Associate Director, Clinical Operations – Rare Disease

Clinical Waltham, Massachusetts


Description

Position Summary:

The Associate Director, Clinical Operations will be responsible for the operational management for Apellis’ Rare Disease clinical trials.  As the leader of the program, the successful candidate will maintain oversight, ensure feasibility of trial plans, and pro-actively assess and mitigate risks.  He/she will be accountable for communicating trial status to stakeholders/senior management on a regular basis and escalating issues as appropriate.  This individual will serve as the primary project team representative for Clinical Operations.

Responsibilities:

  • Leads, oversees and aligns activities of the Clinical Operations Team and other functions contributing to the program, in accordance to the program objectives
  • Manage cross functional leadership and CRO/vendor management related to clinical trial operations aspects
  • Lead in the selection and oversight of CROs and other vendors
  • Develop and lead the review of clinical outsourcing strategies and plans
  • Manage assigned clinical trial budgets
  • Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
  • Initiate and lead monitoring oversight activities in accordance with ICH/GCP standards
  • Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct
  • Maintain oversight and participate in the review of departmental SOPs to ensure compliance
  • Develop and maintain strong, collaborative relationships with key stakeholders

Qualifications:

  • B.S/B.A. degree in a science-related field
  • 7+ years of clinical research experience, including clinical trial execution and reporting

Skills, Knowledge & Abilities:

  • Proven capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management and data cleaning
  • Excellent verbal and written communication skills
  • Experience in a start-up environment preferred
  • Strong medical/scientific writing skills
  • Proven track record of effective leadership
  • Must be pro-active team player, flexible, and open to change
  • Knowledge of GCP and ICH
  • Previous experience with FDA/MHRA/PMDA inspections desired
  • Experience in multiple phases of research preferred
  • Experience authoring protocols and clinical sections of clinical documents

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.