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Werfen · 3 months ago

Clinical Scientific Manager

US-CA-San Diego

Full-time

Onsite

Senior Level

$150K/yr - $210K/yr

5+ years exp

Werfen is a global company operating in the healthcare sector, particularly in Autoimmunity solutions. The Clinical Scientific Manager (CSM) is responsible for developing scientific education strategies, creating clinical materials, and building relationships with key opinion leaders while supporting commercial efforts and ensuring customer satisfaction.

Health CareHospitalManufacturingMedical Device

Responsibilities

Develop and execute comprehensive scientific education strategies and programs

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

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

Build and maintain relationships with key opinion leaders and renowned scientists

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

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

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

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

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

Comply with applicable standard operating procedures (SOPs), ISO, FDA and other applicable Quality System regulations

Qualification

Immunology knowledgeImmunoassay technologyClinical lab environmentScientific education strategiesRegulatory compliance knowledgeCustomer engagementPresentation skillsFluency in EnglishEmotional intelligenceProject management

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