A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.
- Accountable for evaluation and execution of clinical biomarker assays in his/her field of expertise (e.g. Clinical NGS/ Genomics, RNAseq, Nanostring, mass spectrometry, protein arrays, FACS, and ligand binding assay, etc.) with specific focus on “fit for purpose” regulated biomarker assay development, validation, transfer, implementation, sample testing.
- Contribute to biomarker & CDx testing and complex data analysis: closely collaborate with colleagues from multiple departments including clinical operations, translational medicine, biostatistics and bioinformatics etc. to design data analysis plans, interpret BM and CDx results for clinical decision-making.
- Act as subject matter expert (SME) and provide support in exploratory biomarker hypothesis testing & generation according to biomarker development plan(s). He/she will oversee the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers)
- Proactively works across project teams and partner lines to perform scientific & technical review of novel biomarker technologies to build-up cutting edge biomarker/CDx capabilities with clinical application potential in supporting clinical BM and CDx efforts.
- Participate in preparation of dedicated biomarker study plan linked to a specific 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 relevant biomarker/ CDx content in submission documents.
- Contribute to review of documents from his/her area of expertise for each specific trial (including but not limited to LSD, LES, CTP, CTP amendments);
- Prepare requests for information (RFI), requests for proposal (RFP), scope of work (SOW) and other relevant necessary documents to 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.
- Assist in development of CBD outsourcing strategies. Contribute to establish & standardize outsourcing practices/tools to support clinical studies and ensure adherence to company’s strategy, policies, goals and procedures.
- Provide expert guidance for developing and utilizing assays in CLIA/CAP, GLP, GCP settings and contribute to clinical biomarker/ Companion Diagnostics (CDx) assay development, validation, transfer, monitoring and sample analyzing.
- Contribute to in-house lab clinical biomarker/CDx assay development and troubleshooting by providing technical & scientific guidance and training & fostering scientist (s) and/or lab personnel.
- Participate in evaluation & identification new or improved methodologies/techniques and provide input in clinical feasibility assessments from scientific & technical perspective.
Who you are:
- Bachelor's degree in Genetics, Genomics, Biology, Immunology, Pharmacology, Biochemistry or other Science or Medical discipline with 3+ years of experience in Pharma or CRO or Master's degree in Genetics, Genomics, Biology, Immunology, Pharmacology, Biochemistry or other Science or Medical discipline
- Bachelor's degree in Genetics, Genomics, Biology, Immunology, Pharmacology, Biochemistry or other Science or Medical discipline with 8+ years of experience in Pharma or CRO or Master's degree with 3+ years of experience in Pharma or CRO or PhD with 2 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” biomarker assay development under regulated environment for clinical implementation using varieties of technologies (e.g. Clinical Genomics, RNAseq, NGS, FACS, and ligand binding assay, 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 his/her 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 of documents for regulatory submission.
- Oncology 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 https://jobs.vibrantm.com
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.