Director - North America Medical Affairs

Hikma Pharmaceuticals USA Inc.•Columbus, OH

3d•Hybrid

About The Position

Hikma Pharmaceuticals USA Inc. is seeking a talented and motivated Director, North America Medical Affairs to lead the North American (U.S. and Canada) Medical Affairs function. This role serves as Hikma’s independent scientific and clinical voice across the entire U.S. and Canadian portfolio, managing the lifecycle from pre-approval through post-approval. The position acts as a strategic bridge between internal departments (R&D, Regulatory Affairs, Pharmacovigilance, Quality, Commercial, Legal, Compliance) and external stakeholders including healthcare professionals, payers, medical boards, policy decision makers, and patient advocacy groups. The role oversees a growing footprint, including current in-house medical science liaison (MSL) coverage and upcoming launch programs requiring an MSL field team of approximately 1-5 professionals. This role will guide, train, and govern all Medical Affairs personnel to ensure adherence to scientific, regulatory, and conduct standards. While understanding commercial targets, the role drives Medical Affairs success exclusively through non-promotional scientific education and awareness building, operating independently of Commercial teams in accordance with regulatory expectations, with no sales metrics tied to performance.

Requirements

Advanced scientific or clinical degree (MD, PharmD, or PhD).
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.
Executive scientific judgment and communication.
Strong people leadership across FTE and contractor teams.
Deep understanding of U.S. regulatory and compliance frameworks.
Ability to lead in complex, matrixed environments.

Nice To Haves

Relevant board certification preferred (e.g., BCMAS).
Canadian pharmaceutical/biotech Medical Affairs experience is preferred.
Experience in Canadian regulatory and compliance frameworks is preferred.

Responsibilities

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.
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).
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.
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.
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.
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.
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.
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.
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.
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.

Benefits

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave