Biomarkers and Genomic Medicine Senior Scientific Director

The Senior Scientific Director will be part of our global Translational Medicine team within Parexel clinical development organization. This role is an established and recognized expert and thought leader in the field of Bioanalytical, Biomarkers, and Companion Diagnostics, with extensive experience in defining and executing biomarker, companion diagnostic, and other devices development strategy.

This role will provide scientific consulting and support sales in biomarker, companion diagnostic development, and precision medicine related specialties. He/she will initiate and maintain scientific and consultative relationships with clients influencing biomarker, companion diagnostic, and translational medicine strategy of client programs. The Senior Scientific Director will provide strategic leadership, drives continuous improvements in meeting client expectations, and influences cross-functional teams and broader organization to ensures Translational Medicine team continues to deliver state-of-the-art capability and integrated solutions.

Key Accountabilities: Leadership responsibility for technical and regulatory strategy to support the development of biomarkers and companion diagnostic tests. Provide technical and regulatory input on key development documents, including but not limited to assay plan/reporting/review, clinical protocol, IBs, INDs, CTAs, IDEs, SRD, PMAs, , in collaboration with matrix functions (e.g. clinical and regulatory teams) Leads or contributes to execution planning and oversight for bioanalytical, biomarker, companion diagnostic development and translational medicine studies. Accountable for operational delivery of client programs and projects to timelines, quality expectations and regulatory requirements. Consults internally and externally on biomarker, genomics, precision/personalized medicine strategies, capabilities, regulatory requirements, companion diagnostics development, partnerships, and due diligence experience. Provides scientific and technical leadership to support Business Development, Business Operations and Marketing activities. Review and lead preparation of Request for Information (RFI) and Request for Proposal (RFP) for potential clients. Authors or contributes to the development and review of clinical protocols, clinical study reports, regulatory responses and submissions and publications for peer review journals. Represents Parexel at scientific and marketing meetings, work with Marketing in the preparation and participation of webinars, symposiums, industry conferences, and white papers. Delivers sales and marketing presentations to prospective clients and negotiates work agreements. Manages the project to contract, including proactive management of budget, pass-through costs and contract amendments where necessary. Develops and maintains a positive relationship with internal and external clients and team members, building partnerships and promoting teamwork. QualificationsJob Qualifications: PhD degree level (genetics, molecular biology, pharmacology or related life science discipline) Fifteen or more years’ experience in pharmaceutical or CRO industry, with a minimum of 5 years of experience in diagnostic related development. Proven track-record of a leading role in translational medicine in a relevant discipline and is a recognized thought leader in biomarkers or companion diagnostic area. Expert knowledge of biomarker, translational science, and drug development, with extensive experience working in a bioanalytical, genomic, or molecular biology laboratory and contributing to protocol development, study reporting, technological due diligence. Demonstrated expert knowledge of global regulatory environment and guidelines as related to Biomarker, Genomic Medicine, Diagnostic and Drug Development. Demonstrated experience in identifying and adopting new technologies and techniques in support of an evolving business domain with a proven record of developing and implementing strategies. Proven ability to identify and drive business opportunities for integrated offerings and partners effectively with business units to influence Parexel's strategic direction and client-facing activities. Proven achievement in leading, managing and motivating teams; ability to build and lead an empowered department or function to deliver business objectives. Significant competence in applying networking skills within Parexel and with external key opinion leaders and clients. Client focused approach to work, problem-solving, risk assessment and decision-making skills at the department and enterprise level with the ability to analyze business needs and act decisively. Excellent interpersonal, verbal and written communication skills, fluent in written and spoken English.