VP, US Medical Affairs

Department: Medical Affairs (MED AFFAIRS)

Category: Medical - Med Affairs

Location: Boston MA Critical Needs. Immediate Action. SERB is a fast-growing global specialty pharma company designed to address rare and urgent conditions by delivering life-saving medicines when time and complexity leave no room for failure. We operate end-to-end across 100+ countries, ensuring 70+ essential medicines for rare diseases, emergency care, and medical countermeasures reach patients and clinicians with urgency – wherever and whenever they are needed. Shaped over the past 25 years by an entrepreneurial, disruptive spirit, SERB combines the focus and agility of a biotech with the scale, reach, and reliability of a global pharmaceutical company — always grounded in medical purpose, not corporate convention. Our 600+ employees are driven by three core values: Patients first, always Patients are not a concept — they are why we act, especially when time matters most. Impact focused We are agile, entrepreneurial, and disciplined - working smart and learning continuously to deliver results that matter, with the consistency, quality, and trust that critical care demands. Team powered We go the extra mile - together - because our shared commitment drives extraordinary outcomes. Guided by a clear ambition and a relentless focus on patients, SERB continues to expand through selective, innovative acquisitions, launching new treatments and entering new geographies. Across every step — from integration to delivery — our people act with passion, ownership, and determination to ensure life-saving medicines become available to patients who need them, worldwide. Broad Overview Eligibility for this position is limited to candidatesresidingonthe East Coast. The Vice President, US Medical Affairs(VP, USMA) is a senior leadership role responsible for setting the strategic direction, execution, operational excellence, and scientific leadership of US Medical Affairs across a broad, multi-therapeutic portfolio. Operating within a highly matrixedorganization, this leader will oversee the development and implementation of medical strategiesdriving high-impact medical executionthat support product launches, lifecycle management, and post-approval evidence generation while ensuring compliance with regulatory, legal, and ethical standards. The VP, USMA serves as a key member of the US leadership team and a critical partner to Commercial, Market Access, Clinical Development, Scientific Affairs, Sci Comms, Regulatory, and PV. The role also requires strong engagementwith key external stakeholders including healthcare professionals, key opinion leaders (KOLs), payers, and professional societies. ThisVP, USMA will bringdeep experience navigating governance, scale, and complexity whilemaintainingscientific integrity, compliance, and patient focus. AsVP, USMA, your responsibilities will include: Medical Leadership& Strategy Lead the US Medical Affairs vision and strategy across multiple therapeutic areas and brands, aligned with global medical, clinical development, regulatory and businessobjectives. Ensure medical plans are evidence-based, patient-centric, aligned withbusiness strategies, and addressesunmet medical needs. Provide scientific and medical leadership across the product portfolio, including marketed products, establishedproductsand assetsin development. Translate global medical strategy into US-specific plans that address local regulatory, payer, and clinical practice needs. Matrix Leadership & Cross-Functional Partnership Provideleadershipwithin a highly matrixed organizationandacross all US Medical Affairs functions, including: Medical Strategy Leads for the all the portfolio Partner closely with Commercial, Market Access, Regulatory, Clinical Development, Safety, Legal, and Compliance to ensure aligned and compliant execution. Portfolio & Launch Excellenceand Life cycle management Oversee US medical support forthe SERBportfolio of marketed products, line extensions, andproduct development. Ensure medical launch readiness at scale, including scientific platform development, field medical deployment, and internal medical training. Drive consistent standards and best practices across brands and therapeutic areas. Support lifecycle management through: Data generation(SERB studies, Investigator-initiatedstudies(IISs), Real-world evidence, HEOR collaborationand post-marketing studies) Medical Education, Publicationsand scientific communications Medical Information (supported by a global service provider) External ScientificEngagementServe as a senior US medical representative to external stakeholders, including national and international KOLs, academic leaders, and professional societies. Build andmaintainstrong relationships with KOLs, academic institutions, professional societies, and other key external stakeholders. Oversee scientific exchangeacross the portfolio, includingadvisory boardsand expert panel meetings. Compliance & Governance Ensure all Medical Affairs activitiescomply withFDA regulations, PhRMA Code, and internal SOPs. Provide medical governance oversight for promotional and non-promotional materials as requiredby company processes. Partner closely with Legal, Regulatory, and Compliance to ensure scientific integrity and risk management. Establish clear operating models, metrics, and governance to ensure quality and impact at scale. Manage budgets and resources effectively to maximize medical impact. People & Organizational Leadership Buildandlead a high-performing US Medical Affairs organizationincluding succession planning and leadership development. Foster a culture of scientific excellence, collaboration, accountability, and continuous improvement. The above duties and responsibilities are not an exhaustive list, and you maybe requiredto undertake any other reasonable duties compatible with your experience and competencies. This description maybe variedfrom time to time to reflect changing business requirements. To be successful in this role, you shoulddemonstrate: EducationMD, PharmD, PhD, or equivalent advanced scientific/medical degreerequired Experience Minimum of 12+ years of experience in the pharmaceutical, biotechnology, or healthcare industry Demonstrated success leading US Medical Affairs orlargemedical organizations. Demonstrated experience supporting US product launches and marketed products. Deep knowledge of FDA regulations, global medical governance, and US healthcare systems Proven medical leadership in complex, matrixed organizations Strategic thinker with strong execution capabilities Proven ability to influence and collaborate cross-functionally at the executive level Excellent scientific, communication, and presentation skills Deep understanding of the US healthcare environment and stakeholder landscape Strong change management and organizational leadership skills. Strong leadership presence with the ability to inspire and develop teams Mustresideon the East Coast

Company Benefits: Hybrid Working Vacation, Personal and Sick time 15 Paid Company Holidays Medical, Dental, Vision and other Voluntary benefits Tuition Assistance Discretionary Bonus Plan Competitive 401(k),$1 for $1 up to 6% of pay. The safe harbour match is vestedimmediately. In addition, SERB also offers a discretionary match of up to 4% of pay which vests 20% a year for 5 years. Serb Pharmaceutical is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.