Director, Clinical Operations

Location: Natick, MA

Position Summary:

The Director, Clinical Operations will be responsible for planning, implementing, executing and managing clinical studies. A large responsibility will be managing the daily operations of third party vendors in order to achieve project timelines and goals. The Director, Clinical Operations leads the execution and delivery of project activities related to a product or products. The Director will drive tactics and support implementation of departmental and corporate strategy and align within the cross-functional project team.

Responsibilities:

• Accountable for oversight and delivery of project(s) to achieve agreed timelines, scope, quality and budget and in accordance with ICH-GCP and applicable SOPs
• Leads Clinical Operations execution of development strategies for a program or therapeutic areas, and effectively plans, leads, codifies, and evaluates trials across a range of phases and regions
• Serves as primary contact and resource for CRO and vendor personnel as well as team members within Anagram
• Maintains focus on long-term strategy while successfully adapting to changing environmental conditions
• Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact
• Actively contributes to cross-functional discussions on the development strategy for a program or therapeutic area
• Provides timely and accurate input to Clinical Development Plans including timeline forecasting, feasibility assessment for protocol design, resource estimation, and project-level budget
• May lead Clinical Operations efforts in completing relevant sections of document filings
• Writes or oversees writing (in collaboration with technical experts) of clinical trial protocol(s) and amendment(s), Clinical Study Reports (CSR), and reviews all clinical trial-related documents
• Understands Investigational Medicinal Product (IMP) labeling, distribution and clinical supply and projects material forecast with counterparts
• Builds strong relationships with individuals and groups to identify opportunities for sharing of best practices and to align activities and process where appropriate
• Demonstrates solutions-oriented mindset to troubleshoot study-specific procedures, providing guidance to cross-functional subject matter experts
• Monitors budgets for clinical studies, reviews budgets and contracts with CROs, vendors and clinical sites in collaboration with finance
• Leads with business acumen and demonstrates professionalism to support difficult business decisions across the organization
• Manages, supports and directs Clinical Trial Manager(s) and Clinical Trial Associate(s), and acts as escalation level for decision making related to project/program issues or concerns
• Monitors compliance with ICH-GCP and applicable SOPs
• Supports/manages inspection processes and leads planning and implementation of inspection readiness procedures
• Supports and drives a culture that values the importance of process/SOP compliance AND continuous improvement
• Recognizes and manages breaches in GCP, taking appropriate steps to remedy or escalate
• Directs vendor selection, contracting and management, and leads efforts to monitor vendor performance across a range of trials and programs in order to ensure timely delivery of contracted activities for selected vendors as well as oversight with regards to delivery
• Coaches and trains others on drug development lifecycle, trial execution, and GCP concepts
• Monitors and reports on project progress to line manager and other R&D functions as appropriate
• Ensures project team members are appropriately informed/trained on project and project-related issues

Qualifications & Skills:

• Bachelor's degree required; advanced degree preferred; science-related degree preferred
• Minimum of 15 years of clinical operations/development experience with a minimum of 3 years of leadership experience managing cross-functional teams
• Extensive global trial management experience at a CRO or pharmaceutical company
• Demonstrates deep understanding and application of ICH/GCP, EU CTR, and FDA regulations, as well as other GxP regulations in the context of trial execution; understands regulatory environmental changes and impact on trial design and execution
• Has excellent proven track record of achieving results on project objectives, and corporate and departmental goals
• Demonstrates deep understanding of key global regulations that affect program and trial design, and proactively recommends optimizations to program lifecycle management and country participation considering regulatory environment
• Demonstrates exceptional ability to build and maintain strong working relationships in departmental and cross-functional efforts of multiple individuals, work groups or teams to accomplish a project or corporate goals
• Strong people manager with proven track record of leading successful teams
• Strong vendor management skills
• Excellent interpersonal and communication skills, including written, oral communication and presentation skills
• Detail and process-oriented, with excellent project management skills, including risk assessment and contingency planning
• Excellent problem-solving capabilities; solution-oriented
• Ability to travel domestically and internationally as needed
• Able to read, write and speak fluent English

About Us:

Headquartered in Natick, MA, we have all the perks you can find in Cambridge (short distance to lunch, shopping, etc.) and more perks that you can't:

• Ample free parking
• Easy/quick access to Route 9 and Mass Pike (equal distance to Route 495 or Route 95/128)

Anagram Therapeutics offers competitive compensation, including equity, and a comprehensive benefits package that includes medical, dental, short- and long-term disability, AD&D, 401(k) retirement plan, and an Employee Referral Program.

We are an equal employment opportunity employer and do not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

careers@anagramtx.com