Bioanalytical Principle Investigator-Biomarkers

Bioanalytical Principle Investigator-Biomarkers Updated: Yesterday Location: Morrisville, NC, United States Job ID: 25109687 Bioanalytical Principle Investigator-Biomarkers Job Responsibilities Plan, organize, manage and monitor their work unit’s activities according to their field of expertise, the work plan, and the needs of the organization in order to achieve the expected results. Collaborate on various critical activities such as workforce planning, hiring, provide input in performance management and daily monitoring of productivity; facilitate knowledge development and ensure the team’s efficiency and mobilization. Help to develop their work unit’s performance indicator systems and analyze established objectives. Identify opportunities for improvement. Determine, as needed, the necessary actions to be taken in order to streamline efficiency. Monitor and manage budgets of assigned projects and ensure adherence and complete revenue recognition. Perform budget follow‑up for pertinent stakeholders and recommend actions in an effort to achieve the expected results. Communicate the necessary information to ensure colleagues and the organization are aware of their team’s work plan, policies, projects, processes, results, and actions. Collaboration with partners in the Training team to ensure training is available for team members. Represent their work units, both internally and externally, as to consultation and/or information and/or reference. Advise internal/external clients of their division’s particular areas of expertise by assessing needs, and carrying out analysis and follow‑ups. Participate in regulatory agency inspections and client audits as well as the ensuing response process. Project manager role: Primary client liaison and point of contact for assigned sponsor projects. Receive and distribute information as appropriate from each of these sponsors. Keep the sponsors fully informed of timelines, project milestones and ensure timely communication on bioanalytical studies. Support business development activities to grow and maintain new and existing clients. Serve as the Principal Investigator for pre‑clinical and bioanalytical studies. Prepare, revise and/or approve all documentation related to the assigned projects. Partner with Business Development and the Cost Proposal team to prepare various quotes related to service requests made by clients. Responsible for the technical and regulatory requirements of the bioanalytical study. At times, may direct and participate in the development of new bioanalytical methods. Provide technical expertise to the laboratory staff. Administrative responsibilities including a detailed, accurate short‑term forecast of revenue (3 months) and a less detailed long‑term forecast (6‑9 months). Daily interaction with the scientific team and management to establish priorities of assignments. Result analysis/reporting manager role: Review audit reports and observations in order to maintain a high level of quality and consistency. Ensure monitoring of corrective actions and preventive actions (CAPA). Ensure the smooth functioning and quality of result analysis. Involve in problem solving and decision‑making. Involve in bioanalytical report writing and prioritization. Ensure compliance and evaluate, identify and communicate the regulatory risks to senior management. Participate in the harmonization of work methods between the different divisions/services as well as the different sites. Participate in drafting/revising SOPs. Optimize and ensure the implementation of their teams working procedures and techniques in order to improve quality. Direct and guide archive management within the division. Review data and results ahead of client / internal delivery to ensure data is in line with quality expectations. Qualifications Experience in the management of technical and scientific staff. Demonstrated leadership, line management, tactical and strategic thinking skills. Extensive knowledge of GLP/EMA guidelines and other applicable regulatory requirements. Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel. Excellent communications, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade. Experience within a client‑service environment, either in a contract laboratory or within a core group at a pharmaceutical company. Demonstrate scientific problem solving skills. Benefits Company car or car allowance. Health benefits to include medical, dental and vision. Company matching 401(k) contributions. Eligibility to participate in Employee Stock Purchase Plan. Eligibility to earn commissions/bonuses based on company and individual performance. Flexible paid time off (PTO) and sick time. Salary Salary Range: $79,800.00 - $139,600.00 Summary 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. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #J-18808-Ljbffr