Associate Scientific Director, Clinical Genomics, Clinical Biomarker & Technologies

Posté 18 août 2023

Billerica, Massachusetts - United States

Demander un identifiant 267222


Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.



Your Role:


• Accountable for the evaluation and execution of Precision Medicine-driven clinical genomics/NGS biomarker assays, with a specific focus on "fit-for-purpose" regulated clinical biomarker assay development, validation, transfer, implementation, and sample testing for clinical development programs.

• As a member of the Clinical Biomarker & Technologies (CBT) team, contribute to clinical biomarker and CDx testing as well as comprehensive data analysis. Collaborate closely with colleagues from various departments, including Bioinformatics, Biostatistics, Medical Leads, Medical Affairs, and Business Development (BD), to design and implement data analysis plans. Interpret biomarker and CDx results for clinical decision-making.

• Act as a Subject Matter Expert (SME) and provide support in Precision Medicine focus areas for clinical biomarker-driven hypothesis testing and generation, in accordance with biomarker development plans. Oversee the development, outsourcing, and validation of clinically applicable biomarker assays, including pharmacodynamic, predictive, prognostic, safety, and other biomarkers.

• Conduct real-world clinical genomic data mining in collaboration with Bioinformatics, Biostatistics, and Epidemiology groups, utilizing various data sources.

• Work with the global team to support regional (China, Japan, APAC) clinical biomarker-driven trials and/or regional branches of global trials.

• Proactively engage across project teams and partner lines (e.g., BD, Medical Affairs) to conduct scientific and technical reviews of novel, advanced biomarker technologies, aiming to build cutting-edge biomarker/CDx capabilities.

• Participate in the preparation of clinical biomarker study plans linked to clinical trials, in close collaboration with CBT colleagues and other relevant functions.

• Contribute to the preparation and updating of biomarker prioritization lists, aligning with other relevant functions. Also, contribute to clinical genomics/NGS biomarker/CDx content in submission documents.

• Review clinical trial documents, including but not limited to LSD, LES, CTP, and CTP amendments.

• Lead or co-lead project-related and advanced biomarker technologies-focused external and internal scientific publication efforts.

• Prepare Requests for Information (RFI), Requests for Proposal (RFP), and Scope of Work (SOW), as well as other relevant documents for vendor qualification. Support clinical outsourcing activities across project teams.

• Provide scientific and operational oversight of Contract Research Organizations (CROs) and other ancillary vendors, as appropriate. Supervise CROs to maintain high standards of productivity and quality in supporting clinical BM/CDx outsourcing practices.

• Assist in the development of global outsourcing strategies for Clinical Genomics. Contribute to the establishment and standardization of outsourcing practices and tools to support clinical studies, ensuring alignment with the company's strategy, policies, goals, and procedures.


Who You Are:

Minimum Qualifications:


• A minimum of a Bachelor's degree in Genetics, Genomics, Biology, Immunology, Pharmacology, Biochemistry, or another Science or Medical discipline.

• 12+ years of experience in a Pharmaceutical or CRO setting.


Preferred Qualifications:


• Demonstrated "hands-on" experience in "fit-for-purpose" clinical biomarker assay development within a regulated environment for clinical implementation, using a variety of technologies (e.g., Clinical Genomics, RNAseq, NGS, etc.).

• Expertise in clinical biomarker discovery and development, with advanced skills in biomarker assay design, development, troubleshooting, transfer, validation, and sample analysis.

• In-depth understanding of the scientific and operational requirements for executing biomarker and/or CDx strategies in clinical development.

• Proven experience in reviewing clinical trial-related documents in your area of expertise (e.g., LSD, LES, CTP, CTP amendments).

• Demonstrated ability to manage outsourced clinical biomarker projects within quality, timeline, and budget expectations.

• A track record of publications in clinical/translational biomarker studies, as well as contributions/authorship in documents for regulatory submission.

• Experience in oncology or immunology is preferred.


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!

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