Principal Scientist, Next Generation Sequencing and Genomics

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Job description

A career with EMD Serono is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

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 evaluation and execution of Precision Medicine driven clinical genomics/NGS biomarker assays with specific focus on "fit for purpose" regulated clinical biomarker assay development, validation, transfer, implementation, sample testing for clinical development programs
• As part of the Global Clinical Biomarkers & Companion Diagnostics (CBD) , contribute to clinical biomarker & CDx testing and comprehensive data analysis: closely collaborate with colleagues from multiple departments including bioinformatics and biostatistics, medical lead , medical affair , BD, clinical operation, etc.to design and implement the data analysis plans, interpret biomarker and CDx results for clinical decision-making.
• Act as subject matter expert (SME) and provide support in Precision Medicine Focus clinical biomarker driven hypothesis testing & generation according to biomarker development plan(s). Candidate will oversee the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers)
• Conduct the Real world Clinical genomic data mining by working with bioinformatics, Biostat and Epidemiology group using different data sources.
• Working with global team to support the regional (China, Japan , APAC ) clinical biomarker driven trials and/or global trials regional branch.
• Proactively works across project teams and partner lines (BD, Medical Affair etc. ) to conduct scientific & technical review of novel advanced biomarker technologies to build-up cutting edge biomarker/CDx capabilities
• Participate in preparation of clinical biomarker study plan linked to the clinical trial in close collaboration with CBD colleagues and other relevant functions.
• Contribute to preparation and update of biomarker prioritization lists in alignment with other relevant functions. Contribute to clinical genomics / NGS biomarker/ CDx content in submission documents.
• Contribute to review of clinical trial documents trial; including but not limited to LSD, LES, CTP, CTP amendments etc..
• Lead /co-lead the project related and advanced biomarker technologies focused external and internal scientific publication efforts .
• Prepare requests for information (RFI), requests for proposal (RFP), scope of work (SOW) and other relevant necessary documents for vendor qualification and support clinical outsourcing activities across project teams.
• Provide scientific and operational oversight of CROs and other ancillary vendors as appropriate to supervise CROs to achieve high standards of productivity and quality in supporting clinical BM/CDx outsourcing practice.
• Assist in development of CBD global outsourcing strategies. Contribute to establish & standardize outsourcing practices/tools to support clinical studies and ensure adherence to company's strategy, policies, goals and procedures.

Who you are:

Minimum Qualifications:

• Bachelor's degree in Genetics, Genomics, Biology, Immunology, Pharmacology, Biochemistry or other Science or Medical discipline with 12+ years of experience in Pharma or CRO or Master's degree in Genetics, Genomics, Biology, Immunology, Pharmacology, Biochemistry or other Science or Medical discipline with 10+ years of experience in Pharma or CRO

Preferred Qualifications:

• Bachelor's degree in Genetics, Genomics, Biology, Immunology, Pharmacology, Biochemistry or other Science or Medical discipline with 12+ years of experience in Pharma or CRO or Master's degree with 10+ years of experience in Pharma or CRO or PhD with 8 year's Pharma or CRO. experience; or Medical degree with experience in clinical biomarkers/CDx, and/or translational research in a global pharmaceutical company strongly preferred
• Demonstrated "hands-on" experience in "fit for purpose" clinical biomarker assay development under regulated environment for clinical implementation using varieties 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 scientific and operational requirement (considerations) in executing biomarker and/or CDx strategies in clinical development is required.
• Proven experience with reviewing of clinical trial related documents in candidate's area of expertise (e.g. LSD, LES, CTP, CTP amendments).
• Proven abilities in managing outsourced clinical biomarker projects within quality, timeline, and budget expectations.
• Track record of publications in clinical/translational biomarker study as well as contribution/authorship in documents for regulatory submission.
• Oncology or immunology experience preferred

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 228136

Location: Billerica

Career Level: D - Professional (4-9 years)

Working time model: full-time