Associate Director, Diagnostic Biomarker Europe

**Summary**

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. This role enables appropriate testing in order to identify patients with unmet needs who may benefit from available treatment options.

**Duties and 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.

**Requirements**:

- 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)