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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. 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.
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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) 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.
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.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience.
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.
* Special knowledge or skills needed and/or licenses or certificates required.
Regulatory experience; significant interaction with health authorities within and outside of the U.S. (FDA, EMA, PMDA, etc.)
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.
*Special knowledge or skills and/or licenses or certificates preferred.
* Travel requirements
Expected Base Salary Range $425,000 - 485,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. 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. 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. Click here to return to the careers page
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