Director - North America Medical Affairs (Berkeley Heights)
Director - North America Medical Affairs Job Title: Director, North America Medical Affairs Location: Berkeley Heights NJ or Columbus, OH Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500 employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them. Overview We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Director, North America Medical Affairs to join our team. In this role, you will be responsible for leading the North American (U.S. and Canada) Medical Affairs function as Hikma’s independent scientific and clinical voice across the entire U.S. and Canadian portfolio, from pre‑approval through post‑approval lifecycle management. The role serves as the strategic bridge between Hikma’s R&D, Regulatory Affairs, Pharmacovigilance, Quality, Commercial, Legal, and Compliance on the one hand and the external community of healthcare professionals, pharmacies, payers and insurers, medical boards and professional societies, health‑system and policy decision makers, and patient advocacy groups on the other. The role oversees a focused but rapidly expanding footprint, including current in‑house medical science liaison (MSL) coverage supporting an established hospital injectable product and upcoming launch programs requiring an MSL field team of approximately 1–5 professionals. This role will, in line with Hikma, guide, train, govern, and hold accountable all Medical Affairs personnel (Hikma FTEs and agency‑contracted personnel alike) to a single set of scientific, regulatory, and conduct standards. The role understands Commercial targets and goals and uses that context to inform Medical Affairs coverage, capacity, and scientific priorities, while driving Medical Affairs and MSL success exclusively through non‑promotional scientific education and awareness building. This role operates independently of Hikma’s Commercial teams in accordance with FDA, Health Canada, OIG/DOJ, and PhRMA Code expectations and, as such, no sales metrics are tied to this role or its performance. Key Responsibilities 4.1 Medical Affairs Strategy and Independence Lead the North American (U.S. and Canada) Medical Affairs strategy across all therapeutic areas and product classes, including medical vision, strategic objectives, evidence‑generation portfolio, key opinion leader engagement, and resource plan Support the positioning of Medical Affairs as a strategic pillar on par with R&D and Commercial in shaping product strategy and the external scientific narrative Set Medical Affairs priorities based on scientific need and stakeholder impact 4.2 Talent Build: Hiring FTEs and Contracted Personnel Own the North American (U.S. and Canada) Medical Affairs workforce strategy across Hikma FTEs and contracted agency personnel, including MSLs, medical writers, and medical information specialists Retain sole Medical Affairs decision rights over selection, scope, training prerequisites, and, in coordination with Hikma’s People Function and the Legal Department, performance management and termination Manage build‑vs‑partner decisions, including current in‑house MSL coverage and upcoming launch‑program MSL build Establish compliant performance measures based on scientific exchange and insight quality only (no sales metrics) 4.3 Training, Certification, and Regulatory Alignment Own and oversee onboarding, certification, and annual recertification for all Medical Affairs personnel (FTEs and contractors). Ensure alignment with FDA/FDCA, OIG/DOJ, PhRMA Code, Sunshine Act/Open Payments, Anti‑Kickback Statute, HIPAA, applicable Canadian laws as well as guidelines provided by Health Canada, and Hikma policies Maintain audit‑ready documentation, training records, and compliance attestations 4.4 MSL Organization and Stakeholder Coverage Establish and maintain strong relationships with key opinion leaders, healthcare professionals, and other relevant stakeholders in the U.S. and Canadian markets Understand Commercial targets and goals to inform coverage capacity, therapeutic‑area allocation, and geographic deployment, while directing MSL execution exclusively toward non‑promotional scientific education Own the MSL function strategy, organizational design, capability model, hiring plan, performance management, and succession planning Lead MSL engagement across the full external decision‑maker ecosystem: HCPs, pharmacies and P&T committees, payers and insurers, medical boards and professional societies, health‑system and policy decision makers, and patient advocacy organizations 4.5 Medical Writing and Scientific Communications Own publication strategy, scientific platforms, congress strategy, and authorship governance across the portfolio Own accuracy, fair balance, and scientific integrity of all Medical Affairs‑originated content, whether produced by Hikma FTEs or contracted writers and agencies 4.6 Labelling, Prescribing Information, and Package Insert Lifecycle Partner with Regulatory Affairs, Clinical Development, PV, and Legal on North American (U.S. and Canada) labeling content across Hikma’s branded as well as, more generally, non‑injectable and injectable products Provide medical and clinical interpretation underpinning labeling positions and ensure fair balance with the underlying clinical or bioequivalence dataset Translate labeling positions into North American (U.S. and Canada) Core Medical Content so MSL tools, medical information responses, and scientific platforms remain synchronized with current PI 4.7 Medical and Scientific Support Partner with Clinical Development, PV, R&D, and Regulatory Affairs on integrated safety summary (ISS) and integrated summary of efficacy/effectiveness (ISE/ISC) for branded programs Ensure consistency of ISS/ISE‑derived content using external publications, scientific platforms, advisory board materials, payer dossiers, and field training Provide medical and scientific support to Quality, PV, R&D, Regulatory, Commercial, Legal and Compliance functions as needed 4.8 Promotional Review (PRC/MLR) Leadership; Governance, Compliance, and Audit Readiness Serve as senior Medical Affairs voting member of the U.S., and where applicable Canadian, promotional review committee/medical, legal, and regulatory (PRC/MLR), with independent veto authority on scientific accuracy, fair balance, and on‑label conformance Own Medical Affairs review standards aligned to the most current U.S. and Canadian prescribing information (PI) and ISS/ISE positions Lead PRC/MLR charter, standard operating procedures (SOPs), review service level agreements (SLAs), and escalation pathway with Regulatory Affairs and Legal 4.9 Real‑World Evidence, HEOR, and Value Generation Support real‑world evidence, health economics and outcomes research (HEOR), and investigator‑initiated research aligned to scientific and stakeholder needs Advise payer and pharmacy scientific engagement through compliant, evidence‑based communication 4.10 Additional Governance, Compliance, and Audit Readiness Maintain Medical Affairs review standards and escalation pathways Own related SOPs and policies and, as appropriate in coordination with other functions, support in reviewing and updating such policies and SOPs Qualifications Advanced scientific or clinical degree (MD, PharmD, or PhD). Relevant board certification preferred (e.g., BCMAS). 12 years U.S. pharmaceutical/biotech Medical Affairs experience. 5 years in senior leadership roles overseeing MSLs and medical functions. Experience across multiple therapeutic areas and product classes (branded as well as generic injectable and non‑injectable products). Demonstrated leadership in PRC/MLR, labeling support, and evidence generation. Proven experience managing contracted Medical Affairs resources. Canadian pharmaceutical/biotech Medical Affairs experience is preferred. Executive scientific judgment and communication. Strong people leadership across FTE and contractor teams. Deep understanding of U.S. regulatory and compliance frameworks; experience in Canadian regulatory and compliance frameworks is preferred. Ability to lead in complex, matrixed environments. Significant travel expected to support commercial and operational needs. Compensation Base Salary: $121,000 to $220,000 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job‑related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide
