Executive Medical Director, Global Medical (Nephrology)

Vertex Inc.•Boston, MA

1d•$328,000 - $492,000•Hybrid

About The Position

The Executive Medical Director, Global Medical Lead (GML), IgA Nephropathy is a critical leadership role in Global Medical, responsible for the global medical strategy and implementation and tracking of global activities for a designated disease area(s). Key accountabilities include, but are not limited to, disease area specific Integrated Medical Plan development, including the publication plan, integrated evidence generation plan, global medical launch strategy and execution, scientific leadership, external medical expert engagement, and strategic alignment with commercial and other cross-functional business partners. This leader reports directly to the VP, Global Medical and is a core member of the Global Medical leadership team. They will lead the global medical affairs team for the designated disease area(s) and represents Medical Affairs in all Global strategic teams with Development and Commercial, including the Disease Strategy Team (DST) to drive cross-functional alignment, anticipate future needs, and contribute to Medical Affairs and Vertex’s long-term success.

Requirements

MD (preferred), PhD, PharmD or other advanced life sciences degree required
Typically requires 10 years of experience and 5 years of supervisory/management experience or the equivalent combination of education and experience
6 or more years of relevant leadership experience in medical affairs and/or clinical development, including experience in both Global and Country/Region desired
2 or more years of industry experience in disease area or 2 or more years of clinical / academic experience in disease area

Responsibilities

Lead the development, implementation, execution, and communication of the Integrated Medical Plans, including but not limited to medical strategy, global tactical plan, publication, congress and evidence generation plans, in collaboration with Clinical Development, Clinical Operations, HEOR, RWE, Medical Writing, and other internal stakeholders across Vertex
Ensure alignment of medical strategy with organizational objectives by integrating individual and disease area team goals with Vertex and DST priorities, and the goals of cross-functional partners
Distill insights and actionable outcomes that inform strategy and drive the greatest impact for Medical Affairs
Establish and track medical KPIs that demonstrate impact on asset strategy and patient outcomes
Apply structured problem-solving and root cause analysis to identify solutions and make decisions that maximize medical and asset strategy impact
Identify what is important and impactful to medical and the wider organization, prioritize competing demands and communication to key stakeholders
Accountable for development of the global DA budget, management of funds allocation, and associated tracking to ensure alignment with Medical Affairs priorities and efficient resource allocation
Serve as product and disease area expert and Global Medical primary contact point for all global disease area related issues with the external community and internally at Vertex
Lead development of peer reviewed publications, congress presentations and evidence generation to inform clinical practice
Lead the development of global scientific communications and materials including materials for global led symposia, advisory boards, and training
Accountable for medical review of assigned brand related content and global medical content aligned with Vertex SOPs
Represent Vertex at scientific and medical forums, including medical education forums, scientific societies, patient advocacy groups, and congresses
Engage and cultivate professional relationships with leading global key thought leaders (TL) to gain greater understanding of the disease area, and insights into unmet patient needs
Tailor communication to stakeholder needs, building trust and understanding across diverse audiences
Deliver external presentations (advisory board meetings, symposia, other medical education meetings) to enhance the medical knowledge of pipeline and marketed products, as required and in accordance with relevant regulations and procedures
Support disease area training across the company as required
Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for pipeline therapies and marketed medicines
Accountable for the medical component of the go to market model
In absence of regions teams, medical components of the country go to market model remains the responsibility of the GML
Support regional Medical Affairs and Medical Excellence teams from launch through lifecycle via timely delivery of fit-for-purpose training and core materials
Responsible for driving alignment on medical content/messaging within the organization to ensure maximal functional and regional input
Act as Medical Affairs leader on key global cross-functional product and development strategic focused teams, including DST and relevant sub teams
Effectively represent and communicate DST priorities to the medical function and proactively communicate and represent medical needs to DST
Chair the Global Medical Area Team (GMAT) for the disease area and accountable for deliverables
Provide strategic Medical Affairs leadership on key commercial teams: Launch Team, and Global brand teams for product
Represent Medical Affairs in label discussions
Support Access, Patient Advocacy, Policy, and Corporate Communications teams with medical/scientific expertise and materials review
Accountable for the strategy, development and execution of Life Cycle Management studies in partnership with HEOR, including Integrated Evidence Generation plan in close collaboration with key internal stakeholders
May act as medical monitor for studies falling under the Medical Affairs scope in collaboration with Clinical Development, Real World Evidence, Health Economics and Outcomes Research, and Clinical Operations
Lead oversight and management of ISS programs, and in collaboration with Regional Medical leadership, conduct critical scientific and medical review of ISS protocols
As applicable, lead Managed Access Committee for assets with a Managed Access Program (MAP); may act as a Medical Monitor for MAP
Provide strong leadership to dedicated disease area medical team, inspiring and empowering a dedicated medical team, and promoting a culture of continuous development
Accountable for the recruitment, development, management and coaching the DA global medical team
Leverage the capabilities and expertise of the team to ensure successful execution of medical plans
Identify and address team skill gaps, considering how to accelerate internal talent or attract external to meet needs of a future-ready organization
Adhere to formal goal-setting, talent and performance cycles ensuring individual development plans (IDPs) are in place
Navigate ambiguous or rapidly evolving situations, and coach the team during periods of uncertainty or change
Ensure compliance of medical activities according to global and regional guidelines and in accordance with Vertex Code of Conduct, rules and regulations, company policies, SOPs, GCP and ICH
Ensure self and other medical colleagues have the required skills to identify and report AEs appropriately
Contribute to managing external communication when significant safety issues arise, with the wellbeing of patients being the ultimate goal