Director - North America Medical Affairs

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.
Description: 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 (PV), 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 15 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:

Medical Affairs Strategy and Independence
Talent Build: Hiring FTEs and Contracted Personnel
Training, Certification, and Regulatory Alignment
MSL Organization and Stakeholder Coverage
Medical Writing and Scientific Communications
Labelling, Prescribing Information, and Package Insert Lifecycle
Medical and Scientific Support
Promotional Review (PRC/MLR) Leadership; Governance, Compliance, and Audit Readiness
Real-World Evidence, HEOR, and Value Generation
Additional Governance, Compliance, and Audit Readiness
Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
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 more details about the specific salary range for the job location during the hiring process.
What We Offer*:
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
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.