Job Description

Job Summary Rules-Based Medicine (RBM), a Q2 Solutions Company, is searching for a Senior Director, Science Development. This position is responsible for leading, directing and designing scientific projects that are critical to corporate strategy and direction. Investigate the feasibility of applying a variety of scientific principles, concepts, and technologies to projects and services; and to successfully execute pharmaceutical development projects. Essential Functions

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  Leads the overall operations of the science development function. Ensures that laboratory operations meet or exceed all applicable regulatory requirements.
• Maintains scientific awareness of overall developments in the field of drug development based on current literature, application of new technologies, attendance at professional meetings, etc.
• Makes significant contributions to scientific literature, documentation and conferences including the preparation of peer-reviewed manuscripts, abstracts or patent applications including the writing and/or creation of abstracts, peer-reviewed journal articles, poster presentations, and marketing materials
• Leads the development of patent applications, vendor agreements and collaborative partnerships
• Oversees the management and professional development of the team
• Serves as in-house and outside consultant
• Leads interdepartmental activities and initiative efforts
• Oversees the maintenance and operational standards of laboratory equipment. Significantly involved in the evaluation and validation of new laboratory instruments including IQ/OQ/PQ documentation.
• Development of new and existing experimental techniques including the design and execution of validation protocols and reports, as necessary
• Leads the execution of scientific experiments and methods relying only on high-level direction including devising short and long-term project goals and trouble-shooting strategies
• Represents the organization as prime technical contact on contracts or projects requiring coordination across organizational lines
• Ensures quality and timely delivery of pre-clinical discovery deliverables to clients
• Provides scientific guidance, training and mentorship to lower level and new staff
• Ensures that the highest standards of quality and customer service are maintained. Collaborates with Quality Assurance staff on development and implementation of effective programs. Monitors outside proficiency testing program as required
• Takes corrective action promptly when results are unsatisfactory. Establishes effective staff selection and training programs to ensure that qualified staff are hired and continuously trained in order to remain current on testing procedures.
• Leads the development and implementation of the department\'s operating budget. Establish standards for cost control and waste reduction. Monitor utilization patterns of services and advise on developing trends in clinical service needs.
• Fosters a unified culture and facilitate collaboration, cooperation, sharing of information and teamwork. Lead initiatives to improve employee engagement to positively impact operational results and customer satisfaction and employee retention.
• Manages staff in accordance with organization\xe2\x80\x99s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues, and resolving problems. Approve actions on human resources matters.

Required Knowledge, Skills, and Abilities High level scientific sales support:

• PhD, 5+ yrs of immunoassay biomarker experience
• Strong technical understanding of RBM immunoassay capabilities, platforms, validation, assay development
• Ability to be a scientific speaker and leader for high level capabilities presentations to customers or conference presentations
• Ability to summarize relevant immunoassay biomarker findings (publications) into technical presentations
• Understand broad category of drug MOAs and relation to pharmacodynamic goals of customers
• Problem solving and relationship building

RBM scientific/technical Leadership:

• PhD, 5+ yrs of immunoassay biomarker experience
• Provide scientific guidance and support to RBM general manager, lab director, and other department heads
• Ability to appropriately adjust communication as needed; highly technical or simplified.

Scientific oversight and management of TruCulture product development & applications with key vendor (HOTScreen Gmbh):

• PhD, 5+ yrs of Immunology & cell-based assay experience
• Aptitude to develop a business and scientific relationship with key HOTScreen management (Manfred Schmoltz, Gerburg Stein, Thomas Knorpp)
• Manage and understand new applications, bridging commercial opportunities with HOTScreen capabilities, agenda, and capacity (e.g. vaccine antigen recall applications)
• Guide Austin TruCulture personnel on process and development priorities

Assay development strategy, commercial implementation & contracting:

• PhD, 5+ yrs of immunoassay development experience
• Extensive knowledge of clinical trial pharmacodynamic soluble immunoassay biomarker marketplace (keep abreast of new and up and coming soluble protein biomarker assays.)
• Ability to write technical aspects of quotes/WOs for customer driven assay dev projects.
• Aid BD team in assay development project meetings with customer and RBM assay dev team, bridging managing customer expectations with RB
• Capabilities in product management for overseeing assay dev group in selecting new assays to develop.
• Approve the use of commercial ELISAs to bring in-house for select strategic opportunities
• Ability to lead scientific relationship with BMS for the IPF (Idiopathic Pulmonary Fibrosis) biomarker project.
• Understanding of the loose regulatory environment/oversight for pharmacodynamic, exploratory biomarkers used for clinical and translational research studies. Familiarity with FDA biomarker guidance documents and context of use (COU).

Scientific/technical marketing content generation:

• PhD, 5+ yrs of biomarker experience
• Understanding of technical marketing
• Ability to synthesize publications citing RBM biomarker results testing into short technical marketing collateral.
• Author whitepapers, Tech Notes and & Application Notes on particular biomarkers, applications and new platforms (e.g. Olink)

Q\xc2\xb2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe As the COVID-19 virus continues to evolve, Q\xc2\xb2 Solutions\' ability to operate and provide certain services to customers and partners necessitates Q\xc2\xb2 Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status