Global Director, Clinical Development & Trials

PTC Therapeutics, Inc; New York (NY); Hybrid; USD 267,000 - 336,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision coverage

Retirement savings plans

Job summary

PTC Therapeutics, Inc in the United States seeks a Director of Clinical Development to oversee clinical/medical activities across all phases of drug development, ensuring adherence to GCP and SOPs while coordinating with internal teams and external stakeholders.

The role includes design and execution of CDPs, protocol development, trial management, and preparation of CSRs and regulatory documents, with global program leadership and travel flexibility.

Qualifications

• MD degree with at least 2 years in clinical drug development
• Experience managing global clinical programs
• Knowledge of pharma/biotech regulatory processes and R&D milestones
• Expertise in clinical trial design, conduct and data interpretation
• Experience with regulatory submissions
• Ability to influence without direct authority
• Excellent verbal and written communication
• Ability to work independently and in cross-functional teams
• Analytical thinker with problem-solving skills
• Excellent planning, organization and time management
• Ability to travel domestically and internationally

Responsibilities

• Contributes to, reviews and approves study protocols, amendments, IBs, CSRs, ICFs, CRFs and other documents
• Prepares and presents study updates including enrollment and adverse events
• Interprets and documents clinical data for CSRs and regulatory documents
• Monitors study timelines and vendor relationships
• Represents the study team in cross-functional meetings
• Ensures adherence to regulations and SOPs
• Participates in clinical due diligence and opportunity review
• Provides clinical input to non-clinical and commercial functions
• Performs other tasks as needed

Skills

Communication skills

Analytical thinking

Problem solving

Time management

Independent & collaborative work

Education

MD degree

Board certification or equivalent

Experience in rare/orphan disease development

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc in the United States seeks a Director of Clinical Development to oversee clinical/medical activities across all phases of drug development, ensuring adherence to GCP and SOPs while coordinating with internal teams and external stakeholders.

The role includes design and execution of CDPs, protocol development, trial management, and preparation of CSRs and regulatory documents, with global program leadership and travel flexibility.