Senior Vice President, Clinical Development (MD)

stering 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 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.

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.

Requirements
• 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.
• Strategic vision-setting abilities coupled with entrepreneurial, hands on approach.
• Excellent, hands-on clinical trial design leadership and data interpretation experience.
• Thorough working knowledge across a broad range of areas of drug development.
• Hands-on New Drug Applications (NDAs)/Marketing Authorization Applications (MAA) submission experience.
• Hands-on experience successfully developing, registering, and supporting compounds throughout their lifecycle.
• Regulatory experience; significant interaction with health authorities within and outside of the U.S. (FDA, EMA, PMDA, etc.)
• Hands-on experience managing multiple therapeutic areas and/or compounds.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• 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.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Nice-to-haves
• Global experience.
• Experience working in rare/orphan disease research.

Benefits
• In addition to base salary, PTC employees are also eligible for short- and long-term incentives.
• All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.