PTC Therapeutics, Inc.
Senior Director, Early Clinical Development (Project Management)
The incumbent, in collaboration with the Research groups, contributes to and implements biomarker strategy for clinical studies focusing in particular on pharmacokinetics, pharmacodynamics, proof of mechanism and patient selection (companion diagnostics). The incumbent, in collaboration with others in Clinical Development, ensures the design and execution of appropriate Clinical Development Plans (CDPs) to generate FIH, PK, PD, PK/PD, or efficacy/PoC and natural history data that enables PTC to: 1) to support continued clinical development or no-go for program and 2) achieve compound and commercial development objectives. The incumbent may provide clinical/medical input to non-clinical and commercial functions on matters related to these objectives. The incumbent contributes to Investigator Brochures, Clinical Study Protocols and Reports, program documents and regulatory submissions and responses (INDs/CTAs). She/he may also co-author, assist and/or support the development of publications, abstracts, and presentations.
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 she/he 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 Early Clinical Development related issues.
The Senior Director, Early Clinical Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
* Minimum level of education and years of relevant work experience.
* Special knowledge or skills needed and/or licenses or certificates required.
*Special knowledge or skills and/or licenses or certificates preferred.
* Travel requirements: 20 – 30 %
**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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