Program Manager

Program Management Waltham, Massachusetts


Description

Description:

 

As a Program Manager at Apellis, the successful candidate will provide strategic leadership and operational expertise in support of various projects having a direct impact on our complex clinical development programs. This role is responsible for liaising  cross functionally on selected programs to coordinate and develop strategies, submissions and compliance activities to facilitate successful outcomes.

 

Job Responsibilities:

  • Coordinate cross functional teams to effectively manage activities and timelines
  • Leverage input from key stakeholders to create integrated development plans that identify key goals, milestones, timeline, risks, assumptions, alternative scenarios, and budgets
  • Foster strong relationships with team members and functional line managers, and serve as key point person for all project-related communication, issue identification, and management
  • Develop and maintain knowledge of US, EU and ROW regulations
  • Perform literature searches and assembling documentation to support project teams
  • Additional duties and responsibilities as required

 

Experience and Background:

  • Degree in a scientific discipline, or equivalent
  • Minimum of 8 years of total pharmaceutical industry experience, including at least 2 years in a project management role
  • Significant experience within the pharmaceutical industry, and strong understanding of all aspects of drug development
  • Knowledge of GMP, GCP, GLP, and ICH guidelines
  • Significant experience across drug development stages from research candidate evaluation to late-stage development; phase III experience preferred
  • Strong leadership skills, including demonstrated ability to lead a cross-functional team, and influence at all levels of an organization.
  • Experience in the application of program management principles and practices
  • Excellent oral and written communication skills, including presentation and facilitation
  • Ability to work independently and with flexibility to handle work flow in a fast-paced environment
  • Some travel will be required, up to 25%

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.