Bioanalytical Principle Investigator-Biomarkers

Bioanalytical Principle Investigator-Biomarkers Updated: Yesterday Location: Princeton, NJ, United States Job ID: 25109687-OTHLOC-1131 This role is responsible for overseeing biomarker projects from initiation through execution, supporting bid defense activities, and partnering with business development to develop competitive and accurate quotes for new programs. Job Responsibilities Plan, organize, manage and monitor work unit activities according to field of expertise, the work plan, and organizational needs to achieve expected results. Collaborate on critical activities such as workforce planning, hiring, performance management, daily monitoring of productivity, and knowledge development to ensure team efficiency and mobilization. Help develop performance indicator systems, analyze objectives, identify improvement opportunities, and determine necessary actions to streamline efficiency. Monitor and manage budgets of assigned projects, ensure adherence and complete revenue recognition, perform budget follow‑up for stakeholders, and recommend actions to achieve expected results. Communicate necessary information to ensure colleagues and organization are aware of the team’s work plan, policies, projects, processes, results, and actions. Collaborate with partners in the Training team to ensure training availability for team members. Represent the work unit internally and externally for consultation, information, or reference. Advise internal/external clients of the division’s expertise by assessing needs, conducting analysis, and following up. Participate in regulatory agency inspections and client audits as well as the ensuing response process. Serve as the Principal Investigator for pre‑clinical and bioanalytical studies and prepare, revise, or approve all related documentation. Partner with Business Development and the Cost Proposal team to prepare quotes for service requests made by clients. Provide technical expertise to laboratory staff and direct participation in development of new bioanalytical methods. Handle administrative responsibilities including short‑term revenue forecasting (3 months) and longer‑term forecast (6‑9 months) and interact daily with scientific team and management to set priorities. Review audit reports and observations to maintain high quality and consistency. Ensure monitoring of CAPA (corrective and preventive actions) and smooth functioning of result analysis. Participate in problem solving and decision‑making, bioanalytical report writing, and prioritization. Ensure compliance and assess regulatory risks to senior management. Participate in harmonization of work methods between divisions/services and sites. Draft or revise SOPs and optimize implementation of team procedures and techniques to improve quality. Direct and guide archive management within the division. Review data and results before client/internal delivery to ensure alignment with quality expectations. Additional Qualifications Experience managing technical and scientific staff. Demonstrated leadership, line management, tactical and strategic thinking skills. Extensive knowledge of GLP/EMA guidelines and other regulatory requirements. Proficiency with Microsoft Word and Excel. Excellent communication, presentation, interpersonal skills, written and spoken. Experience in a client‑service environment, either in a contract laboratory or core group at a pharmaceutical company. Demonstrated scientific problem‑solving skills. Benefits We reward and recognize our people by providing valuable benefits and a quality‑of‑life balance. The benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), company match 401(k), eligibility to participate in an Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Payable sick time eligibility may vary by location. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $79,800.00 - $139,600.00 Actual salary will vary based on qualifications, skills, competencies, and proficiency for the role. Equal Opportunity Statement This Company is committed to compliance with the Americans with Disabilities Act and shall provide reasonable accommodations to employees or applicants to assist performance of essential job functions. All qualifications and responsibilities may be modified by the Company at its discretion, and the Company may assign additional duties as necessary. #J-18808-Ljbffr