Overview
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.
Office based + Remote (Minimum 3-4 days weekly in Dublin HQ)
Employment Type: Full time – Employed
Experience Background: 7+ Years working in operational support and operational management positions in conjunction with European Medical Affairs and Clinical Operations.
Highly desired: Rare/Orphan Disease portfolios + Wider EU build to launch operational experience
A competitive salary and benefits will be on offer.
Responsibilities
* 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.
* Build operational capabilities, ensuring launch readiness, scientific engagement, and real-world data generation in alignment with the associated rare disease community needs.
* Lead the Operational pathways, ensuring trajectories are aligned, mapped and rolled out for all related business operational needs for the Medical Affairs team in Europe.
* Lead tasks to optimise operational infrastructure and strategic initiatives that support the Medical Affairs team, including process improvements, systems implementation, and activity compliance across therapeutic areas and planned European launch markets.
* Coordinate medical affairs activities: Publications, Congress sponsorships, 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.
* Integrate data systems that support scientific exchange tracking, field insights, KPI dashboards and metrics dashboards for MSLs.
* Provide experience with Medical Systems & Technology enablement: CRM platforms (e.g., Veeva Medical), materials review, medical publications review, medical inquiry systems, publication management tools and metrics dashboards.
Qualifications & Requirements
* Required:
* EU Citizen – Ideally resident in Ireland, and located within commute distance to Dublin office.
* Potential consideration for EU citizens willing to self-relocate to Ireland and be located in Dublin or nearby areas.
* Experience in a senior medical operations focused position: 5+ years.
* Language skills: English; additional languages beneficial but not essential.
Preferred / Desirable experience
* Experience in Innovative Biotech/Biopharma and smaller build out / start-up groups – Highly beneficial.
* Experience managing operational systems and processes with setup, compliance and governance.
* Ability to implement robust data tools and tracking/reporting methods for forecasting and real-time variance management.
* Support for day-to-day activities including tracking and visualization of data and data reports.
* Experience with Medical Communications and related Medical Operations activities.
* Facilitate and support coordination of medical affairs activities: Publications, Congress & sponsorships, Symposia, Advisory boards, patient advocacy and KOL engagements.
* Ensure regulatory, ethical, and compliance standards are met across European markets.
* Experience integrating data systems that support scientific exchange tracking, field insights, KPI dashboards for MSLs.
* Proven Medical Systems & Technology enablement: CRM platforms, Veeva Medical, publications review, medical inquiry systems, publication management tools and metrics dashboards.
* Rare/Orphan Disease portfolios involvement in early-stage settings plus builds to launch and commercialization (desirable but not essential).
* Background in Endocrinology / Obesity / Psychiatry / Genetic Disorders and Metabolic Disease (beneficial but not essential).
* Strong self-leading attributes and collaborative, agile problem-solving approach.
* Adaptable to fast-paced and evolving work environment.
To Apply
In the first instance please send your CV and any relevant support details for consideration.
Details
* Seniority level: Director
* Employment type: Full-time
* Job function: Research and Science
* Industries: Biotechnology Research and Pharmaceutical Manufacturing
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