Senior Director, Clinical Development Strategy

PTC Therapeutics, Inc; North Carolina; Hybrid; USD 289,000 - 364,000; Full time

Job summary

PTC Therapeutics, Inc is seeking a Senior Director, Clinical Development to provide strategic input across all phases of drug development and to partner with the R&D leader to achieve clinical development goals.

The incumbent ensures CDPs, trials and protocols are designed and executed per GCP, leads medical oversight of studies, and coordinates with clinical operations, biostatistics and safety, CROs, KOLs and regulators to advance programs.

Qualifications

• MD degree and at least 5 years of clinical drug development experience.
• Experience leading a large, multi-country clinical development program.
• Knowledge of early- and late-phase drug development and regulatory processes.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.

Responsibilities

• Lead global clinical development strategy for assigned indication/therapeutic area.
• Design CDPs and ensure they enable clinical and commercial objectives; provide input to other functions.
• Manage relationships with CROs/vendors and monitor budgets.
• Medically responsible for clinical studies.
• Coordinate with cross-functional teams and external stakeholders (KOLs, regulators).
• Ensure adherence to GCP and regulatory standards.
• Represent the Clinical Development team in external meetings.
• Mentor direct reports; perform other management tasks as needed.

Skills

MD degree

5+ years experience

Clinical drug development

Leadership

Regulatory processes

Clinical trial design

Regulatory submissions

Microsoft Office

Communication skills

Time management

Travel ability

Education

MD degree

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 and to partner with the R&D leader to achieve clinical development goals.

The incumbent ensures CDPs, trials and protocols are designed and executed per GCP, leads medical oversight of studies, and coordinates with clinical operations, biostatistics and safety, CROs, KOLs and regulators to advance programs.