Senior Director, Global Clinical Development Strategy

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

Benefits offered by this job

Medical, dental, vision insurance

Retirement savings plans

Job summary

PTC Therapeutics is seeking a Senior Director, Clinical Development to provide strategic input across all phases of the drug development process and to lead cross-functional teams including clinical operations, drug safety, and biostatistics.

The role oversees CDPs, ensures adherence to GCP, and maintains external relationships with KOLs and academic consortia while aligning with regulatory requirements and SOPs.

Qualifications

• 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 influence without direct authority.
• Excellent verbal and written communication skills.
• Ability to travel domestically and internationally.

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 demonstrate clinical/medical benefit and achieve development objectives.
• Manages relationships with external partners; monitors budgets and approves contracts and invoices.
• Medically responsible for clinical studies and oversees cross-functional collaboration to support CDPs, regulatory submissions and goals.
• Represents the Clinical Development team in meetings with external collaborators and stakeholders.

Education

MD degree

Tools

Microsoft Office

Job description

PTC Therapeutics is seeking a Senior Director, Clinical Development to provide strategic input across all phases of the drug development process and to lead cross-functional teams including clinical operations, drug safety, and biostatistics.

The role oversees CDPs, ensures adherence to GCP, and maintains external relationships with KOLs and academic consortia while aligning with regulatory requirements and SOPs.