Director, Clinical Operations, Site Engagement & Patient Advocacy
Director, Clinical Operations, Site Engagement & Patient Advocacy
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Job Description
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 companys 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 nave 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:
- Bachelors 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:
- This is largely a sedentary role; however some filing is required. This would require the ability to lift files open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers phones photocopiers filing cabinets and fax machines.
Travel Requirements:
- Up to 25% travel expected.
Benefits and Perks:
Apellis offers a comprehensive benefits package including a 401(k) plan with company match inclusive family building benefits flexible time off summer and winter shutdowns paid family leave disability and life insurance and more! Visit to learn more.
Company Background:
Apellis Pharmaceuticals Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information please visit follow us onTwitterandLinkedIn
EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees applicants or any other covered persons because of race color religion creed national origin or ancestry ethnicity sex (including pregnancy) gender (including gender nonconformity and status as a transgender or transsexual individual) age physical or mental disability citizenship past current or prospective service in the uniformed services genetic information marital status AIDS/HIV status smoker/nonsmoker and occupational pneumoconiosis or any other characteristic protected under applicable federal state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance we will consider for employment qualified applicants with arrest and conviction records.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. Duties responsibilities and activities may change at any time with or without notice.
Required Experience:
Director
Employment Type
Full Time
