Manager, Nonclinical Operations

Research Waltham, Massachusetts


Description

Position Summary:

We are seeking a Nonclinical Operations Manager to help advance the development of our growing pipeline of product candidates. The individual in this position will support all operational aspects of outsourced studies conducted at contract research organizations (CROs) and assist in the oversight of internal nonclinical safety and DMPK/ADME activities. 

Key Responsibilities Include:

  • Responsible for high-level management and operational oversight of nonclinical studies conducted at CROs, including (but not limited to) planning, development, budget and resource tracking, and study- and/or program-specific timelines.
  • Serve as a point person for managing study communications, activities, and documents from Request for Proposal (RFP) to study closure.
  • Work closely with CROs to ensure that all studies are performed in a high quality and timely manner in order to meet program goals and objectives.
  • Critically review study data for content and accuracy, including QC of tables and reports as needed.
  • Contribute to study designs, protocol development, written reports and regulatory submissions, as needed.
  • Collaborate cross-functionally with Research, Clinical, CMC and Regulatory/QA counterparts and relevant program teams, and communicate nonclinical timelines and data to key stakeholders, as needed.
  • Assist with vendor selection, evaluation and qualification including GLP facility and study-specific audits.
  • Assist in coordination of test article logistics and related documentation.
  • Occasional travel (domestic and international, up to 20%) required depending on project or program needs.
  • Other duties as assigned.

Education & Experience:

  • Bachelor’s degree in a scientific discipline (toxicology preferred) with 5-7 years’ experience, or Master’s degree with 3-5 years of relevant experience required.
  • Previous experience in monitoring outsourced studies at CROs highly preferred.
Skills, Knowledge & Abilities:

  • Excellent written, oral and interpersonal communication skills required.
  • Significant experience with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) required; experience with SharePoint and Smartsheet software preferred.
  • Knowledge of global regulatory guidelines (ICH and geography-specific) and FDA GLP standards preferred.
  • Strong attention to detail, with the ability to critically evaluate study-related documentation (e.g., study protocols, interim data, draft/final reports, etc.).
  • Effective organizational skills and ability to work in a small, dynamic, fast-paced environment with frequent course corrections and changing deliverables and timelines.
  • Goal-oriented, highly self-motivated and self-directing individual who works well in a team setting/matrix-type organization preferred.
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.