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Werfen North America · 4 days ago

Clinical Scientific Manager

San Diego, CA

Full-time

Onsite

Senior Level

$150K/yr - $210K/yr

5+ years exp

Werfen North America is a global company specializing in medical diagnostics, and they are seeking a Clinical Scientific Manager to fulfill key functions within the Autoimmunity Strategic Business Unit. The role involves being a scientific subject matter expert, developing educational strategies, creating clinical materials, and engaging with key opinion leaders to enhance product understanding and support customer satisfaction.

Health CareManufacturing

Responsibilities

Develop and execute comprehensive scientific education strategies and programs

Collaborate within the SBU Marketing team to align the education initiatives with business objectives

Develop a customer focused educational campaign focused on existing Werfen products or products in development, to be executed with commercial teams

Create content for the internal Werfen Autoimmunity teams to ensure that they understand basic concepts and stay up to date regarding new scientific developments

Ensure effective and engaging clinical materials, presentations, and resources for Werfen employees and external stakeholders to enhance understanding of Autoimmunity solutions and their clinical applications

Create clinical material to support customer facing applications and commercial teams to enhance their understanding of autoimmunity in order to effectively support customers

Support scientific workshops, webinars, seminars, and symposia for healthcare professionals, researchers, and key opinion leaders to promote awareness and knowledge of Autoimmunity solutions

Work with key opinion leaders and topic specific experts to create content for presentations

Directly present topics related to autoimmunity in these forums

Build and maintain relationships with key opinion leaders and renowned scientists

Collaborate on research initiatives and seek insights to enhance product development and education strategies

Communicate with KOLs to engage with Werfen as scientific advisors to educate Werfen Marketing and R&D on topics related to product development

Support escalated investigations for key Werfen stakeholders in managing inconclusive or seemingly unsupported clinical scientific outcomes

Review escalated complaints with a cross-functional team on a regular basis, direct internal investigations and communicate status and outcomes with global affiliates and customers

Assist Marketing and Affiliate teams in clinical discussions and presentations with potential clients, healthcare professionals, and laboratory personnel

Provide scientific expertise and address queries to facilitate successful commercial efforts

Stay abreast of the latest advancements and research developments, including from competition

Analyze clinical and scientific trends to ensure the company remains at the forefront of scientific innovation

Increase clinical awareness of Autoimmunity diseases and the importance of accurate and timely patient diagnosis

Work directly with patient advocacy groups as well as specific clinical autoimmunity initiatives globally

Evaluate, at an international level, the clinical guidelines related to our products and solutions and help to spread them throughout the company

Regularly review evolving international guidelines for diagnosis and treatment of autoimmune diseases and become involved in guideline committees when possible

Comply with applicable standard operating procedures (SOPs), ISO, FDA and other applicable Quality System regulations, as well as with applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies

Demonstrate company values in quality of work and working relationships

Qualification

Immunology knowledgeImmunoassay technologyClinical lab environmentRegulatory compliance knowledgeScientific education strategiesCustomer facing interactionsCross-functional team leadershipFluency in EnglishPresentation skillsCommunication skillsEmotional intelligenceProject management skills

Required

Master's Degree, or equivalent, in a relevant scientific discipline (e.g. Immunology, Immunoassays, Rheumatology) required, PhD preferred

Previous experience of at least 5 years in Marketing Department/Clinical Affairs in a multinational company required, preferably in the IVD or Medical Device industry

Advanced experience and demonstrated business acumen, agility, and confidence in making decisions required

Alternatively, at least 5 years of experience as an Immunology Supervisor (or higher) in a large healthcare system

Advanced experience and demonstrated indirect leadership of cross-functional teams within organizations required

Successful track record of customer facing interactions with a strong technical background in ELISA, IFA, CIA, and PMAT

Comfortable presence with senior leadership and customer technical contacts

Knowledge of immunology and immunoassay technology, particularly with Autoimmune diagnostics methodologies

Knowledge of the clinical lab environment, ideally with in vitro diagnostics

Strong background in scientific education, training, and communication strategies

Knowledge of relevant regulations and compliance standards governing the IVD industry (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, ISO 17025, IEC 60825 or other regulations and standards)

Exceptional presentation, communication, and emotional intelligence skills, with the ability to convey complex scientific concepts to diverse audiences

Ability to adapt to an evolving business and industry, leveraging previous knowledge, interpersonal skills, project management skills and self-motivation

Proven track record independently producing quality and timely work in a fast-paced environment with demonstrated agility, resilience, and initiative

Comfortable working in under multiple deadlines and priorities

Fluency in English, both written, spoken and reading