Director, Clinical Development — Global Trials Lead

PTC Therapeutics, Inc.

New Jersey

On-site

USD 287,000 - 336,000

Full time

6 hours ago
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Job summary

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

You will design and execute Clinical Development Plans, lead trials, and ensure regulatory compliance with GCP while collaborating across internal and external teams. The role involves representing the clinical team in meetings with stakeholders, partners, and regulators, reviewing materials for external audiences and ensuring

Qualifications

  • MD degree and a minimum of 2 years of clinical drug development experience.
  • Experience managing one or more global, clinical programs.
  • Knowledge of regulatory processes and global drug development milestones.
  • Ability to influence without direct authority.
  • Excellent verbal and written communication skills.
  • Ability to travel domestically and internationally.

Responsibilities

  • Contributes to study protocol development, amendments and related clinical documents.
  • Oversees investigator sites and facilitates meetings and agenda content.
  • Prepares study update reports with enrollment and adverse event data.
  • Interprets and documents clinical data for reports and publications.
  • Manages study timelines and vendor relationships.

Skills

Clinical drug development
Regulatory submissions
Leadership
MS Office

Education

MD degree

Tools

MS Office

Job description

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

You will design and execute Clinical Development Plans, lead trials, and ensure regulatory compliance with GCP while collaborating across internal and external teams. The role involves representing the clinical team in meetings with stakeholders, partners, and regulators, reviewing materials for external audiences and ensuring

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