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 Project Leader of the Innovation Team (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:
- Contributes to PTC’s global clinical development strategy for his/her assigned indication and/or Therapeutic Area and leads the implementation of the clinical strategy.
- 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 vendors, consultants, collaborators, etc.); monitors program/study budgets to ensure the timely and cost-effective implementation of CDP(s); reviews and approves contracts, work orders and invoices within grant of authority; participates in the assessment of CROs, vendors, consultants or other partners as necessary.
- Medically responsible for clinical studies.
- Facilitates communication and collaboration with internal, cross-functional team members including, but not limited to, research, manufacturing, drug supply, regulatory, quality assurance, marketing and external key stakeholders including, but not limited to, collaborators, KOLs, investigators and domestic and international regulatory authorities, to support CDPs, regulatory submissions and clinical development goals.
- Ensures adherence to the highest scientific, ethical and regulatory standards and ensures compliance with all applicable GCP regulatory requirements
- Represents PTC's Clinical Development team in meetings with external collaborators regarding the status of partnered clinical development projects
- Supports the assessment of in-licensing product candidates in area of expertise, as needed.
- May manage, coach and mentor direct reports.
- Performs other tasks and assignments as needed and specified by management.
- Advanced degree, may include MD, Ph.D. or PharmD., and a minimum of 5 years of progressively responsible and related experience in a pharmaceutical, biotechnology or related environment.