Director, Medical Affairs Operations

Serving the Global Medical Affairs group, the Director of GMA Operations ensures a strategic leadership focus for efficient and effective GMA operations. The Director serves as an integral component of the Global Medical Affairs Team with a focus on direction and oversight for strategic and tactical operational planning, financial management, and process documentation and improvement.
Providing operational leadership and support to the Global Medical Affairs department, the Director oversees the operational conduct of strategic GMA sanctioned projects. The Director of GMA Operations will establish objectives for the successful completion of projects within prescribed time frames and funding parameters ensuring that appropriate and compliant operational standards and processes are followed globally.

Responsibilities:

Oversee operational support of Shire HGT GMA sanctioned activities including vendor contracting and management, aggregate spend and disclosure reporting, outcome surveys, global grant programs, expanded patient access programs, and IST's involving Shire HGT products. Work with internal GMA stakeholders to ensure that the GMA operational conduct of these activities is aligned with GMA and franchise objectives and embodies a customer relations focus. Lead the development of the strategies that facilitate and maintain efficient and cost effective GMA operational processes impacting Medical Directors, GMA Field Teams, GMA Strategic Services, Commercial Operations and external stakeholders.

Oversee the strategy for GMA Operations process and training standards; identify planning tools; and analyze performance metrics to achieve excellence in GMA operations. Lead the vision for recruiting, hiring and training regional GMA Operations teams. Ensure GMA Operations job specific standards, processes, and associated operational training platforms are implemented globally with a high level of compliance. Drive implementation with the support of the GMA Operations staff to achieve expeditious results, more economically and effectively in cooperation with key stakeholders in GMA and throughout the organization.

As the regional lead for the global grant committee, provide strategic operational input to the grant committee while overseeing the Operations Associate Director/Project Manager to guide the operational tracking, process and overall grant management system via a direct report.

In collaboration with the GMA Operations Associate Director and R&D Finance Business Operations Manager, support franchise aligned management of GMA budget and forecasting processes associated with GMA operational activities.

Provide leadership and mentoring of direct reports.

Education & Experience Requirements:

BA or BS required; Master's preferred
Minimum 8-10 years medical affairs operations/clinical research experience in pharmaceutical or biotechnology field
Experience in Medical Affairs highly preferred
Understands the commercialization process and has an appreciation for both Sales, Marketing and Medical initiatives
A deep understanding of legal/regulatory requirements and codes of practice/guidelines related to Medical Affairs is required.
A strong understanding of principles of Good Clinical Practice (GCP/ICH) and local regulations is required
Strong ability to effectively communicate (oral and written)

Key Skills and Competencies:

Strong knowledge of the drug development process
Demonstrated ability to forge relationships with KOL's
Commitment to quality focused and driven customer service
Understands matrix environments and team player capabilities
Ability to create a departmental vision while leading and building effective operations teams
High degree of management competencies with emphasis on coaching, empowerment, accountability
Understands how to effectively manage conflict resolution
Demonstrated record of proficient project management skills
Excellent judgment and decision making skills
Demonstrated organizational and negotiation skills
Demonstrated budgeting, forecasting and fiscal management skills
Strong organizational awareness and aptitude
International experience
Commitment to strategic goal setting, tracking and reporting performance metrics
Strong interpersonal, organizational, written and oral communications skills
Ability to work in a team environment under high pressure situations
Able to prioritize and delegate the management of projects
Manages multiple projects effectively and efficiently
Proficient with Microsoft Office

Complexity and Problem Solving:

Decision making and operating within the scope of regulatory & legal requirements necessary to form the basis of outcome survey and grant administration procedures and policies

Must be able to assess multiple tasks and projects, identify priorities and manage deliverables
Commitment to ethical, equitable and scientific standards with input from manager when dealing with sensitive, high visibility company matters
Will collaborate with commercial operations and clinical research teams, as required with regard to key operations projects and educational programs

Must be able to prioritize requests for information and seek direction from manager as appropriate

Internal and External Contacts:

Need to communicate routinely and effectively with VP GMA, Franchise Medical Affairs Leads, Commercial Operations, Sr. Regional Medical Affairs Leads, and other GMA medical personnel. Interactions may also include a wide variety of internal stakeholders:
members of Global and Regional Grant Committees, and legal, compliance and R&D staff.

External interactions will include investigators and site personnel, consultants, academic and medical/scientific professionals.

Other Requirements:

25-30% Travel