Director, Clinical Development
$286.9k - $336kPTC Therapeutics Inc
PTC Therapeutics seeks a Director of Clinical Development to oversee clinical and medical aspects of drug development across all trial phases. The role involves designing and executing clinical development plans, managing regulatory compliance, and serving as clinical liaison with external stakeholders in a global biopharmaceutical setting.
Responsibilities
- Review and approve study protocols, amendments, investigator brochures, case report forms, and clinical study reports
- Approve investigator sites, plan investigator meetings, and present key study information
- Prepare weekly and monthly study updates with enrollment and adverse event data
- Interpret and document clinical data for regulatory submissions, CSRs, and publications
- Approve clinical timelines, manage vendor relationships, and participate in cross-functional team meetings
Requirements
- MD degree with minimum 2 years clinical drug development experience in pharma or biotech
- Demonstrated experience managing one or more global clinical programs
- Expertise in clinical trial design, data interpretation, and regulatory submissions
- Knowledge of pharmaceutical industry, drug development processes, and regulatory frameworks
- Ability to influence without direct authority and work independently and collaboratively
- Excellent verbal and written communication skills and Microsoft Office proficiency
- Analytical thinking with strong problem-solving and project prioritization abilities
Compensation: $286,900 - $336,000 base salary
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