Global Director, Clinical Development & Strategy

PTC Therapeutics, Inc.; Maryland; On-site; 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. is seeking a Director, Clinical Development to provide tactical oversight of the clinical/medical aspects of all phases of drug development. The role designs Clinical Development Plans (CDPs), protocols and trials in line with GCP and leads cross-functional teams with internal departments and external partners.

You will review study results, interact with regulatory authorities and KOLs, ensure SOPs, and mentor teams. Travel up to 25% domestically and internationally.

Qualifications

• MD degree and a minimum of 2 years of clinical drug development experience within a pharmaceutical, biotechnology or related environment.
• Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
• Knowledge of regulatory submissions and global drug development processes.

Responsibilities

• Contributes to, reviews and approves study protocols and related clinical documents for trials.
• Prepares study update reports with enrollment data and adverse events information.
• Interprets and documents clinical data for CSRs, regulatory documents and publications.
• Ensures adherence to regulations, SOPs and vendor management activities.

Job description

PTC Therapeutics, Inc. is seeking a Director, Clinical Development to provide tactical oversight of the clinical/medical aspects of all phases of drug development. The role designs Clinical Development Plans (CDPs), protocols and trials in line with GCP and leads cross-functional teams with internal departments and external partners.

You will review study results, interact with regulatory authorities and KOLs, ensure SOPs, and mentor teams. Travel up to 25% domestically and internationally.