Associate Director Diagnostic Biomarker Europe

**Job Summary (Primary function)**

The Associate Director Diagnostic Biomarker, Europe is responsible for the coordination and the local implementation of the biomarker testing strategy in Europe for Targeted Therapies with focus on a Rare Disease Brand. The Associate Director enables appropriate testing in order to identify patients with unmet needs who may benefit from available treatment options.

**Essential Functions of the Job (Key responsibilities)**
- Understand the scientific background, strategic approach, patient journey, business challenges and requirements of the Brand in the context of diagnostic testing requirements.
- Provide continuous educational support to ensure appropriate testing among pathologists, molecular biologists, oncologists, and other stakeholders.
- Provide regular trainings internally about biomarkers, testing techniques used in Oncology and support post-congresses debrief about biomarkers and testing topics
- Support country mapping of diagnostic lab network and testing tactics if needed.
- Support brand marketing/ medical teams by implementing the biomarker testing plans.
- Develop professional relationships with thought leaders, laboratories & healthcare professionals and all stakeholders involved to ensure seamless implementation of local/ European biomarker strategy.
- Engage key pathologists and molecular biologists in Europe to support the company strategy and awareness about specific biomarkers.
- Identify and implement relationships and potentially some collaborations/partnerships with External Quality Assessment (EQA) program in the countries.
- Ensure launch readiness through collaborating with EU country affiliates.
- Develop KPI’s to track launch readiness and successful implementation of key tactics.
- Develop and support the biomarker strategy at pre-launch, launch and beyond.
- Monitor scientific and market environments.
- Ensure ongoing close alignment with current and upcoming new regulations e.g. IVDR regulations.
- Ensure strong support of European Regulatory and Market Access Teams as well as local affiliates.
- Work cross functionally with support functions to ensure company standards are met.
- Ensure adequate reporting of adverse events / technical complaints / compliance issues in accordance with company policies and procedures.
- Ensure compliance with applicable laws and regulations including those relating to personal data protection, scientific communications, biological samples, diagnostic testing, etc.
- 100% timely completion of all training requirements, including compliance.

**Qualifications (Minimal acceptable level of education, work experience, and competency)**
- Scientific Degree (PhD, PharmD, MD) with molecular biology experience ideally focused on oncology, biomarkers and diagnostic testing.
- 3+ years’ experience in a pathology lab or support with direct contact to laboratories or diagnostics.
- 5+ Medical/commercial experience within the oncology field in pharmaceutical or diagnostic industry.
- Understanding of the European pathology and IVD landscape.
- In depth understanding of the available tests, Diagnostic Laboratory and Companion Diagnostic/In vitro Diagnostic environment in European countries.
- Good overview and understanding of sample and testing workflow in the clinical diagnostic laboratory; genetics, pathology & cellular pathology.
- Good understanding of the multidisciplinary approach for patients management.
- Be confident in communicating with laboratory professionals and physicians (e.g., oncologists, pathologists, thought leaders).
- Fluent in English.
- Excellent interpersonal, communication, and influencing skills.
- Goal orientated with a determined personality, high level of self-motivation and learning agility.
- Ability to take initiative, exercise good judgment, think laterally and resolve complex issues in a dynamic and changing environment.
- Team oriented and ability to work with autonomy.
- Strong working knowledge of compliance principles applicable to the role including those relating to personal data protection, IVD regulation, scientific communications, etc.
- Experience in targeted therapies and/or rare diseases would be a plus.
- Readiness to travel across Europe as required (around 50% of time).

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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