Strategic Director, Global Clinical Development

PTC Therapeutics, Inc.; New York (NY); On-site; USD 267,000 - 336,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision plans

Retirement savings plan

Job summary

PTC Therapeutics, Inc. is seeking a Director of Clinical Development to provide tactical oversight across all phases of clinical drug development.

You will design and execute Clinical Development Plans (CDPs), lead protocol development, and liaise with external stakeholders to advance programs. The role requires an MD with 2+ years of clinical development experience, global program management, and strong regulatory knowledge.

Qualifications

• MD degree and a minimum of 2 years of clinical drug development experience.
• Experience managing one or more global clinical programs.
• Knowledge of regulatory submissions and drug development milestones.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Willingness to travel domestically and internationally (up to 25%).
• Board certification or equivalent in medical/clinical specialty (preferred).
• Experience working in rare/orphan disease clinical development (preferred).

Responsibilities

• Contributes to, reviews and approves study protocols, amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials.
• Approves investigator sites for inclusion in study/studies. Plans and facilitates investigator meetings and presents selected sections of the agenda/content.
• Prepares weekly and/or monthly study update reports which contain detailed information on enrollment data and adverse events as well as other general information relating to the progress of the study.
• Interprets, summarizes and documents clinical data for CSRs, regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.) manuscripts, promotional material and other publications as required.
• Registers and monitors clinical study timelines.
• Contributes to vendor selection process and manages PTC’s relationship with certain external vendors, partners and investigators.
• May represent the clinical study team at cross-functional, integrated team meetings.
• Ensures adherence to appropriate regulations and SOPs.
• Participates in the clinical review and recommendation of new opportunities such as target selections or clinical due diligence.
• Provides clinical/medical input to non-clinical and commercial functions.
• Performs other tasks and assignments as needed and specified by management.

Skills

MD degree

Clinical drug development

Global program management

Regulatory submissions

Microsoft Office

Verbal and written communication

Team collaboration

Travel ability

Orphan/rare disease experience

Education

MD degree

Board certification or equivalent

Job description

PTC Therapeutics, Inc. is seeking a Director of Clinical Development to provide tactical oversight across all phases of clinical drug development.

You will design and execute Clinical Development Plans (CDPs), lead protocol development, and liaise with external stakeholders to advance programs. The role requires an MD with 2+ years of clinical development experience, global program management, and strong regulatory knowledge.