials
- Ensure timely documentation of deviations, development of storyboards or issue summary documents, and coaching of CDTLs in these activities
- Anticipate trial and regional issues, identify process gaps, analyze situations, and propose innovative solutions that improve trial delivery while mitigating risks
- Coach peers, new CDTLs, cross-functional team members, and TPOs on clinical trial processes and regional requirements
- Identify and lead process improvement initiatives
- Serve as a Subject Matter Expert (SME) for CDTL peers and support the development and implementation of new tools, processes, and methodologies
- Report, manage, and interpret clinical trial information, ensuring completeness and accuracy across business systems and tools
- Drive regional clinical operational processes and methodologies
- Apply knowledge of global and regional regulations, Good Clinical Practice (GCP), and company standards in clinical trial execution
- Collaborate with affiliates and appropriate resources to understand local regulatory requirements
- Independently identify and resolve quality issues while engaging leadership or other functional experts, including Medical Quality, Legal, and Compliance, when necessary
- Utilize scientific and regulatory knowledge to prepare and provide technical consultation for clinical and regulatory documentation
- Support preparation for meetings with regulatory agencies and assist in drafting responses to questions from regulatory agencies, TPOs, and affiliates
- Integrate scientific, regional, operational, and process expertise to influence clinical trial design, feasibility assessments, and implementation strategies
- Apply clinical development knowledge, critical thinking, and problem-solving skills to support business objectives
- Serve as a resource for Therapeutic Area and disease-state expertise within the clinical team
Skills
- Bachelor's degree (scientific or health-related field preferred)
- 5+ years of clinical research experience or relevant experience in a scientific or health-related field
- Preference for onsite candidates in Stamford, CT or Indianapolis, IN. Remote candidates will also be considered
- Experience in oncology clinical trials, including early- and late-phase studies
- Applied knowledge of project management methodologies, processes, and tools
- Demonstrated ability to lead and collaborate effectively with global colleagues and Third-Party Organizations
- Recognized leadership skills with a proven ability to coach and mentor others
- Ability to lead teams through organizational change while adapting to shifting priorities
- Strong ability to influence without direct authority
- Experience working on cross-functional teams and projects
- Strong relationship-building skills
- Effective communication, organizational, and self-management skills
- Demonstrated success handling complex situations through critical thinking, problem-solving, and navigating ambiguity
- Minimum of 5 years of clinical trial experience with strong knowledge of clinical research processes
- Previous clinical trial site-level or affiliate experience
- Experience with local, country, and regional regulatory requirements
- Strong analytical skills
- Proficiency with project management tools and technologies, including: Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, Power BI
- Ability to travel periodically to scientific and regional meetings
Company Overview