Director/Senior Director - Medical Information
Full-timeSenior · 15+ yearsH1B likely
About this role
Why this role exists
We are seeking a Director, Medical Information to support the delivery and continued evolution of our Medical Information services. This role will be responsible for providing strategic oversight of sponsor accounts, ensuring high-quality and compliant MI operations, and contributing to process excellence and functional growth within a growing organisation.
The position offers the opportunity to work closely with leadership, cross-functional teams, and clients, while helping shape scalable and efficient ways of working across the MI function.
Why this matters for you
This role is ideal for someone looking to take on broad operational responsibility and contribute beyond day-to- day delivery.
In this role, you will:
- Provide strategic oversight of sponsor accounts with end-to-end accountability for Medical Information activities
- Drive team growth, capability development, and operational excellence
- Lead process improvements, SOP development, and technology-enabled solutions
- Partner with internal stakeholders during program planning and business discussions
- Apply your Pharmacovigilance (PV) experience to support effective collaboration across MI and PV activities
What you will own
Service delivery and client ownership
- Lead end-to-end MI delivery for assigned sponsor clients, ensuring adherence to contractual SLAs, applicable regulations, and global guidance
- Act as the primary point of accountability for quality, timelines, and compliance across your portfolio
- Handle and oversee medical enquiries from HCPs, patients, consumers, and other stakeholders across phone, email, and other channels, including non-IST coverage where required
- Own quality control of MI responses, escalations, and adverse event and product complaint handoffs to PV and Quality
Function building and team leadership
- Lead and mentor a growing MI team, with a clear mandate to scale and shape the function
- Recruit, onboard, coach, and develop MI Associates and Specialists
- Identify skill gaps, design training plans, and elevate the technical and scientific capability of the team
- Oversee workload distribution and proactively escalate risks before they impact quality or delivery
Content, systems, and continuous improvement
- Author and review SOPs, work instructions, and controlled documents for the MI function
- Lead development and lifecycle management of Standard Response Documents, FAQs, and global content libraries
- Oversee MI project setup, database configuration, validation, and onboarding for new client engagements
- Contribute to how we use technology, automation, and AI to make MI delivery faster and better, without compromising scientific rigour
Compliance, audits, and stakeholder engagement
- Represent the MI function during sponsor audits, regulatory inspections, and internal quality reviews
- Maintain a strong compliance posture across documentation, training, and CAPA
- Partner with PV, Quality, Regulatory, and Commercial teams internally, and with sponsor Medical Affairs counterparts externally
What we are looking for
Experience
- 15+ years in life sciences, with demonstrable depth in Medical Information, Pharmacovigilance, or a combination of both
- Prior MI management or MI team-lead exposure in a CRO, pharma, or biotech setting
- Track record of managing client relationships, SLAs, and audit readiness, ideally across multiple sponsors or therapy areas
- Experience handling medical enquiries across global markets and time zones
Skills and qualifications
- Life sciences or pharmacy degree; PharmD, MPharm, or equivalent advanced qualification preferred
- Strong working knowledge of MI and PV regulations, ICH guidelines, and global pharmacovigilance frameworks
- Comfortable authoring SOPs and controlled documentation
- Hands-on familiarity with MI databases and content management systems
How you operate
- You take ownership and do not wait to be told what to escalate
- You hold a quality bar without becoming a bottleneck
- You can coach a junior associate one hour and brief a sponsor lead the next
- You are curious about where the function is going, not just how it runs today
What we offer
- A clear and visible leadership career path, with continued growth opportunities as the function expands
- Direct exposure to leadership, clients, and the commercial side of the business
- The opportunity to build and shape a team rather than simply maintain one
- Competitive compensation, with structured performance reviews and growth planning
- Flexibility on working arrangements where the role permits