Global Director, Clinical Development

PTC Therapeutics, Inc; North Carolina; Hybride; USD 267 000 - 336 000; Plein temps

Résumé du poste

PTC Therapeutics, Inc. in North Carolina seeks a Director of Clinical Development to oversee the clinical/medical aspects across all phases of drug development.

You will design and execute CDPs, lead trials, analyze results and prepare external materials for stakeholders. You will coordinate cross-functional teams, ensure GCP compliance, and manage timelines, vendors and partnerships while contributing to clinical due diligence and strategic opportunities.

Qualifications

• MD degree and a minimum of 2 years of clinical drug development experience within a pharmaceutical, biotechnology or related environment.
• Experience managing one or more global, clinical programs.
• Knowledge of the pharmaceutical/biotechnology industry, including global drug development and regulatory processes, with particular knowledge of R&D, key clinical milestones, and the factors influencing critical development and decision-making points.
• Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
• Previous experience with regulatory submissions.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to travel domestically and internationally.

Responsabilités

• Contributes to, reviews and approves study protocols, protocol 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.
• Approves 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.

Connaissances

Clinical development

Regulatory submissions

Trial design

Vendor management

Cross-functional collaboration

Travel

Communication

Microsoft Office

Formation

MD degree

Board certification or equivalent

Outils

Microsoft Office

Description du poste

PTC Therapeutics, Inc. in North Carolina seeks a Director of Clinical Development to oversee the clinical/medical aspects across all phases of drug development.

You will design and execute CDPs, lead trials, analyze results and prepare external materials for stakeholders. You will coordinate cross-functional teams, ensure GCP compliance, and manage timelines, vendors and partnerships while contributing to clinical due diligence and strategic opportunities.