Director, Research and Development

Overview

Research and Development Directors in Werfen’s Autoimmunity business line have overall responsibility for running R&D operations.  In conjunction with the Sr. Vice President and other R&D Directors, provides strategic leadership and operational guidance to drive innovation in new product development in assigned area(s), and/or modifications to existing products.  In collaboration with the Sr. Vice President and other R&D Directors, provides direction to the R&D team.  Responsible for the development and performance of the R&D management team and their direct reports.  Ensures activities are carried out in accordance with established policies, procedures, and all applicable FDA, ISO and other regulations.  Serves as a leader on the Autoimmunity Management team.

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Responsibilities

Key Accountabilities

• Responsible for research & development operations to identify and develop best in class products, for autoimmune diseases and related conditions, that meet quality requirements, customer demand and profitability goals. Includes all activities related to identification of new biomarkers and development of products within assigned area(s).
• In conjunction with the V.P, Research & Development, develops strategic plans to achieve company objectives within assigned area(s). Ensures R&D management team has a clear understanding of strategic goals.
• Ensures operational plans are developed and executed to achieve department and organizational goals.
• Ensures all work is performed within Quality Systems requirements and processes.
• Recruits, develops and holds accountable both people managers and individual contributor direct reports.
• Ensures department managers manage operations in lines with Werfen Values, Werfen Role of the Manager expectations and competencies, and in compliance with company policies and employment regulations and laws.
• Provides leadership and guidance to management staff in assigned area(s) to develop, implement and monitor plans to achieve goals.
• Ensures successful collaboration with external organizations (FDA, KOLs, Customers, etc.) and other Werfen entities (other business lines and corporate departments, etc.).
• Fosters close collaboration with Quality and Regulatory, to ensure strict compliance with regulations to ensure activities are carried out to meet or exceed quality standards.
• Fosters close collaboration with Environmental Health & Safety (EH&S) to ensure environmental and safety regulations are met and employee and product safety is maximized.
• Fosters close collaboration with other administrative departments to ensure compliance to company policies and other regulations. Includes, but not limited to Finance, Human Resources and Operations.
• Participates in the R&D budget process; prepares and manages department and project budgets, including staffing, equipment, facilities and other capital and expense planning.
• Maintains knowledge of academic and commercial technology trends and competitive developments as input into strategic plans; acts as a key scientific resource to other Autoimmunity departments.
• Grows and fosters talent. Develops the technical and leadership capabilities of the R&D Team.  May include providing training and guidance related to product development.
• Leads a high performing team of managers and staff to achieve goals and a support a team environment, focused on continuous improvement, innovation, quality, effective management of resources and strong performance management.
• Creates a culture of compliance with applicable standard operating procedures (SOPs), ISO, FDA and other Quality Systems regulations (QSRs), as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.
• Represents the Autoimmunity Management team and reflects the company’s values as a role model to employees and customers.

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

Networking/Key relationships

• R&D Teams
• Manufacturing Teams
• Marketing Teams
• Quality Systems & Regulatory Affairs

Qualifications

Minimum Knowledge & Experience

Education:

•  Bachelor’s degree in scientific field required.

E

Experience:

• 10+ years of experience working in medical device industry required.
• 4+ years of conducting investigations strongly preferred.
• Experience working in the field of immunology diagnostic research and/or medical device development preferred.

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

Skills & Capabilities

• Deep understanding of design controls, quality system regulations and relevant regulatory requirements for the design, development and commercialization of diagnostic technologies and products.
• Experience developing budget proposals and managing to multiple budgets.
• Ability to analyze and interpret scientific data, technical journals, financial reports, government regulations and legal documents required.
• Strong financial acumen and aptitude (P&L, ROI, NPV, etc.) required.
• Demonstrated experience and a track record of success in leading high performing teams required.

Travel requirements

10-20%, including international.