Executive Director/Vice President, Global Operations and Medical Excellence (ED/VP, GOME)

Medical Affairs /
Full Time /
The ED/VP, GOME will work with the SVP, Global Medical Affairs and the broader global medical affairs leadership as a leader and manager driving strategy and operations related to GMA core or work functions.  This position is responsible for oversight and ensuring continued empowerment of our subject matter expertise, delivery of high quality and impactful work products and focus on innovative, best-in-class, value-add services and deliverables by GMA. 
The ED/VP, GOME will develop and oversee a comprehensive operations function to support global medical affairs work both in the US and outside the US, including all work functions: (1) global HQ, including Sci Com - publications, medical information and med ed - HEOR, the medical director group – advisory boards, medical strategy, MLR and PRC,  content and training, medical research; (2) Ex-US functions and (3) US Field functions.  This will include all needed project management, vendor assessment, contracting and management, systems assessment, implementation and management,  (in partnership with IT), reporting and analytics, meeting planning and execution, medical affairs planning process, budget management and reporting.

The ED/VP, GOME will establish and maintain processes and appropriate control documents (e.g., policies, SOPs and business rules) for all key functions in GMA, working in conjunction with the process and work function owners, The ED/VP, GOME will maintain timelines for project deliverables and ensure proper, compliant completion of all projects.   The ED/VP, GOME will maintain current awareness of all applicable regulatory guidelines in all applicable markets and maintain detailed records on the progress of projects and support audit-ready documentation

The ED/VP, GOME will evaluate department timelines, organization of project deliverables, and the alignment with cross-functional internal partners.
The ED/VP, GOME will identify necessary capabilities to deliver on the above, develop appropriate job descriptions and/or contractor role descriptions, hire appropriate people and lead, develop and manage them to deliver a top-quality operations function in medical affairs.


This position is responsible for oversight and ensuring continued empowerment of our subject matter expertise, delivery of high quality and impactful work products and focus on innovative, best-in-class, value-add services and deliverables by GMA

Specific activities within the oversight of this role include, but are not limited to, strategic planning, operations execution, budgeting, strategic sourcing and vendor engagement, governance, policy and compliance, internal and external communications and process improvements

This individual will also identify process gaps within GMA and ensure the correct processes are in place in accordance with Madrigal’s strategic priorities across regions and aligned with other Madrigal departments

This individual will also help drive strategic direction along with other functional partners and execute on the agreed-to strategy, including collaborating cross-functionally with commercial and R&D stakeholders (and other functions) to develop and execute on the annual medical operating plans

Work in a leadership and management capacity for GMA team to implement customer strategies aligned with scientific exchange, clinical and medical education, data dissemination, medical research, publications, medical information management and other GMA deliverables

Work with GMA team to set strategic priorities to identify leadership focus areas and set metrics for success

Provide direct management and leadership of the GMA Operations and Medical Excellence team member(s)

Responsible for supporting strategic direction and development, facilitating strategic planning, driving implementation, and providing ongoing management

Develop and support the insights/learning gathering, synthesis and reporting capabilities of GMA to help inform organizational decisions and strategy

Provide continuous assessment of GMA capabilities, processes and systems to identify gaps and opportunities to maximize value and increase operational efficiency, informed both by internal and external landscape assessments

Analyze and make recommendations related to emerging industry trends, expansion opportunities, competitive dynamics and internal business performance improvement

Drive a culture of transparency, collaboration and accountability within GMA, through structured weekly LT engagements and progress sharing including the facilitation of cross-functional updates within the medical organization

Drive and support evaluation, implementation and maintenance of appropriate governance, systems, and processes to facilitate medical excellence to enhance collaboration and transparency across GMA – e.g., MPT, Medical CRM and medical collaborative environments

Support development and design of improvements to policies, processes, quality and other system tools to drive a compliance environment – e.g., grant review committee, FMV and consulting agreements, Transparency reporting, budget/financial management

Support management of contracts for contractors and consultants as appropriate
Develop and maintain GMA medical dashboards to ensure appropriate sharing of execution of annual medical operational plans, field tactical plans, budget management and launch plan execution

Provide project management support from within Operations and Medical Excellence for key GMA projects

Develop and manage the communications process to ensure the entire GMA (and other Madrigal stakeholders) are receiving communications from GMA in a timely and organized fashion that is efficient for all end-users

Bachelor Degree required, preferably in the life sciences or in a related field; an advanced degree (eg., MBA, MS, PharmD, PhD) is preferred

10+ years professional experience including at least 4 years leading operations and/or medical excellence for a global medical affairs organization in the pharmaceuticals industry.  Medical Affairs work function leadership experience preferred (e.g., sci com, field medical, medical research leadership)

6+ years of direct people leadership/management experience with a strong record as a people leader

6+ years of budget management for a large, global function

Must have pharmaceutical product launch experience

Strong working knowledge of operations principles, medical affairs work functions and building and implementing global capabilities

Strong understanding of Medical Affairs work functions (e.g., publications, medical information, HEOR, field medical, medical education) and what “state-of-the-art” looks like

Strong understand and applied knowledge of process and quality improvement
Sound knowledge compliance requirements for this both in the US and ex-US (primarily Europe)

Proven organizational skills with experience managing multiple priorities

Candidate will have an in depth knowledge of Medical Affairs organizations, including related operating processes, policies, procedures and regulations

Proven ability to collaborate across organizational boundaries. This position involves strong collaboration with key internal stakeholders including MA leadership and colleagues, R&D leadership and colleagues, IT, Finance, Legal, Compliance and Marketing

Strong written/ verbal communication and listening skills

Strong planning/organizational skills and highly responsive work style

Strong interpersonal skills in developing and maintaining professional relationships

Highly proficient with Microsoft Office suite and IIRs/grants/document management systems, CRM tools, project-management software, SharePoint and other related tools

Solid understanding of financial and legal principles in the pharmaceutical industry

Must be within 50 miles of West Conshohocken, PA – corporate headquarters and able to be in the office 3-4 days week

Travel: Less than 20% (domestic and some international)