Associate Director / Director Clinical Project Management

Mission

The Associate Director (AD)/Director, Clinical Project Management (CPM) is responsible for the planning, implementation, execution and management of one or more clinical programs/studies. This individual will be a key resource across the organization at all levels for ensuring the successful execution of clinical studies in accordance with AGTC’s corporate goals and objectives.  The individual will provide leadership of cross-functional study teams to ensure studies are conducted on time, within budget and with high quality.  Additionally, the individual will drive vendor oversight activities to ensure the appropriate transfer, accountability and execution of delegated tasks.

Reporting Relationship

• This position will report directly to the Executive Director of Clinical Operations

Duties and Responsibilities

• Direct and manage cross-functional teams in the planning and execution of clinical programs/studies from study start up through close out.
• Represent Clinical Operations on the Product Development Team (PDT); contribute to the product development strategy, provide operational updates and risk analysis, ensure study teams action on PDT decisions.
• In collaboration with internal and external stakeholders, develop, implement, and oversee the clinical operational strategy, including feasibility, timeline, budget and risk mitigation analysis.
• Foster positive and constructive relationships with internal and external stakeholders, including AGTC team members, CROs, vendors, site staff and patient advocacy groups.
• Collaborate with Program Management and Finance to ensure program timelines and budget forecasts are current and accurate.
• Assess actual versus forecasted program timelines, resource requirements and costs, and proactively manage variances and adjustments, as needed.
• Conduct ongoing risk assessment and implement contingency plans, as appropriate.
• Lead and oversee the selection of third-party vendors, including CROs.
• Lead the development and implementation of vendor oversight plans to effectively manage and assess vendor performance to ensure high-quality deliverables.
• Work with internal and external stakeholders to optimize patient recruitment and enrollment strategies.
• Identify and implement opportunities to optimize/enhance processes and or systems to accelerate programs.
• Participate in the authoring, review and finalization of clinical documents such as protocols, informed consent forms, clinical study reports (CSRs), pharmacy and surgical manuals, regulatory submissions and other documents as required.
• Ensure external reporting of clinical studies is current and accurate, e.g. Clinicaltrials.gov.
• Provide regular status reports to senior management as appropriate.
• Ensure studies are conducted in accordance with applicable regulations, GCP guidelines, protocol and affiliated documents and operational strategy.
• Participate in the planning of Quality Assurance activities and oversee the resolution of audit findings.
• Develop and implement plans to ensure inspection readiness and oversee activities in support of GCP audits and regulatory inspections.
• Participate in the development of SOPs and clinical operational systems.
• Work with manager to develop and achieve corporate goals within expected timeframe, ensure goals are set and communicated to direct reports.
• Manage and mentor direct reports.
• Other duties as assigned.
• This job description is subject to change at any time.

Educational Qualifications

• Director: B.S. with minimum ten (10) years or M.S. with minimum eight (8) years of relevant clinical research experience at a Pharmaceutical or Biotech company or CRO. 
• Associate Director: B.S. with minimum seven (7) years or M.S. with minimum five (5) years of relevant clinical research experience at a Pharmaceutical or Biotech company or CRO. 

Additional Qualifications

• In-depth knowledge of all aspects of drug development across Phases 1-IV, including GCP, ICH and FDA regulations
• Self-motivated, flexible, and independent thinker
• Ability to work in a fast-paced/demanding environment
• Problem solver, ability to prioritize and/or multi-task
• Collaborative team member
• Ability to work independently and as part of a team in a fast-paced environment
• Ability to juggle multiple competing tasks and demands
• Proficient in use of Microsoft products (Word, Power Point, Excel, Project)
• Excellent oral and written communication skills
• Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships, including vendors, CROs, etc.
• Strong attention to detail.
• Demonstrated ability to lead, motivate and mentor staff and teams.
• Excellent written and oral communication skills.

Physical Requirements

• Physical demands: (check one)

• Physical activity: (check all that apply)

• Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.)
• Working conditions (indoor/outdoor, noise levels, hazards, working quarters)

Supervisor Responsibilities

Managing and mentoring direct reports