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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting With Heart®? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people With Heart®.

Biomarkers and Genomic Medicine Scientific Director

Job ID 71085BR USA - Any Region - Home Based
Incredible opportunity for a a subject matter expert who is passionate about biomarker development to bring their expertise and previous assay development to Parexel's growing Genomic Medicine Team!

If you are excited about cool technologies and emerging science, have an interest in working across various therapeutic areas with multiple clients, have extensive bio analytical assay development experience, and have experience or an interest companion diagnostics, the Scientific Director opportunity will draw upon all of your passions as you provide technical leadership to teams on the forefront of novel drug development.

The Scientific Director is a recognized expert and thought leader in the field of Biomarkers, Bioanalytical and Genomic Medicine with experience in executing vision and strategy. The Scientific Director will contribute to the strategic direction of the function and is a critical member of the team reporting to the Vice President of Translational Medicine. He/she will initiate and maintain scientific and consultative relationships with clients, contribute to strategy of client programs in the bioanalytical and biomarker development domain or other related biomarker or translational medicine specialties.

Key Accountabilities:

• Provides strategic leadership, technical oversight, and scientific direction for global biomarker and bioanalytical projects, standalone or as an integral part of clinical studies working closely with highly matrix teams
• Serves as a biomarker and bioanalytical subject matter expert to engage internal and external stakeholders to develop biomarker and bioanalytical strategy and solutions (e.g. lab and assay recommendation, technical due diligence)
• Accountable for end-to-end delivery and quality review of biomarker/bioanalytical or genomic projects under his or her leadership to timelines, quality expectations, and regulatory requirements.
• Provides technical oversight and supervision of specialized laboratory vendors and solutions, review and QC biomarker/bioanalytical results to ensure quality delivery
• Address, follow up, and champion solutions on quality issues related to bioanalytical, biomarker testing. Establishes proactive communication with key internal and external clients
• Authors or contributes to the RFP responses, development of clinical protocols, clinical study reports, regulatory responses and submissions, and publications in biomarker/bioanalytical and other related translational medicine domains
• Manages the project to contract, including proactive management of budget, pass-through costs, and contract amendments where necessary
• Contributes to the development of departmental and organizational capabilities including assessing and recommending new technologies and initiating new partnership alliances in biomarker and bioanalytical space
• Provides scientific and technical leadership to support Business Development, Business Operations, and Marketing activities. Responsible for marketing and sales of the BGM capability including the development of proposals

Qualifications

Knowledge and Experience:

• Expert knowledge in bioanalytical and bioassay development (e.g. PK, PD, small molecular and large molecule biomarker, immunogenicity assay) across technology platforms and preclinical/clinical phases

• Demonstrated experience in strategizing and implementing bioanalytical and biomarker development in clinical trial settings from assay development, validation to regulatory reporting and submission

• Demonstrated experience in identifying and adopting new technologies (e.g. assay, techniques) in support of an evolving business domain across therapeutic areas

• In-depth understanding of the drug development process , with great understanding of the GXP and ICH regulatory framework

• Strong knowledge of regulatory (e.g. FDA, EMEA) requirements impacting biomarker, bioanalytical, companion diagnostic, and drug development is strongly desired

• Self-motivated with a professional attitude. Strong capacity to work effectively in a matrix environment and value the importance of teamwork

• Strong client focus, ability to analyze business needs and act decisively; demonstrated ability to make prudent decisions to achieve desired outcomes

• Demonstrated experience influencing the strategy, design, and implementation of projects and program deliverables. Ability to negotiate with respect and influence to achieve results

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. Exhibits and promotes a flexible attitude to work assignments and new learning

• Proven achievement in leading, managing, and motivating empowered teams. Models and promotes the importance of teamwork and working in a matrix environment.

• Proven consultative and negotiation skills. Effective communication and customer management experience are desired.

• Excellent stand of written and spoken English. Proficient clinical/scientific writing skills are a plus.

Education:

Ph.D. or PharmD from an accredited institution (biochemistry, molecular biology, clinical pharmacology, or related life science discipline), with over 10 years working experience in biopharmaceutical or CRO industry strongly preferred.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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