Associate Director, Clinical Operations

Position Overview

• Location Type: [Not Specified]
• Job Type: Full time
• Salary: [Not Specified]

PTC Therapeutics is a global commercial biopharmaceutical company dedicated to extending life’s moments for children and adults living with rare diseases for over 25 years. We cultivate an inclusive culture where everyone feels valued, respected, and empowered, welcoming candidates from all backgrounds.

Job Summary

The Associate Director, Clinical Operations provides scientific and operational expertise to lead the execution of clinical trials throughout their lifecycle, adhering to regulatory requirements. This role involves managing clinical trials from study design to close-out as an integrated member of the clinical team. The Associate Director may also manage direct reports and collaborate cross-functionally with internal departments and external resources on Clinical Operations matters, ensuring adherence to regulatory requirements and company SOPs.

Essential Functions

• Clinical Trial Management: Lead, direct, and contribute to the planning, execution, and reporting of clinical trials. This includes estimating timelines, writing protocols, designing Case Report Forms (CRFs), selecting sites, forecasting study drug, managing sites and Clinical Research Organizations (CROs), reviewing data, and reporting study outcomes. Recommends strategies for monitoring, safety, eligibility, enrollment, and data consistency.
• Cross-functional Collaboration: Interact with external and internal project team members to develop clinical strategies, trial designs, study plans, and project deliverables. Engage with investigators and PTC scientific and clinical staff for direction and feedback.
• Protocol Development: Assist in evaluating scientific literature and investigator advice for 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 their review and approval. Negotiate contracts and budgets with sites and vendors. Plan, coordinate, and conduct investigator meetings, including presentations. Respond to inquiries from sites and trial monitors regarding trial conduct.
• Project and Budget Management: Manage clinical study timelines using appropriate project management tools. Develop budgets and manage expenditures for clinical trial programs, including those for investigational sites and vendors. Present project progress reports with accurate summaries at internal team meetings and investigator meetings.
• Regulatory Submissions: Facilitate regulatory submissions and communications by collaborating with appropriate team members. Write assigned sections of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences.
• Data Review and Interpretation: Conduct ongoing reviews of clinical trial data to ensure timeliness, consistency, and accuracy. Assist in interpreting clinical data for clinical study reports and regulatory submissions.
• Team Leadership: Manage, coach, and mentor direct reports.

Knowledge, Skills, and Abilities Required

• Minimum of a Bachelor’s degree in a scientific discipline.
• A minimum of 7 years of progressively responsible US and/or global experience in clinical research within the pharmaceutical or biotechnology industry.

Company Information

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