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Director - Biomarker Services
1 month ago
Biomarker Service Director
Full-time
Location: on site (Exton, PA)
Summary:
The Biomarker Service Director plays a key role in scientific initiatives, helping the operations team to establish various methods and ensure the successful delivery of projects. Additionally, the Director fosters the growth and development of the scientific staff through coaching, mentoring, and education/training. Serving as the Subject Matter Expert (SME) in biomarker, the Director is vital in all communications with external clients, contributing significantly to Frontage's Global Biomarker Service Strategies. This includes presenting Frontage's biomarker capabilities and capacity, engaging with biopharma sponsors to understand their bioanalytical needs, and supporting the Frontage business development team by reviewing proposals, RFIs, RFPs, SOWs, and final contracts.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Lead Biomarker Initiatives: Provide expertise, strategic, and scientific oversight to build and strengthen the biomarker services within the Biomarker Department.
• Support to Operations and Commercial Teams: Respond to client requests specifically needing biomarker services by participating in client meetings, calculating pricing, and providing relevant information in a timely manner.
• Day-to-Day Support: Assist clients and operations staff in developing scientifically sound and regulatory compliant solutions in the design, execution, and evaluations of studies, including addressing deviations and unexpected results.
• Present Frontage Biomarker Capabilities: Share the capabilities and capacity of Frontage’s biomarker services within the Biomarker department to prospective clients.
• Quality Assurance Audits: Participate in and prepare responses for both internal and external technical and quality assurance audits as required.
• Industry Engagement: Engage in industry technical and trade groups to elevate the company's standing as an industry leader, generate new business leads, and deepen market insights.
• Industry Trends: Maintain up-to-date knowledge of relevant scientific and technical advances and regulatory changes specific to biomarker within the Biomarker field. Provide this information to senior management for strategic planning.
• Knowledge Sharing: Identify subject matters (both technical and service-driven) for potential publication or presentation that showcase Frontage’s expertise in biomarker within the Biomarker sector.
• Strategic Planning: Support development of short-range and long-range operational objectives, organizational structure, staffing requirements, and succession plans specific to the biomarker services within the biomarker department.
• Continuous Improvement: Advocate for and support continuous improvement of processes within the Biomarker department, focusing on biomarker services.
• Perform all other duties as assigned.
MINIMUM QUALIFICATIONS:
• PhD or equivalent in biological sciences or related fields
o 10+ years of experience in the biotechnology or pharmaceutical industry. Strong background in biopharmaceutical testing involving Simoa, ELLA, MSD, and ELISA.
• Experience in a GLP environment.
• CRO experience is desired but not a must.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Must possess excellent management and communication skills and have the ability to lead a multi-disciplinary department.
• Must have solid understanding of GLP, FDA Guidance or CLIA.
• Excellent Communicator and Client-Focused.
• Regular domestic and international travel required.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
