Job Description: Contract, Associate Director, Clinical Operations

Employment Type: Full time

Company Information

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years, our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture: www.ptcbio.com

Position Overview

The Contract, Associate Director, Clinical Operations provides the scientific and operational expertise required to lead the execution of the complete life cycle of clinical trials in accordance with appropriate regulatory requirements for one or more indications within or across therapeutic areas. The incumbent works as an integrated member of the clinical team to manage clinical trial(s) from study design through close out. The Contract, Associate Director, Clinical Operations may manage direct report(s). The incumbent works cross-functionally with internal departments and external resources on Clinical Operations related issues. The Contract, Associate Director, Clinical Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities

Primary Duties/Responsibilities:

• Clinical Trial Execution:
  • Act as an integrated member of the clinical team to lead, direct, and contribute to the planning, execution, and reporting of clinical trials.
  • Manage clinical trial(s) from study design through close out.
  • Estimate clinical project timelines.
  • Contribute to protocol writing and Case Report Form (CRF) design.
  • Participate in site selection and study drug forecasting.
  • Manage sites and Clinical Research Organizations (CROs).
  • Review data and contribute to study reporting.
  • Recommend monitoring, safety, eligibility, enrollment, and data consistency strategies.
• Collaboration and Strategy:
  • Interact with external and internal project team members to assist in the development of clinical strategies, trial design, study plans, and project deliverables.
  • Meet with investigators and PTC scientific and clinical staff to obtain direction and feedback.
• Protocol Development:
  • Assist in the evaluation of scientific literature and investigator advice regarding current clinical practice as a component of clinical strategy and protocol development.
  • Write, review, and/or edit study protocols, protocol amendments, study manuals, informed consent forms, and related documents.
• Site and Vendor Management:
  • Prepare investigational site lists and participate in the review and approval of investigational sites.
  • Negotiate contracts and budgets with sites and vendors and present to the project team for approval.
  • Plan, coordinate, and conduct investigator meetings, including presentations.
  • Respond to questions from sites and trial monitors regarding trial conduct.
• Project Management and Budget:
  • Manage clinical study timelines using appropriate project management tools.
  • Develop budgets and manage expenditures for the clinical trial program, including those for investigational sites and vendors.
  • Present project progress reports through accurate, succinct summaries of clinical study work at internal team meetings and investigator meetings.
• Regulatory Submissions and Reporting:
  • Facilitate regulatory submissions and communications by working with appropriate team members during the submission process.
  • Write assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences.
• Data Review and Interpretation:
  • Provide on-going review of clinical trial data to ensure timely, consistent, and accurate data.
  • Assist in the interpretation of clinical data in preparation for clinical study reports and regulatory submissions.
• Team Leadership:
  • Manage, coach, and mentor direct reports.

Requirements

• Education: Bachelor’s degree in a scientific discipline.
• Experience: Minimum of 7 years of progressively responsible US and/or global experience in clinical research.

Additional Information

• Salary: [Information not provided]
• Location Type: [Information not provided]