Senior Director, Clinical Development

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 Senior Director, Clinical Development provides strategic input for the clinical/medical aspects of all phases of the drug development process and will work closely with the leader of research and development team to achieve the clinical development goals for these compounds. The incumbent is accountable for ensuring that Clinical Development Plans (CDPs), clinical trials and protocols are properly designed and that they are executed in accordance with applicable Good Clinical Practice (GCP) regulations. The incumbent has medical responsibilities for assigned clinical studies and leads the analyses 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.  He/she oversees the activities of multiple functions aligned with clinical development projects within the Clinical Development organization, including but not limited to: clinical operations, drug safety, and biostatistics. He/she also has the primary responsibility for establishing and maintaining external relationships and alliances with Key Opinion Leaders (KOLs) and academic consortia. The Senior Director, Clinical Development is a key representative of PTC's clinical development organization in meetings with external stakeholders and audiences as needed; as such he/she may author or review, for quality purposes, 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 Senior Director, Clinical Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.  . Job Description: ESSENTIAL FUNCTIONS Primary duties/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: 1) demonstrate clinical/medical benefit(s) and 2) achieve compound and commercial development objectives; provides clinical input to non-clinical and commercial functions on matters related to these objectives. Manages relationships with external partners (e.g. Clinical Research Organizations (CROs) and other…