Director, Clinical Development - Global Trials & Strategy

PTC Therapeutics, Inc

Connecticut

On-site

USD 267,000 - 336,000

Full time

7 days ago

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Job summary

PTC Therapeutics is seeking aDirector of Clinical Development to oversee the clinical/medical aspects of multi-phase drug development. You will design and execute Clinical Development Plans, lead trials and contribute to external communications with KOLs, regulatory authorities and partners.

The role requires MD degree, global program experience, and strong regulatory knowledge, with a focus on efficient, compliant trial execution in a fast-paced, matrixed environment.

Qualifications

MD degree and a minimum of 2 years of clinical drug development experience.
Experience managing one or more global clinical programs.
Knowledge of global drug development and regulatory processes, with emphasis on R&D milestones.
Experience with regulatory submissions.
Excellent verbal and written communication.

Responsibilities

Contributes to, reviews and approves study protocols, amendments, IBs, CSRs and other trial documents.
Approves investigator sites for inclusion and facilitates investigator meetings.
Prepares study update reports with enrollment and adverse event data.
Interprets, summarizes and documents clinical data for CSRs and regulatory manuscripts.
Monitors study timelines and manages vendor relationships.

Skills

Regulatory submissions

Clinical trial design

Microsoft Office

Verbal and written communication

Independent & collaborative work style

Travel flexibility

Education

MD degree

Job description

The role requires MD degree, global program experience, and strong regulatory knowledge, with a focus on efficient, compliant trial execution in a fast-paced, matrixed environment.

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