Director, Clinical Development — Hybrid Leader

PTC Therapeutics, Inc; Maryland; Hybrid; USD 267,000 - 336,000; Full time

Job summary

PTC Therapeutics, Inc is seeking a Director of Clinical Development to oversee the clinical/medical aspects across all phases of drug development. The role involves designing CDPs, managing trials and protocols in line with GCP, and presenting results to stakeholders.

The incumbent may serve as the primary clinical/medical representative in meetings with external partners, KOLs, investigators, and regulatory authorities, while ensuring SOP compliance and cross-functional collaboration.

Qualifications

• MD degree and at least 2 years of clinical drug development experience.
• Experience managing one or more global clinical programs.
• Knowledge of pharmaceutical/biotech industry and regulatory processes (R&D milestones).
• Experience with regulatory submissions.
• Proficiency with Microsoft Office.
• Ability to travel domestically and internationally.

Responsibilities

• Contributes to, reviews and approves study protocols, amendments, manuals, IBs, CSRs, ICFs, CRFs and other documents for clinical trials.
• Approves investigator sites and facilitates investigator meetings.
• Prepares study update reports with enrollment data and adverse events.
• Interprets and documents clinical data for CSRs, regulatory documents, manuscripts, and publications.
• Approves and monitors clinical study timelines.
• Contributes to vendor selection and manages external relationships.
• Represents the clinical study team in cross-functional meetings.
• Ensures adherence to regulations and SOPs.
• Participates in clinical reviews and due diligence for new opportunities.
• Provides clinical input to non-clinical and commercial functions.

Skills

Clinical trial design

Regulatory submissions

Global program management

Communication skills

Analytical thinking

Travel ability

Education

MD degree

Board certification (preferred)

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc is seeking a Director of Clinical Development to oversee the clinical/medical aspects across all phases of drug development. The role involves designing CDPs, managing trials and protocols in line with GCP, and presenting results to stakeholders.

The incumbent may serve as the primary clinical/medical representative in meetings with external partners, KOLs, investigators, and regulatory authorities, while ensuring SOP compliance and cross-functional collaboration.