Senior Director, Global Clinical Development Strategy

PTC Therapeutics, Inc

Massachusetts

Hybrid

USD 289,000 - 364,000

Full time

7 days ago
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Job summary

PTC Therapeutics, Inc is seeking a Senior Director, Clinical Development to lead the global clinical development strategy across indications and work closely with the R&D leader to achieve CDP goals. The role ensures trials are designed and conducted per GCP and oversees external partnerships.

The incumbent leads cross-functional teams, maintains regulatory relationships, and drives alignment with clinical, regulatory, and commercial objectives. Travel up to 30% may be required.

Qualifications

  • MD degree and a minimum of 5 years of clinical drug development experience.
  • Demonstrated hands-on experience leading a large, multi-country, clinical development program.
  • Knowledge of early- and late-phase drug development and applicable regulatory processes.
  • Ability to influence without direct authority.
  • Experience with regulatory submissions.
  • Excellent communication and collaborative skills in a matrix environment.

Responsibilities

  • Lead global clinical development strategy for assigned indication/therapeutic area.
  • Design and ensure CDPs enable clinical and commercial objectives; advise non-clinical and commercial teams.
  • Manage relationships with CROs, vendors, consultants, and collaborators; monitor budgets; review contracts and invoices.
  • Medically responsible for clinical studies and interpret results to assess regulatory and commercial objectives.
  • Facilitate cross-functional collaboration with R&D, manufacturing, regulatory, QA, marketing, and external stakeholders.
  • Ensure adherence to GCP and regulatory standards; represent the team in external meetings.
  • Mentor/coach direct reports; perform tasks as needed by management.

Skills

Leadership
Cross-functional collaboration
Regulatory knowledge
Communication
Analytical thinking
Travel flexibility
Microsoft Office
Independent work

Education

MD degree
5+ years clinical drug development experience

Tools

Regulatory submissions
Microsoft Office

Job description

PTC Therapeutics, Inc is seeking a Senior Director, Clinical Development to lead the global clinical development strategy across indications and work closely with the R&D leader to achieve CDP goals. The role ensures trials are designed and conducted per GCP and oversees external partnerships.

The incumbent leads cross-functional teams, maintains regulatory relationships, and drives alignment with clinical, regulatory, and commercial objectives. Travel up to 30% may be required.

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