Global Senior Director, Clinical Development

PTC Therapeutics, Inc.; New Jersey; On-site; USD 289,000 - 364,000; Full time

Benefits offered by this job

Incentives

Job summary

PTC Therapeutics, Inc. is seeking a Senior Director, Clinical Development to provide strategic input across all phases of drug development.

This leader will collaborate with the head of R&D to shape Clinical Development Plans, oversee trials, and ensure alignment with GCP regulations. The role involves supervising cross-functional teams, managing CROs and external partners, advancing regulatory submissions, and representing the clinical development organization in external engagements with KOLs

Qualifications

• MD degree with a minimum of 5 years of clinical drug development experience in a pharmaceutical, biotechnology or related environment.
• Demonstrated hands-on experience leading a large, multi-country clinical development program.
• Experience developing regulatory submissions and ensuring regulatory compliance (GCP).

Responsibilities

• Leads global clinical development strategy for assigned indication/therapeutic area.
• Designs Clinical Development Plans (CDPs) to meet clinical, regulatory and commercial objectives.
• Manages relationships with CROs, vendors, consultants and collaborators; monitors budgets and approves contracts.
• Medically responsible for clinical studies and analyses.
• Represents the Clinical Development team in external stakeholder meetings and with KOLs and authorities.

Skills

Leadership

Clinical development

Regulatory knowledge

GCP

Communication

Travel flexibility

Education

MD degree

Board certification or equivalent

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc. is seeking a Senior Director, Clinical Development to provide strategic input across all phases of drug development.

This leader will collaborate with the head of R&D to shape Clinical Development Plans, oversee trials, and ensure alignment with GCP regulations. The role involves supervising cross-functional teams, managing CROs and external partners, advancing regulatory submissions, and representing the clinical development organization in external engagements with KOLs