Vice President, Clinical Operations

Job Description Summary:
The Vice President, Clinical Operations is responsible for providing strategic and operational leadership to the success and operational excellence of PTC's clinical stage programs. This involves ensuring that PTC's clinical stage programs achieve program objectives within established timelines and financial investments. The incumbent is responsible for providing strategic direction and manages internal Clinical Operations staff and relationships with external partners to ensure that timelines and deliverables are met.
The incumbent works cross-functionally with internal departments and external resources on Clinical Operations and Project Management related issues.
The Vice President, Clinical Operations 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 to, and leads and directs, the Clinical Operations team responsible for management and execution of clinical trials. This includes, but is not limited to: ensuring cost, quality and timeliness of multiple programs across therapeutic areas.
• Working in a matrix organization ensures that study objectives are in line with the clinical development strategy and the overall corporate strategy.
• Leads and directs recruiting, development, training, and retention of the Clinical Operations team; ensures prioritization of activities and resourcing is in line with clinical development programs. Drives for operational excellence; fosters a collaborative, highly integrated culture.
• Collaborates with, and directs, internal and external medical, scientific and operational experts to keep abreast of industry standards; provides Clinical Operations strategic and technical perspective to decisions.
• Ensures that external vendors are selected and managed to deliver within established timelines and financial investment.
• Partners and collaborates with Clinical Informatics in the design, implementation, and standard use of clinical technology to streamline communication, improve decision making while ensuring operational efficiency and quality.
• Drives the creation of department standards, systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
• Works collaboratively in team environment with Clinical, Product Development, Biostatistics, Regulatory Affairs, Informatics, Legal, Finance departments, and project teams as needed to support clinical programs.
• Contributes to business development activities. This includes providing critical due diligence and analysis of programs.
• Manages, coaches and mentors direct reports.
• Implements, manages and oversees special projects as assigned by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.

• Bachelor's degree in a scientific discipline and a minimum of 10 years progressively responsible experience in clinical drug development (minimum of 7 years in a Clinical Operations management role) in a pharmaceutical, biotechnical, clinical research organization (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.

• Excellent, hands-on Clinical Operations leadership experience across all phases of the clinical development life cycle.
• Thorough working knowledge across a broad range of therapeutic areas.
• Extensive hands-on experience developing high performing Clinical Operations teams.
• Demonstrated ability to optimize the relationships with, and contributions of, Clinical Research Organizations (CROs). This includes, but may not be limited to, ensuring CROs are aligned with and accountable for meeting timelines, deliverables, and cost objectives.
• Regulatory experience; significant interaction with health authorities within and outside of the U.S. (Food and Drug Administration (FDA), European Medicines Agency (EMA), etc.).
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• 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.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience working in rare/orphan diseases.
• Experience with investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
• Field monitoring and/or clinical data management experience.

* Travel requirements

• 10-20%

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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.
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