Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Job Summary

The Clinical Scientific Manager (CSM) fulfills two key functions within the Worldwide Marketing department for Autoimmunity. As a clinical expert in Autoimmunity, the CSM is responsible for coordinating internal resources to drive resolution to complex customer product investigations, resolve technical issues not related to complaints to achieve Affiliate and customer satisfaction, and interfacing within and outside Werfen, including responsibility for effective technical communications, reporting, and presentations. The CSM plays a key role as Autoimmunity's medical/scientific subject matter expert by representing the company at the worldwide level and assisting in identifying, developing and maintaining relationships with international key medical experts and opinion leaders, as well as support of scientific studies. This position plays a crucial role in promoting scientific understanding and ensuring product knowledge.

Key Accountabilities* Clinical On-market Escalated Support: support escalated investigations, Autoimmunity departments (ex: Product Complaints Group, R&D, Marketing, Manufacturing, Quality, among others), Werfen stakeholders (affiliates and customers, when applicable) in managing inconclusive or seemingly unsupported clinical scientific outcomes, including from external quality programs.* Scientific Guidance: apply scientific principles and techniques to tasks and experiments; direct cross-functional technical groups on data collection, experiment design, and the use of root cause analysis quality tools, organization, and interpretation of data to draw conclusions, develop recommendations for corrections, corrective and preventative actions and ensure documentation of the issue investigation and resulting actions.* Scientific Education Strategy: Develop and execute comprehensive scientific education strategies and programs. Collaborate with the Marketing team to align the education initiatives with business objectives.* Material Creation: 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.* External Workshops and Seminars: Support scientific workshops, webinars, seminars, and symposia for healthcare professionals, researchers, and key opinion leaders to promote awareness and knowledge of Autoimmunity solutions.* Key Opinion Leader Networking & Engagement: 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.* Commercial Partnership: 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.* Clinical Market Intelligence: 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.* Evaluate at an international level the clinical guidelines related to our products and solutions and help to spread them throughout the company, both among the Technology Center and affiliates.* 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.* Demonstrates company values in quality of work and working relationships.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions

Networking/Key relationshipsThis position requires extensive collaboration and partnership with teams:

* Marketing & Global Systems Support* Product Complaints Group* R&D teams, including Manufacturing Technical Support (MTS)* Regulatory Affairs* Manufacturing, Operations & Logistics* Global Affiliates & Distributors* Quality Teams (Quality Assurance, Quality Engineering, Quality Product Support, Post Market Compliance, Document Control)

Minimum Knowledge & Experience required for the position

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

Qualifications * 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.* 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 executive leadership and customer technical contacts.

Skills & Capabilities:* 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.Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Travel requirements:Up to 30%, may include international travel and/or travel on short notice

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position.

Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The salary range for this position is currently $120,000- $180,000 annual. Individual compensation is based on the candidate's qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com