Senior Vice President, Clinical Development (MD)

Role Summary

The Senior Vice President, Clinical Development provides strategic leadership for the clinical/medical aspects of drug development across all therapeutic areas, compounds, and indications. They ensure trials and protocols are designed and executed in accordance with applicable Good Clinical Practice (GCP) regulations and design programs that align the portfolio. The role oversees the analysis of study results, assesses whether studies meet clinical and regulatory objectives, and documents outcomes, including oversight of the Clinical organization. The incumbent is a key representative of PTC’s clinical development organization in external meetings and may author or review clinical/medical materials; they manage direct and indirect reports and work cross-functionally to ensure regulatory compliance and SOP adherence.

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) 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 assessment of in-licensing product candidates in area of expertise, as needed.
• Interacts with Health Authorities including, but not limited to, Food and Drug Administration (FDA) and European Medicines Agency (EMA).
• Manages, coaches and mentors direct and indirect reports.
• Performs other tasks and assignments as needed and specified by management.

Qualifications

• Required: MD degree and a minimum of 12 years progressively responsible and strategic experience in clinical drug development (minimum of 6 years in a clinical leadership role) in a pharmaceutical, biotechnical, CRO or related environment and/or a minimum of 12 years of related professional experience in these same environments.
• Required: Strategic vision-setting abilities coupled with entrepreneurial, hands on approach.
• Required: Excellent, hands-on clinical trial design leadership and data interpretation experience.
• Required: Thorough working knowledge across a broad range of areas of drug development.
• Required: Hands-on New Drug Applications (NDAs)/Marketing Authorization Applications (MAA) submission experience.
• Required: Hands-on experience successfully developing, registering, and supporting compounds throughout their lifecycle.
• Required: Regulatory experience; significant interaction with health authorities within and outside of the U.S. (FDA, EMA, PMDA, etc.)
• Required: Hands-on experience managing multiple therapeutic areas and/or compounds.
• Required: Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
• Required: Ability to influence without direct authority.
• Required: Proficiency with Microsoft Office.
• Required: Excellent verbal and written communication and skills. Must have the ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena.
• Required: Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Required: Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Required: Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Preferred: Global experience.
• Preferred: Experience working in rare/orphan disease research.

Additional Requirements

• Travel: Up to 40%