Director. Medical Affairs Operations
Location: Dublin, Ireland
Office based + Remote (Minimum 3-4 days weekly in Dublin HQ)
Employment Type: Full time – Employed
Experience Background: 7+ Years working in Medical Affairs and Clinical Operations.
Highly desired: Rare/Orphan Disease portfolios + Wider EU build to launch operational experience
Required: PhD / PharmD / bachelor's degree – Life Sciences
Our client, an evolving US HQ Biopharma, is entering an exciting phase of advancement plans for product launch into Europe.
This follows recent commercial success and FDA approval for a Rare Disease and genetic disorder treatment, aimed at transforming patients lives with current unmet need for relative Endocrine conditions including - Obesity, Hyperphagia and associated behavioural issues in both adults and children.
To advance the trajectory and ambitious launch plans for Europe in mid-2026, our client is seeking an innovative, hands on, motivated, and self-leading Director of Medical Affairs Operations to join a new small group of key personnel for Europe, working from the office located in Dublin, Ireland.
The Medical Affairs Operations Director will have oversight for development and further establishment of Medical Affairs systems and processes, to support regional medical excellence, compliance, and cross-functional collaboration. The successful candidate will help build operational capabilities, ensuring launch readiness, scientific engagement, and real-world data generation in alignment with the associated rare disease community needs.
The role will report directly to and work closely and collaboratively with the EU Medical Affairs Lead – Combining skills to ensure the trajectory and pathways are aligned, mapped and rolled out for all operational needs in Europe in build to launch and ongoing through commercialisation.
The Director of Medical Affairs Operations will lead tasks associated to optimise operational infrastructure and strategic initiatives that support the Medical Affairs team. This will include instigating processes and ongoing process improvements, systems implementation, and compliance of activities, to ensure Medical Affairs operates efficiently and compliantly across the associated therapeutic arena and planned European launch markets.
Associated experience sought includes:
* Experience working in Innovative Biotech/Biopharma and smaller build out / start up groups – Highly beneficial
* Experienced in management of operational systems and all associated processes such as - Set up / processes and compliance
* Ability to implement robust data tools and tracking report methods to support forecasting and real-time variance management
* Ongoing support for day-to-day activities including – Tracking and visualisation of data and data reports
* Abilities and credentials to undertake associated responsibilities aligned to – Medical Communications and all aspects of Medical Operations
* Facilitate and support coordination of associated medical affairs activities: Publications / Congress & Congress sponsorship / Symposia / Advisory boards / Patient advocacy engagements and KOL engagement activities
* Ensure Medical Affairs activities across European markets are executed in accordance with local and regional regulatory, ethical, and compliance standards
* Ensure integration of data systems that support scientific exchange tracking, field insights, and KPI dashboards
* Proven Medical Systems & Technology enablement experience: CRM platforms, Veeva Medical, materials review, medical publications review, plus medical inquiry systems, publication management tools and metrics dashboards for MSLs
* Rare/Orphan Disease portfolio's – Involvements in both early-stage settings plus builds to launch and commercialisation – Highly desirable, but not essential
* Beneficial, but not essential – Any associated experience in areas such as: Endocrinology / Endocrine / Obesity / Psychiatry / Genetic Disorders and Metabolic Disease
* Strong self-leading attributes and highly collaborative team ethics approach, combined with being an agile 'solution finder'
* Adaptable to a fast-paced and evolving work environment
Required:
* EU Citizen – Ideally a resident in Ireland, and located within commute distance to the office in Dublin.
* Potential consideration for EU citizens who would be willing to self-relocate to Ireland and be located in Dublin or the near surround areas
* Experience working in industry in a senior medical operative position: 5+ years
* Language skills required – English + Additional languages (Beneficial, but not essential)
The ideal candidate will have a creative and innovative approach to Medical Affairs operations. An additional benefit (but not essential) would be prior direct experience working in an associated medical affairs function – Such as a Medical Science Liaison or Medical Affairs Manager role in earlier career.
You will offer a lead vision and thoughts for direction, combined with a collaborative style of working with the associated medical affairs team and wider EU and US based colleagues.
A success driven attitude to 'making things happen' and driving team success.
A competitive salary and benefits will be on offer.
To Apply
In the first instance please send your CV and any relevant support details for consideration.