Director, Clinical Operations, Site Engagement & Patient Advocacy

Position Summary:

The Director of Site Engagement and Patient Advocacy is the lead representative of Apellis developing recruitment strategies for our clinical studies, supporting investigator sites and study teams by maintaining site relations/site staff engagement, and partnering with cross-functional stakeholders to define the company’s patient advocacy priorities, as well as, overseeing advocacy strategies and collaborations that educate and activate patients. As a key member of the Clinical Operations team, they will be responsible for the management of clinical sites being evaluated and/or participating in Apellis clinical trials, including site feasibility and study enrollment. Through their partnership with clinical study teams, they will ensure successful execution of the enrollment strategies and improve the overall experience for patients, sites, and site staff.

Key Responsibilities Include:

• Communicate directly with sites to enable start-up and maintain active collaboration with sites during maintenance and close-out, driving a superior customer experience.
• Apply regional expertise to oversee investigator site start-up activities to ensure timelines are met, including site identification and qualification, facilitate negotiation and execution of clinical trial agreements, site training and participate in site initiation visits.
• Identify potential opportunities to accelerate clinical trial enrollment and effectively drive timelines aligned with company priorities.
• Build unique enrollment strategies in partnership with clinical study leads that align with the clinical program milestones/objectives.
• Ensure execution of strategies to maximize enrollment across the clinical study portfolio, leveraging lessons learned from regional engagements and different therapeutic areas.
• Responsible for monitoring site and country level enrollment metrics to proactively identify risks/issues and propose mitigations.
• Create and execute a strategic and tactical advocacy plan and corresponding budget.
• Successfully engage rare disease advocates, building trust and long-term relationships.
• Establish and maintain key relationships with advocacy organizations to drive initiatives for collaboration and education. Share information on company activities and interests with advocacy organizations as appropriate.
• Identify key strategic company representation and advocacy activities at patient conferences and meetings.
• Serve as the communication bridge between sites, vendors and Apellis trial management team.
• Collaborate with cross-functional internal and external study teams to remove barriers to trial execution at a site and/or country level.
• Establish and develop strong professional relationships with clinical investigators, study coordinators and other site staff to expand/maintain clinical research partnership opportunities and optimize delivery of clinical trials.
• Support identification and development of clinical research naïve sites, through training and supporting development of processes to conduct clinical research.
• Create institutional knowledge and libraries of country specific requirements for future reference.
• Additional local responsibilities as required and appropriate for the local region.
• Frequent travel in assigned regions, with up to 50% or higher domestic and/or international travel.

Education, Registration & Certification:

• Bachelor’s degree or equivalent in Science/Health Care related field; advanced degree preferred but not required.

Experience:

• 10+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization.
• 6+ years' operational experience in clinical research, with direct exposure to clinical trial site management and engagement in the assigned region.

Skills, Knowledge & Abilities:

• Strong understanding and knowledge of regional clinical research landscape, guidelines and regulations.
• Strong verbal and written communication skills.
• Demonstrated interpersonal skill set necessary to guide and maintain internal and external collaborator relationships.
• Challenge the norm with creative solutions.
• Ability to work in a fast-paced environment.
• Ability to prioritize and manage multiple competing tasks and demands while ensuring overall quality and integrity.
• Foster open and transparent communication.
• Demonstrated ability to effectively influence and implement change and continuous improvement.
• Collaborate effectively in a dynamic, cross-functional matrix environment.

Physical Demands and Work Environment:

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