Director, Global Clinical Development & Trials

PTC Therapeutics, Inc.; Connecticut; In loco; USD 267.000 - 336.000; Tempo pieno

Vantaggi offerti da questo lavoro

Short- and long-term incentives

Medical, dental, vision, retirement

Descrizione del lavoro

PTC Therapeutics, Inc. is seeking a Director of Clinical Development to oversee clinical/medical aspects across all phases of drug development. The role involves designing CDPs, leading trials and writing regulatory materials, while ensuring GCP compliance and collaboration with external stakeholders.

The position requires an MD and experience with global programs. The incumbent will manage study timelines, vendor relationships, and internal cross-functional teamwork, traveling domestically and

Competenze

• MD degree and a minimum of 2 years of clinical drug development experience.
• Demonstrated ability to influence without direct authority and to work in a fast-paced, matrixed environment.
• Experience managing global clinical programs and regulatory submissions.

Mansioni

• Contributes to study protocols, amendments and CSRs and other essential clinical documents.
• Prepares study update reports with enrollment and adverse event data.
• Partners with vendors, external sites and investigators; may represent the study team in cross-functional meetings.
• Ensures adherence to regulations and company SOPs; supports due diligence for new opportunities.

Conoscenze

Verbal communication

Written communication

Analytical thinking

Cross-functional collaboration

Formazione

MD degree

Board certification

Strumenti

Microsoft Office

Descrizione del lavoro

PTC Therapeutics, Inc. is seeking a Director of Clinical Development to oversee clinical/medical aspects across all phases of drug development. The role involves designing CDPs, leading trials and writing regulatory materials, while ensuring GCP compliance and collaboration with external stakeholders.

The position requires an MD and experience with global programs. The incumbent will manage study timelines, vendor relationships, and internal cross-functional teamwork, traveling domestically and