Director, Clinical Development
PTC Therapeutics, Inc.
September 04, 2026
Remote friendly (New Jersey, United States)
United States
Clinical Research and Development
Job Description Summary
Director, Clinical Development provides tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.
Responsibilities (Primary Duties)
- Contribute to, review, and approve study protocols, amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), informed consent forms (ICFs), case report forms (CRFs), and other clinical trial documents.
- Approve investigator sites; plan and facilitate investigator meetings.
- Prepare weekly/monthly study update reports (enrollment, adverse events, and study progress).
- Interpret, summarize, and document clinical data for CSRs, regulatory documents (e.g., INDs, annual reports, NDAs, MAAs), manuscripts, promotional materials, and publications.
- Approve and monitor clinical study timelines.
- Contribute to vendor selection; manage relationships with external vendors/partners/investigators.
- Represent the clinical study team at cross-functional/integrated meetings as needed.
- Ensure adherence to applicable regulations and SOPs.
- Participate in clinical review/recommendation of new opportunities (e.g., target selection, clinical due diligence).
- Provide clinical/medical input to non-clinical and commercial functions.
Qualifications (Required)
- MD degree and at least 2 years of clinical drug development experience.
- Demonstrated experience managing one or more global clinical programs.
- Expertise in clinical trial design, conduct, and interpretation; knowledge of global drug development and regulatory processes.
- Previous experience with regulatory submissions.
Preferred
- Board certification/equivalent in a medical/clinical specialty.
- Experience in rare/orphan disease clinical development.
Skills/Abilities
- Influence without direct authority; strong communication (verbal/written).
- Microsoft Office proficiency; analytical/problem-solving; planning/organization/time management.
- Ability to work in a fast-paced, matrixed environment; travel (domestic/international) up to 25%.
Compensation/Benefits (as stated)
- Eligible for short- and long-term incentives; medical, dental, vision, and retirement savings plans.
Director, Clinical Development provides tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.
Responsibilities (Primary Duties)
- Contribute to, review, and approve study protocols, amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), informed consent forms (ICFs), case report forms (CRFs), and other clinical trial documents.
- Approve investigator sites; plan and facilitate investigator meetings.
- Prepare weekly/monthly study update reports (enrollment, adverse events, and study progress).
- Interpret, summarize, and document clinical data for CSRs, regulatory documents (e.g., INDs, annual reports, NDAs, MAAs), manuscripts, promotional materials, and publications.
- Approve and monitor clinical study timelines.
- Contribute to vendor selection; manage relationships with external vendors/partners/investigators.
- Represent the clinical study team at cross-functional/integrated meetings as needed.
- Ensure adherence to applicable regulations and SOPs.
- Participate in clinical review/recommendation of new opportunities (e.g., target selection, clinical due diligence).
- Provide clinical/medical input to non-clinical and commercial functions.
Qualifications (Required)
- MD degree and at least 2 years of clinical drug development experience.
- Demonstrated experience managing one or more global clinical programs.
- Expertise in clinical trial design, conduct, and interpretation; knowledge of global drug development and regulatory processes.
- Previous experience with regulatory submissions.
Preferred
- Board certification/equivalent in a medical/clinical specialty.
- Experience in rare/orphan disease clinical development.
Skills/Abilities
- Influence without direct authority; strong communication (verbal/written).
- Microsoft Office proficiency; analytical/problem-solving; planning/organization/time management.
- Ability to work in a fast-paced, matrixed environment; travel (domestic/international) up to 25%.
Compensation/Benefits (as stated)
- Eligible for short- and long-term incentives; medical, dental, vision, and retirement savings plans.