Senior Director, Global Clinical Development

PTC Therapeutics, Inc.; Massachusetts; On-site; USD 267,000 - 336,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision benefits

Retirement plan

Job summary

PTC Therapeutics, Inc. is seeking a Director, Clinical Development to provide tactical oversight across all phases of clinical drug development.

The role leads design and execution of CDPs, trials and protocols while aligning with GCP and regulatory expectations. The director will collaborate cross-functionally with internal teams and external partners, review study results, manage timelines, vendor relationships, and support regulatory submissions.

Qualifications

• MD degree and at least 2 years of clinical drug development experience.
• Demonstrated leadership of one or more global clinical programs.
• Knowledge of regulatory submissions and GCP.
• Excellent verbal and written communication skills.
• Ability to influence without direct authority.
• Willingness to travel up to 25%.

Responsibilities

• Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures, CSRs, ICFs and CRFs.
• Approves investigator sites for inclusion in study/studies and facilitates investigator meetings.
• Prepares weekly/monthly study update reports with enrollment and adverse events data.
• Interprets, summarizes and documents clinical data for CSRs and regulatory documents.
• Approves and monitors clinical study timelines.
• Contributes to vendor selection and manages relationships with external vendors, partners and investigators.
• May represent the clinical study team at cross-functional meetings and ensures SOP/regulatory compliance.
• Provides clinical input to non-clinical and commercial functions.

Skills

MD degree

Regulatory submissions

Clinical trial design

Cross-functional collaboration

Oral and written communication

Travel readiness

Education

MD degree or equivalent

Board certification or equivalent in a medical/clinical specialty

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc. is seeking a Director, Clinical Development to provide tactical oversight across all phases of clinical drug development.

The role leads design and execution of CDPs, trials and protocols while aligning with GCP and regulatory expectations. The director will collaborate cross-functionally with internal teams and external partners, review study results, manage timelines, vendor relationships, and support regulatory submissions.