Job Description

General Summary:

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.

Key Duties and Responsibilities:

Medical Strategy

• 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

• Expertly distills insights and actionable outcomes that inform strategy and drive the greatest impact for Medical Affairs

• Establishes and tracks medical KPIs that demonstrate impact on asset strategy and patient outcomes.

• Applies structured problem-solving and root cause analysis to identify solutions and make decisions that maximize medical and asset strategy impact

• Able to 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

Scientific Excellence

• 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

• Able to 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

External Partnerships

• Represent Vertex at scientific and medical forums, including medical education forums, scientific societies, patient advocacy groups, and congresses.

• Accountable for engaging and cultivating professional relationships with leading global key thought leaders (TL) to gain greater understanding of the disease area, and insights into unmet patient needs

Medical Communication

• Tailors 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

Regional Medical and Cross Functional Collaboration

• 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.

• Medical Affairs leader on key global cross-functional product and development strategic focused teams, including DST and relevant sub teams

• Effectively represents and communicates DST priorities to the medical function and proactively communicates and represents 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 relevant 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.

Evidence Generation and Access

• 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

Team/People Management

• 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

• Leverages the capabilities and expertise of the team to ensure successful execution of medical plans

• Identifies and addresses team skill gaps, considering how to accelerate internal talent or attract external to meet needs of a future-ready organization.

• Adheres to formal goal-setting, talent and performance cycles ensuring individual development plans (IDPs) are in place

• Navigates ambiguous or rapidly evolving situations, and coach the team during periods of uncertainty or change.

Compliance and Pharmacovigilance:

• 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

Education and Experience:

• 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

Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]