Director, Patient Feasibility, Enrollment & Retention

Clinical Waltham, Massachusetts


Description

Position Summary:

The Director, Patient Feasibility, Enrollment & Retention will support the strategy and implementation of patient recruitment and retention efforts for our late stage development programs mainly in the rare disease and ophthalmology space.  This is an exciting opportunity that will partner with cross-functional teams and CROs to provide input and guidance regarding recruitment and retention (R&R) vendor engagement, leverage experience to ensure R&R vendors provide sound plans for recruitment and retention of patients. This is the first hire in this position, and presents a unique opportunity to shape and influence this key function within Apellis.

Key Responsibilities Include:        

  • Provide continuity and connectivity between existing program/study feasibility efforts and development of recruitment and retention plans by R&R vendor
  • Support overall study planning by confirming R&R vendor is leveraging feasibility outputs, patient input and other available information when developing patient recruitment and retention strategy
  • Ensure R&R vendor incorporates MOA findings into country-specific recruitment & retention plans
  • Partner with Clinical Operations, Clinical Development, CRO teams, and other key stakeholders to implement innovative recruitment / retention efforts including social, digital, and long-term patient engagement initiatives
  • Identify issues, barriers, etc., preemptively to support successful recruitment and retention of patients and confirm these are addressed by the R&R vendor early in strategy development
  • Direct R&R vendors and team members regarding efficient and timely review of recruitment & retention materials
  • Implement process improvement across the R&R space; provide ongoing assessment and input regarding quality of deliverables and performance of R&R vendors
  • Identify & manage vendor(s) by developing process to support study teams as it relates to the assessment and incorporation of patient input into protocols to influence study design and early operational strategy with the goal of generating data to support executable, patient-friendly study designs and assessments
  • Evaluate opportunities for improvements in study feasibility process across studies
  • Evaluate and champion maximizing efficiency with the Apellis CRO partners to ensure the quality and consistency of logistics.

Education, Registration & Certification:

  • A. or B.Sc. in a scientific discipline; advanced degree preferred

Experience:

  • 7+ years of clinical research / project management experience including clinical site and CRO or sponsor experience
  • Experience in vendor relationship management and governance
  • Experience with rare disease / difficult to recruit populations a plus

Skills, Knowledge & Abilities:

  • Demonstrated success in implementing and supporting new processes in a dynamic environment
  • Proven track record in patient recruitment and retention strategy development, budget planning, and program implementation
  • Comprehensive regulatory knowledge, including ICH and GCPs
  • Knowledge of global clinical trial management in a fast-paced CRO outsourced environment
  • Comfortable working independently with little supervision 
  • Highly organized, results driven, problem solver
  • Superior written and oral communication skills and the ability to work with different levels of management 
  • Highly motivated with the ability to be flexible in a fast-paced environment 
  • Excellent project management skills and ability to effectively juggle multiple ongoing projects to meet deadlines

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 and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

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 pneumocononiosis or any other characteristic protected under applicable federal, state or local law.