Director, Clinical Development & Strategy

PTC Therapeutics, Inc; Philadelphia (Philadelphia County); Sur place; USD 267 000 - 336 000; Plein temps

Résumé du poste

PTC Therapeutics, Inc. is seeking aDirector, Clinical Development to oversee clinical/medical aspects across all phases of drug development. The role leads CDPs, trials, and protocols, and collaborates with external stakeholders to advance regulatory and commercial objectives.

The incumbent ensures regulatory compliance, SOP adherence, and cross-functional execution, including external vendor management and opportunities such as due diligence.

Qualifications

• MD degree and at least 2 years of clinical drug development experience.
• Experience managing one or more global, clinical programs.
• Knowledge of global drug development, regulatory processes, and key milestones.
• Expertise in clinical trial design, conduct and data interpretation.
• Experience with regulatory submissions.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication; strong collaboration.
• Ability to travel domestically and internationally.

Responsabilités

• Contributes to and approves study protocols and related documents.
• Plans and facilitates investigator meetings.
• Prepares study update reports with enrollment and adverse events data.
• Interprets and documents clinical data for CSRs and regulatory documents.
• Approves and monitors study timelines.
• Manages vendor relationships and external partnerships.
• Represents the study team in cross-functional meetings.
• Ensures adherence to regulations and SOPs.
• Contributes to opportunities such as target selections or due diligence.
• Provides clinical input to non-clinical and commercial functions.

Connaissances

MD degree

Global programs

Regulatory knowledge

Clinical trial design

Regulatory submissions

Influence without authority

MS Office

Communication skills

Independent & collaborative work

Analytical thinking

Time management

Travel ability

Formation

MD degree

Outils

MS Office

Description du poste

PTC Therapeutics, Inc. is seeking aDirector, Clinical Development to oversee clinical/medical aspects across all phases of drug development. The role leads CDPs, trials, and protocols, and collaborates with external stakeholders to advance regulatory and commercial objectives.

The incumbent ensures regulatory compliance, SOP adherence, and cross-functional execution, including external vendor management and opportunities such as due diligence.