Job Summary

The Clinical Scientific Manager (CSM) fulfills two key functions within the Strategic Business Unit (SBU) for Autoimmunity in San Diego. The CSM plays are key role as Autoimmunity’s scientific subject matter expert by representing the company at a 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 of our assays and developing content to promote their value to our customers. In addition, 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.

Key Accountabilities

• Scientific Education Strategy: Develop and execute comprehensive scientific education strategies and programs. Collaborate within the SBU Marketing team to align the education initiatives with business objectives. The CSM will develop a customer focused educational campaign focused on existing Werfen products or products in development, to be executed with commercial teams. The CSM will also create content for the internal Werfen Autoimmunity teams to ensure that they understand basic concepts and stay up to date regarding new scientific developments.
• 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. The CSM will create clinical material to support customer facing applications and commercial teams to enhance their understanding of autoimmunity in order to effectively support customers.
• 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. The CSM will work with key opinion leaders and topic specific experts to create content for presentations. The CSM will also directly present topics related to autoimmunity in these forums.
• Key Opinion Leader (KOL) 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. The CSM will communicate with KOLs to engage with Werfen as scientific advisors to educate Werfen Marketing and R&D on topics related to product development and to share their vision for the future. This communication can take the form of regular communication with KOLs or organized meetings with several KOLs for this purpose.
• Clinical On-market Escalated Support: support escalated investigations for key Werfen stakeholders (affiliates and customers, when applicable) in managing inconclusive or seemingly unsupported clinical scientific outcomes, including from external quality programs. The CSM will review escalated complaints with a cross-functional team on a regular basis, direct internal investigations and communicate status and outcomes (written or live) with global affilates and customers
• 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. The CSM will often participate in direct discussions or meetings with laboratorians and clinicians to provide expertise and guidance related to clinical or product focused topics.
• 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. CSM may work directly with patient advocasy 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, both among the Technology Center and affiliates. CSM will regulary review evolving international guidelines for diagnosis and treatment of autoimmune diseases and become involved in guidleine 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.

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

Networking/Key relationships

This 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, Immunoas-says, 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.
• 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.

Skills & Capabilities:

• Knowledge of immunology and immunoassay technology, particularly with Autoimmune diagnos-tics 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, interper-sonal skills, project management skills and self-motivation.
• Proven track record independently producing quality and timely work in a fast-paced environ-ment 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.

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.  Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.  May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.  Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  May occasionally have to lift and/or move up to 25 pounds.  The noise level in the work environment will vary but is usually moderate. 

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 $150,000 - $210,000. 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.