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Head of Biomarker Services
2 months ago
Position: Biomarker Services Director
Employment Type: Full-time
Location: On-site
Role Summary:
The Biomarker Services Director is instrumental in advancing scientific projects, collaborating with operational teams to implement diverse methodologies and ensure project success. This role also emphasizes the professional growth of scientific personnel through mentorship, coaching, and training initiatives. As the Subject Matter Expert (SME) in biomarkers, the Director is crucial in liaising with external clients, significantly impacting Frontage's Global Biomarker Service Strategies. Responsibilities include showcasing Frontage's biomarker capabilities, engaging with biopharma sponsors to assess their bioanalytical requirements, and aiding the business development team in reviewing proposals, RFIs, RFPs, SOWs, and contracts.
KEY RESPONSIBILITIES:
- Lead Biomarker Initiatives: Provide strategic guidance and scientific oversight to enhance biomarker services within the department.
- Client and Operations Support: Address client inquiries regarding biomarker services by participating in meetings, calculating pricing, and delivering pertinent information promptly.
- Daily Operations Assistance: Aid clients and operational staff in crafting scientifically sound and regulatory-compliant solutions for study design, execution, and evaluation, including managing deviations and unexpected outcomes.
- Showcase Frontage's Capabilities: Present the biomarker service offerings to potential clients, highlighting the department's strengths.
- Quality Assurance Participation: Engage in and prepare for internal and external technical and quality assurance audits as necessary.
- Industry Engagement: Participate in technical and trade groups to enhance the company's reputation as an industry leader, generate new business opportunities, and deepen market insights.
- Stay Informed on Industry Trends: Maintain current knowledge of scientific advancements and regulatory changes in the biomarker field, providing insights for strategic planning.
- Knowledge Dissemination: Identify topics for potential publication or presentation that demonstrate Frontage's expertise in biomarkers.
- Strategic Development: Assist in formulating short-term and long-term operational goals, organizational structure, staffing needs, and succession planning for biomarker services.
- Continuous Improvement Advocacy: Promote and support ongoing enhancements to processes within the Biomarker department.
- Additional Duties: Perform other responsibilities as assigned.
MINIMUM QUALIFICATIONS:
- PhD or equivalent in biological sciences or related disciplines.
- 10+ years of experience in the biotechnology or pharmaceutical sector, with a strong background in biopharmaceutical testing methods such as Simoa, ELLA, MSD, and ELISA.
- Experience in a GLP environment is preferred.
- CRO experience is advantageous but not mandatory.
- An equivalent combination of education and experience may be considered.
- Exceptional management and communication skills, with the ability to lead a multidisciplinary team.
- Thorough understanding of GLP, FDA Guidance, or CLIA regulations.
- Strong communication skills and a client-focused approach.
- Willingness to travel domestically and internationally as 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.
