Director Global Clinical Affairs- Immunodiagnostics

Vor 7 Tagen

Home Office, Schweiz Thermo Fisher Scientific Vollzeit

**Location: EMEA-Remote**

**Division Summary**:
The **ImmunoDiagnostics Division (IDD)** develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 2,000 employees worldwide, IDD is the global leader in in vitro allergy testing and also the European leader in autoimmunity diagnostics. The allergy and autoimmunity product lines operate on a common automated instrument platform, Phadia Laboratory Systems, which supports both productivity and cost efficiencies in clinical laboratories around the world.

**How you will make an impact?**

The
**Director, Global Clinical Affairs,** will lead the clinical study strategy, planning and execution of allergy and autoimmunity assays and instruments. The Director will sit on the Medical and Scientific Affairs (MSA) Leadership Team, reporting to the Vice President, Global Medical and Scientific Affairs.

This role will have the direct responsibility for the design, execution, oversight and analyses of studies related to allergy and autoimmunity tests and instruments within the Immunodiagnostics Division (IDD) of the Specialty Diagnostics Group. Registration study coordination will also be essential in this role.

The Clinical Director will also work closely with the IDD Research and Development organization as well as IDD Regulatory Affairs to develop the appropriate clinical studies to drive optimal clinical development of IDD products and instruments.

In addition, this individual will play a critical role in defining the clinical strategy for the division by partnering with the MSA leadership and cross-functional teams.

**What will you do?**
- Develops, executes, and reports clinical affairs planning for IDD pipeline and portfolio of tests and instruments.
- Works closely with senior management to translate business commercial objectives into a global clinical affairs strategy
- Ensures successful planning, design, and execution of clinical trials and subsequent publications while meeting regulatory requirements for clinical evaluations and post-market surveillance
- Develops budgets for all clinical trial projects
- Partners with Clinical Research Group (a division of Thermo Fisher Scientific) to identify a team of Clinical Research Associates and other team members to execute IDD studies
- Develops, maintains and expands collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs
- Develops and ensures execution of SOPs and work instructions in compliance with regulatory guidelines
- Identifies clinical training needs and develops training materials for in-house and clinical site use
- Liaisea with R&D, Regulatory, Commercial Operations and Marketing organizations to ensure clinical evidence for product and instrument pre
- and post-launch supports the strategic plan across the globe

**How will you get here?**

**Education**:

- Master’s Degree or higher required (MS, PA, MD, PhD, NP or equivalent advanced degree) however, 8+ years of clinical affairs experience and proven track record will be considered.

**Experience, knowledge, skills, abilities**:

- 8+ years of experience in a regulated industry required (e.g. medical devices, diagnostics, pharmaceuticals), experience in in-vitro diagnostics (IVD) preferred
- Proven people management skill of 7+ years with ability to bring out the best in others
- Demonstrated expert knowledge and understanding of applicable GCP, IVDR, FDA and applicable guidelines
- Strong clinical/medical background with ability to successfully communicate and teach in a complex and competitive environment
- Experience in allergy, immunology, autoimmunity or pathology is preferred
- Outstanding operational skills and experience building and optimizing global Clinical Affairs professionals
- This position requires domestic and occasional international travel - up to 50%, as required.
- Strong interpersonal, organizational and communication skills, both written and oral.
- Active membership in related key national professional associations preferred
- Previous health care experience in a corporate setting is preferred
- Strong analytical and qualitative skills are required, as well as the ability to interpret and integrate study results, draw conclusions/implications, and translate into business decision recommendations required
- Works with investigator-sponsored studies and company-sponsored studies, as well as selection of and partnership with clinical research organizations preferred
- Demonstrated ability to synthesize clinical and health economic data and influence strategy development
- Demonstrated ability to operate independently, to take initiative, be resourceful, and exercise astute clinical judgment to drive performance
- Ability to lead and influence change is required, as well as the demonstrated ability to motivate and lead diver

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