Associate Clinical Scientific Manager

Werfen is a growing family-owned innovative company founded in 1966 in Barcelona Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis Acute Care Diagnostics Transfusion Autoimmunity and Transplant. Through our Original Equipment Manufacturing (OEM) business line we research develop and manufacture customized assays and biomaterials. We operate directly in 30 countries and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe and our workforce is more than 7000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas our commitment to customers and our dedication to innovation and quality. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The Associate Clinical Scientific Manager (ACSM) fulfills two key functions within the Strategic Business Unit (SBU) for Autoimmunity in San Diego. This position plays a crucial role in promoting scientific understanding of our assays and developing content to promote their value to our addition the ACSM 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 addition the ACSM will play a key role in supporting scientific studies.

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 ACSM will develop a customer focused educational campaign focused on existing Werfen products or products in development to be executed with commercial teams. The ACSM 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 ACSM will create clinical material to support customer-facing applications and commercial teams to enhance their understanding of autoimmunity in order to effectively support customers.
• 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 ACSM 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 ACSM 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 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. ACSM may 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 both among the Technology Center and affiliates. ACSM will 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.

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

• Masters 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.
• 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 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 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 annual base salary range for this role is currently $109952 range to $164388 range. Individual employee compensation will ultimately depend on factors including education relevant experience skillset knowledge and particular business needs.

This role is eligible for medical dental and vision insurance 401k plan retirement benefits with an employer match as well as paid vacation and sick sales roles are eligible for participation in a commission plan and our managementand select professional rolesare eligible for a performance-based bonus.

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

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.

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

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.