Global Senior Director, Orphan Disease Clinical Development

PTC Therapeutics, Inc.; North Carolina; On-site; USD 289,000 - 364,000; Full time

Job summary

PTC Therapeutics, Inc. in the United States is seeking a Senior Director, Clinical Development to shape the clinical strategy across multiple programs in a high-impact, rare-disease portfolio.

You will lead cross-functional teams, partner with CROs and KOLs, and ensure compliance with GCP standards while driving regulatory submissions and external collaborations. This executive role requires an MD with 5+ years in clinical drug development, global program oversight, and the ability to travel

Qualifications

• MD degree and 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.
• Demonstrated working knowledge of early- and late-phase drug development and applicable regulatory processes.
• Demonstrated ability to lead/oversee clinical trial design, conduct and interpretation of clinical data.
• Hands-on experience with the development of regulatory submissions.
• Ability to travel domestically and internationally.
• Board certification or equivalent in a medical or clinical specialty
• Experience working in rare/orphan disease clinical development.
• Previous supervisory experience.

Responsibilities

• Leads, contributes to and directs PTC’s global clinical development strategy for his/her assigned indication and/or therapeutic area.
• Leads/Facilitates the design of CDPs and ensures they enable PTC to: 1) demonstrate clinical/medical benefit(s) and 2) achieve compound and commercial development objectives; provides clinical input to non-clinical and commercial functions on matters related to these objectives.
• Manages relationships with external partners (e.g. Clinical Research Organizations (CROs) and other vendors, consultants, collaborators, etc.); monitors program/study budgets to ensure the timely and cost-effective implementation of CDP(s); reviews and approves contracts, work orders and invoices within grant of authority; participates in the assessment of CROs, vendors, consultants or other partners as necessary.
• Medically responsible for clinical studies.
• Facilitates communication and collaboration with internal, cross-functional team members including, but not limited to, research, manufacturing, drug supply, regulatory, quality assurance, marketing and external key stakeholders including, but not limited to, collaborators, KOLs, investigators and domestic and international regulatory authorities, to support CDPs, regulatory submissions and clinical development goals.
• Ensures adherence to the highest scientific, ethical and regulatory standards and ensures compliance with all applicable GCP regulatory requirements
• Represents PTC's Clinical Development team in meetings with external collaborators regarding the status of partnered clinical development projects
• Supports the assessment of in-licensing product candidates in area of expertise, as needed.
• May manage, coach and mentor direct reports.
• Performs other tasks and assignments as needed and specified by management.

Skills

Clinical development leadership

Regulatory knowledge

Trial design & data interpretation

Cross-functional collaboration

Communication

Travel readiness

Education

MD degree

Board certification or equivalent

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc. in the United States is seeking a Senior Director, Clinical Development to shape the clinical strategy across multiple programs in a high-impact, rare-disease portfolio.

You will lead cross-functional teams, partner with CROs and KOLs, and ensure compliance with GCP standards while driving regulatory submissions and external collaborations. This executive role requires an MD with 5+ years in clinical drug development, global program oversight, and the ability to travel