What are the responsibilities and job description for the Director - Biomarker Services (Exton, PA) position at CEDENT?
Biomarker Service Director
Location : Exton, PA/ On-site
Full-time
Lead Biomarker Initiatives: Provide expertise, strategic, and scientific oversight to build and strengthen the biomarker services within the Biomarker Department.
Location : Exton, PA/ On-site
Full-time
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 Client Biomarker Capabilities: Share the capabilities and capacity of Client’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 Client’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.
- PhD or equivalent in biological sciences or related fields
- 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.
