Manager, Global Medical Affairs Operations

The Manager, Global Medical Affairs Operations will work collaboratively to manage the administration and execution of the PTC Investigator Initiated Studies (IIS) program, the PTC Access to Therapies (ACTs) program and global diagnostic programs. This position will also collaborate with relevant internal stakeholders to administer the GMA Operations global budget and manage key vendor relationships. He/she will provide insight to optimize resources and provides strategic insights while working closely with global/regional teams. The Manager, Global Medical Affairs Operations adheres to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities

• Drives the GMA operational component of cross-functional project teams and works with Product Owners and General Managers to determine and translate business requirements into solutions.
• Works effectively within the GMA team (GSA, Registry Operations, and the field teams) to ensure that any required operational support is provided as needed.
• Management & coordination or Investigator Initiated Studies (IIS) program with aligned Areas of Interest to PTC and GMA strategy/focus areas.
• Develops, manages, and maintains strategy and processes for IIS and collaborative research, approvals, contracting, and ongoing tracking/management.
• Manage IIS Operations– Developing and managing processes for IIS submissions, approvals, contracting, and ongoing tracking/management
• Responsible for regular reporting on IIS program insights.
• PTC ACTs program execution through a partnership with therapeutic leads and regional leads.
• Developing and managing approaches and processes for ACTS submissions, approvals, contracting, and ongoing tracking/management.
• Works with compliance, legal, and regulatory to define access approaches and processes.
• Provides support of clinical trial patients on request by Clinical Development teams; collaborates and provides support to other departments as needed within the program.
• Manages ACTs Operations– Developing and managing processes for ACTs submissions, approvals, contracting, and ongoing tracking/management
• Responsible for regular reporting on ACTs program insights.
• Works with global and regional teams to facilitate the use of existing tools and/or build new capabilities to meet any unique needs and requirements around patient finding.
• Supports patient identification/finding through developing, maintaining, and supporting strategically aligned tools and platforms.
• Identifies maintains and supports new and existing laboratory relationships in conjunction with the regional field teams.
• Partners with regional teams to develop, initiate, and execute testing programs – develop approach, facilitate internal processes, contracting, facilitating distribution/collection of screening tests/kits.
• Provides strategic guidance through data-based insights around patient identification for current and future indications - including owning and sharing meaningful dashboards.
• Enables patient identification/ finding through developing, maintaining and supporting strategically aligned tools and platforms – Working with global and regional teams to facilitate the use of existing tools and/or build new capabilities to meet any unique needs and requirements around patient finding.
• Patient Screening Dashboard, data collection, and maintenance with oversight.
• Supports forecasting requests for testing, and utilization across all regions
• Maintains dashboard to capture information about our testing program so that we can do a global assessment to provide insights on.
• Oversight and management of GMA Operations Budget.
• Builds and maintains a comprehensive understanding of all ongoing projects and vendor/laboratory relationships; including but not limited to genetic testing laboratories and investigator-initiated studies (IIS).
• Maintains an open and constant line of communication with the internal owners/users of these projects (Medical directors, CSDs, etc) to identify any issues and working to quickly provide solutions.
• Ensures alignment with finance business partners to communicate budget changes or needs.
• Continuously reviews current processes, identifying any gaps, and providing recommendations to improve or define new operational strategies.
• Engages regularly with all project leads, stakeholders, and internal/external team members to define and document business processes/needs, identify appropriate solutions.
• Performs other tasks and assignments as needed and specified by management.

Qualifications

• Bachelor’s or Master’s degree in Biology, Pharmacy, Chemistry, Life Sciences, Analytical or related scientific discipline and minimum of 3 years of progressively responsible experience in Medical Affairs OR equivalent experience and/or education.
• Receive feedback and apply this to continuous improvements in quality output, develop capabilities for innovation and service excellence.
• Ability to take initiative and understand tasks quickly with minimal supervision.
• Must be comfortable working with demanding stakeholders under stressful conditions while presenting a positive image in meeting and work sessions.
• Acts independently with good judgment, when needed.
• Ability to professionally interact with all levels of the organization.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Understanding of the pharmaceutical, biotechnology or related environment.
• Proficiency with Microsoft Office Suite (Excel and PowerPoint).
• Excellent verbal and written communication and skills (PowerPoint).
• Travel requirements: 10-20% (domestic and/or international).