Global Clinical Development Strategy Director

ptcbio; New Jersey; On-site; USD 150,000 - 210,000; Full time

Job summary

PTC Therapeutics is a global biopharmaceutical company seeking a Senior Director, Clinical Development in New Jersey to lead global clinical development strategy for assigned indications. This role partners with the leader of the R&D team to ensure CDPs, trials, and protocols adhere to Good Clinical Practice and regulatory standards while aligning with commercial goals.

The incumbent oversees clinical operations, drug safety, and biostatistics, and collaborates with KOLs, investigators, and

Qualifications

• MD degree and a minimum of 5 years of clinical drug development experience in a pharmaceutical/biotech environment.
• Demonstrated hands-on experience leading multi-country clinical development programs.
• Experience with regulatory submissions and external collaborations.

Responsibilities

• Lead global clinical development strategy for assigned indications and therapeutic areas.
• Design CDPs and CDP-related trials to meet clinical, regulatory and commercial objectives.
• Manage external partners (CROs, vendors) and monitor budgets for CDP execution.
• Medically responsible for clinical studies and review study results and regulatory submissions.
• Collaborate cross-functionally with research, manufacturing, regulatory, quality assurance, and external stakeholders.

Skills

Leadership

Clinical trial design

Regulatory submissions

Stakeholder management

Education

MD degree

Job description

PTC Therapeutics is a global biopharmaceutical company seeking a Senior Director, Clinical Development in New Jersey to lead global clinical development strategy for assigned indications. This role partners with the leader of the R&D team to ensure CDPs, trials, and protocols adhere to Good Clinical Practice and regulatory standards while aligning with commercial goals.

The incumbent oversees clinical operations, drug safety, and biostatistics, and collaborates with KOLs, investigators, and