Head of Global Clinical Operations and Trial Master File

Position Summary:

A unique opportunity to lead Apellis’ high-functioning Clinical Operations and Trial Master File Team. Driving the implementation of key processes to support the organization with inspection readiness activities. Accountable to deliver on the clinical development plans in support of Apellis’ late-stage programs. At Apellis we like to think differently, examine all angles and be open to a different way of working. We are a team that leverages previous experience but encourages innovation and open discussion to drive our decision-making process. Every voice counts at Apellis, and we live by our Values: We Care, We Are Fearless, We Love What We Do, We Are Complement.

Key Responsibilities Include:

• Accountable as a key member of the Development Operations Leadership Team for leading the clinical operations group to partner with our Indication Teams, Clinical Development, Medical Affairs and Translational Organization to drive the clinical operational strategy within a matrix-organization.
• Planning, execution, and management of all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines in close collaborations with key stakeholders, alliance partners and Clinical Research Organizations (CROs).
• Provide oversight and management for all clinical study activities, including clinical budgets; develop contingency plans for clinical trials.
• Establish document standards, requirements, process and reports that allow for the collection and maintenance of clinical trial documents including those aspects outsourced to Contract Research Organization (CRO).
• Participate in the development and implementation of Trial Master File (TMF) standard operating procedures and common work practices within the team.
• Ensure the creation of the Trial Master File plan for each study, creating a template and standard content.
• Provide leadership to an established team of 20+ clinical operations and TMF professionals.
• Manage staffing needs within Clinical Operations to ensure the successful and efficient operation of the department.
• Effectively mentor departmental personnel and support professional development by promoting a work environment that includes coaching, mentoring, accountability, feedback, and high-performance standards.
• Set global work standards, establish clear expectations, and monitor delivery of excellent performance by ensuring that clinical study and operational integrity is maintained to the highest standards, and study practices and methodologies are "state of the art" within Clinical Operations.
• Responsible for oversight of CRO partners and third-party vendors.
• Provide ongoing monitoring of operational issues/risks and remediation measures across portfolio.
• Partner cross-functionally to establish partnerships and strategic direction with external vendors, including functional representation in governance bodies and sponsor oversight for operational strategy, performance, and quality.
• Ensure compliance with internal policies and procedures, GCPs, and applicable regulations; ensure inspection readiness.

Education, Registration & Certification:

• Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.

Experience:

• 12+ years of applicable clinical development and operations experience, ideally with at least 3 years in a leadership role.
• 5+ years of line management experience including management of team members with accountability to therapeutic area indication teams (matrix organization).

Skills, Knowledge & Abilities:

• Global clinical development experience in multiple therapeutic areas, preferably, challenging working-things out for the first time, indications.
• Expert knowledge of global regulatory and compliance requirements for clinical research, local country requirements and ICH GCP, including experience with global regulatory inspections.
• Proven track record of leading and driving business process transformation and organizational change as well as delivering on programs with complex business deliverables.
• Excellent communicator and influencer, able to persuasively convey both ideas and data, verbally and in writing.
• Ability to distill complex issues and ideas down to simple comprehensible terms.
• Ensure that our Apellis values are integrated into the departmental culture and that team members are encouraged to embrace our values.
• Motivate the team by creating an environment of inclusion and collaboration.
• Drive towards innovative solutions and lead decision making by listening to others an