Associate Director and Technical Manager, Clinical and Targeted Analysis
JOB CODE 1188
Raleigh-DURHAM, NC, USA
Metabolon, Inc., is the global leader in revealing new biological insights through metabolomics, harnessing the power of its Precision Metabolomics™ Platform to provide biological insights of disease state and physiological reactions in the present time. The company offers scalable, customizable metabolomics solutions from discovery through clinical trials and product life-cycle management. Leveraging one of the world’s most diverse and rich patient data sets, Metabolon is equipped to deliver biologically relevant insights to address some of the most difficult and pressing questions in the life sciences, helping to accelerate research and product development success in the biopharma, population health, consumer products, wellness and academic research sectors.
Metabolon, headquartered in Research Triangle Park, NC, is a diagnostic products and services company offering the industry’s leading biochemical profiling platform. The Associate Director and Technical Manager, Clinical and Targeted Analysis (CTA) is responsible for developing and maintaining relationships with pharmaceutical clients and leading a team of scientists in the development of targeted biomarker assays. Reporting to the Vice President, Clinical and Targeted Analysis, the Associate Director will be responsible for:
- Responsible for relationship management to our pharmaceutical clients in support of drug development, preclinical and clinical studies by:
- Supporting the business development process, in collaboration with our sales and business development teams, from the identification of initial opportunities, through the development of specific proposals, to delivery of a signed contract, utilizing appropriate internal resources.
- Developing, maintaining, and extending relationships with existing customers to ensure repeat business, and additional account growth.
- Providing consultation with prospective and current customers regarding method development and study design.
- Working with the sales and business development teams to Identify, pursue, and develop relationships with new and potential customers
- Providing guidance to Metabolon sales and marketing staff to ensure proper messaging to clients regarding available CTA services. Promoting CTA services to sales personnel at national sales meetings and during one-on-one conversations.
- Participating in the development of marketing and sales plans by providing marketing intelligence and input as required. Assisting in the implementation of sales and marketing strategies and tactics.
- Representing the organization at professional meetings, trade shows, and conferences as needed to maintain visibility and market awareness.
- Coordinating with Discovery and Translational Sciences leaders within Metabolon to identify pharmaceutical clients who may benefit from targeted biomarker assay development and then participate in client meetings with the intent to transition the client from discovery to biomarker development.
- Providing leadership and resource management for the development of targeted LC-MS/MS assays by:
- Ensuring all duties and responsibilities, either performed or delegated, are properly executed and compliant with company quality management plan and applicable regulatory guidelines.
- Hiring, managing,training and allocating staff responsible for developing and validating all targeted LC-MS/MS assays.
- With assistance from the Senior Group Leader and Senior Scientists, and relying on his/her own expertise, make decisions regarding method development, including study design and trouble shooting exercises, with the end goal of producing the highest quality targeted LC-MS/MS assays.
- Ensure that resources for method development (MD) in the CTA group are appropriately designated by:
- Hiring, managing, training and allocating MD staff responsible for commercial and clinical targeted assays development.
- Ensuring that properly maintained and qualified instrumentation is available for use in MD projects.
- Work with appropriate individuals and departments to eliminate wasteful processes and improve MD project workflows.
- Participate in all stages of the sales process from early client discussions to assistance in preparation of quotes
- As a Clinical Research Organization (CRO), ensure that the departmental processes, services and deliverables meet pharmaceutical client expectations. Where CRO business practice gaps exists, work to remediate any deficiencies.
- During method development exercises, ensure that personnel are following the appropriate regulatory standard in compliance with company-wide quality management plans.
- Responsible for the selection of all laboratory equipment, supplies, and services with respect to method development. Hire MD laboratory personnel and ensure that enough appropriately educated, experienced, and/or trained personnel are available to carryout method development and validation studies to meet the needs and commitments of the department.
- Provide technical guidance and strategy for method development and method validation.
- Prepare method validation documents or delegate such duties.
- Perform and lead project feasibility assessments
- Provide opportunities for MD staff to receive continuing education relevant to the practice of bioanalytical method development
- Assess competency, and whenever necessary, provide remedial training or continuing education to improve skills of MD personnel
- Assist in troubleshooting technical laboratory issues, review and approve all procedures and, if absent, ensure that qualified personnel have been delegated to provide technical oversight to MD personnel and instruments
- Ensure MD and validation reports include pertinent information for method performance characterization, interpretation and be available for consultation concerning rendered services. Monitor all work performed in the laboratory to ensure that scientifically reliable data are generated. Maintain oversight of physical and electronic filing systems for MD data and ensure documentation gets filed appropriately
- Ensure that physical and environmental conditions of the laboratory are adequate and appropriate for method development and validation
- Ensure that the environment for employees and the public is safe from physical, chemical, and biological hazards and safety and biohazard requirements are followed.
- Participate and actively manage Quality Assurance duties. Provide oversight of all aspects of the laboratory’s quality management system to ensure conformance to requirements described in the Quality Management System.
- Support and promote opportunity and avenues for personnel to be involved in the assessment and management of the Quality Management System and to contribute to continuous improvement of the Quality System. Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the method development and validation process.
- Ensure that all appropriate remedial actions are taken and documented whenever significant deviations from the laboratory’s established procedures are identified, and that method development and validation exercises are completed only when the system is functioning properly
- Provide effective and efficient administrative direction of the laboratory, including budget planning and appropriate cost controls in conjunction with the individuals responsible for financial management of the laboratory.
- Participate in efforts to develop more efficient workflow processes through the identification, installation and validation of LIMS systems or changes to existing validated systems
- PhD/MS in chemistry, biochemistry or related field and at least 10 years of relevant experience.
- Experience with method development and validation in a bioanalytical setting with mass spec technology.
- Experience working in a Clinical Research Organization supporting preclinical and clinical biomarker development for pharmaceutical clientele.
- Experience in developing relationships with existing and prospective clients with the goal of developing business opportunities.
- Demonstrates highly developed verbal and written communication skills.
- Demonstrated track record of good decision-making, leadership, and organizational skills.
- This is a full-time position requiring approximately 40 hours per week of onsite work.
Metabolon, Inc., is the global leader in revealing biological insights on disease state and physiological reactions in the present time through metabolomics. Leveraging one of the world’s most diverse and rich patient data sets, Metabolon is equipped to deliver biologically relevant evidence to address some of the most difficult and pressing questions in the life sciences. Every day, our work is helping to accelerate research and product development success in the biopharma, population health, consumer products, agriculture, wellness and academic research sectors.
Metabolon was founded in 2000 and is based in Research Triangle Park, North Carolina with an international headquarters in Germany. For more information, please visit www.metabolon.com.
Metabolon is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State, or local laws. All employment decisions are based on valid job‐related requirements.