Director, Clinical Development

PTC Therapeutics, Inc.; Warren Township (IA); On-site; USD 180,000 - 240,000; Full time

Job summary

PTC Therapeutics, Inc. seeks a Director of Clinical Development to provide tactical oversight for all phases of clinical drug development.

You will help design, develop and execute Clinical Development Plans, oversee trials and protocols in alignment with GCP and SOPs, and lead analysis and communication with external stakeholders as needed. The role requires cross-functional collaboration with internal teams and external partners, ensuring adherence to regulatory requirements and strategic

Responsibilities

• 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

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team , fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

The Director, Clinical Development provides tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.

The incumbent is involved in the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable Good Clinical Practice (GCP) regulations. The incumbent leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical, regulatory and commercial objectives and the documentation of study results.

As needed, he/she may be assigned as the primary clinical/medical representative in meetings with external stakeholders, partners or other external audiences as needed. This includes, but may not be limited to, Key Opinion Leaders (KOLs), investigators, regulatory authorities, partners, vendors, consultants, etc. As such he/she may author or review clinical/medical-related materials intended for external audiences.

The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues.

The Director, Clinical Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• 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