Senior Vice President, Clinical Development; MD

Overview

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.

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The Senior Vice President, Clinical Development is responsible for providing strategic leadership for the clinical/medical aspects of all phases of drug development across all therapeutic areas, compounds and/or indications. The incumbent is accountable for ensuring that clinical trials and protocols are properly designed and executed in accordance with applicable Good Clinical Practice (GCP) regulations. He/she is also accountable for defining and leading the strategic design of programs/studies such that there is strategic alignment across the portfolio.

The role provides oversight for the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical and regulatory objectives, and the documentation of study results. This includes, but may not be limited to, overseeing the activities of the Clinical organization.

The incumbent is a key representative of PTC’s clinical development organization in meetings with external stakeholders and audiences as needed; he/she may also author, or review for scientific/medical purposes, clinical/medical-related materials intended for internal and/or external audiences.

He/she manages direct and indirect reports. The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues. The Senior Vice President, Clinical Development is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Provides strategic and technical guidance and leads the global clinical development strategy for all therapeutic areas, compounds, and/or indications from pre-IND registration through late stage clinical development (which may include post-registration required studies) and ensures the design of Clinical Development Plans (CDPs) to enable PTC to:
  1) demonstrate clinical/medical benefit(s) and
  2) achieve compound and business objectives; provides clinical/medical input to non-clinical and commercial functions on matters related to these objectives.

• Directs relationships with external partners (e.g. 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.

• In partnership with the Development Leadership Team, contributes to ensuring all Development functions are, and remain, strategically aligned to the company’s goals and to Development’s objectives.

• Provides input into Clinical Development oversight through the Development Leadership Review meetings

• Partners with other core functions (e.g. Clinical Operations, Regulatory Affairs, Pharmacovigilance and Biostatistics/Data Management, etc.) to ensure that clinical development activities are defined and executed in a manner that is compliant and achieves clinical and regulatory milestones.

• Facilitates communication and collaboration with internal, cross-functional team members (e.g. research, manufacturing, drug supply, regulatory, quality, project management, marketing, domestic and international regulatory authorities, etc.) to support CDPs, regulatory submissions and corporate goals.

• Ensures adherence to the highest scientific, ethical, and regulatory standards and ensures compliance with all applicable GCP regulatory requirements.

• May represent PTC’s Clinical development team in meetings with external collaborators regarding the status of partnered clinical development projects.

• May support the…