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Job Description
We seek a strong, highly collaborative geneticist to join Biogen’s Clinical Genetics team within the larger Human Genetics group. The successful candidate will support therapeutic program teams at all stages of discovery and development in the design and implementation of genetic and pharmacogenomics strategies, with a particular focus on the transition from research to clinical development. She/He will be deeply involved in one or more clinical programs, providing human genetics expertise from first-in-human studies through post-marketing, contributing to, for example, the development of clinical trial inclusion criteria, identification of sources for trial participant recruitment, and design of genetic testing strategies for the global launch of novel medicines. With Biogen’s focus on CNS diseases, incl. multiple genetics-based ASO and gene therapy programs, she/he will be a key contributor to the realization of new treatments for diseases of highest medical need.
Job Description:
Effective use of disruptive technologies is at the heart of Biogen’s strategy to discover and develop highly differentiated medicines. We are investing in translational biology, human genomics, digital technologies and advanced analytics to address scientific questions that support the discovery and development of the next generation of therapeutics.
The Human Genetics group within the Translational Biology Organization in Research and Development at Biogen generates and applies human genetic and clinical data to nominate new drug programs and anticipate success or failure of any Biogen target at all stages of the drug discovery and development process. The Clinical Genetics team acts at a critical interphase, translating early discovery findings into the clinic and establishing strategies on how to use genetics during late-stage clinical trials and for post-marketing activities.
We are looking for a successful, customer focused geneticist who can translate cutting-edge research findings to the benefit of Biogen’s drug discovery and development pipeline. This successful candidate will report into the head of Clinical Genetics.
The Scientist II will be a human geneticist, statistical geneticist, or molecular biologist, who is well-versed in clinical, diagnostic and molecular aspects of human genetics. Familiarity with neurological diseases, such as Alzheimer’s disease, Multiple Sclerosis, Parkinson’s disease and ALS is desired, along with a track record of handling or interpreting large and complex next-generation sequencing datasets generated as part of clinical trials or in research or diagnostic settings. The incumbent will be familiar with the scientific, operational, and regulatory aspects of obtaining human genetic data and have some understanding of protocol development for observational or interventional trials. She/He will partner with therapeutic area scientists, clinical and biomarker researchers, and operational teams to identify the most promising
opportunities for genetics to make a difference to the success or failure of emerging and approved therapeutics. This may include defining strategies for the identification of the most informative patient subgroups for inclusion into clinical trials and stratified data analyses, or the design of genetic testing strategies for the global launch of novel therapeutics. The successful candidate will also be responsible for identifying areas where non-interventional, natural history, and biomarker trials can help to address key questions for Biogen’s core and emerging disease areas, and to partner with internal and external stakeholders to design and execute such studies.
Expectations:
The successful candidate will have the following responsibilities.
· Contribute to the Human Genetics group at Biogen as we work to fully integrate genetics and genomics across the R&D pipeline.
· Partner with research and early clinical development teams to support application of genetics and pharmacogenomics across Biogen’s indication spectrum, with a focus on neurodegenerative disorders.
· Consult with clinical teams on application of genotyping and DNA/RNA sequencing to facilitate patient identification and assessment of inclusion criteria, recommend patient stratification strategies, and maximize opportunities for future research use of clinical trial data.
· Support drug discovery and development project teams toward implementation of genetic and pharmacogenomics strategies in clinical trials. Support clinical project teams in the design, execution, and interpretation of pharmacogenomic analyses.
· Partner with research biomarker groups and early clinical development to develop processes, protocols and ensure effective application of pharmacogenomics biomarkers.
· Initiate and manage external collaborations and vendors to support Biogen in the area of genomics and precision medicine.
· Contribute expertise on human genetics to identify or prioritize novel drug targets and to support Biogen’s broader human knowledge base
Qualifications
Minimum Experience Requirements:
· MD/PhD, MD, or PhD with at least five years of work experience in human genetics, statistical genetics, and/or pharmacogenomics or routine clinical genetic care (e.g. molecular diagnostics or genetic counselling) in an industry setting.
· Excellent communication and influencing skills. Experience in leading and working in a matrixed and multidisciplinary team environment.
· Strong understanding of genetic testing landscape, including experience with various types of genetic platforms, genetic data analysis and clinical interpretation, and communication of genetic results
· Strong understanding of the ethical and regulatory framework of human genetic data generation
· Familiarity with publicly-available and controlled-access data and resources that can be leveraged to gain understanding of benign and pathogenic variation in genes of interest
· Successful track record of working with human genetic data (as evidenced through successful IRB submissions, protocol developments, clinical trials conducted/participated in, or seminal publications)
Preferred Qualifications:
· Experience in clinical trial design, protocol language drafting
· Experience in working with disease cohorts and human population biobanks
· Strong understanding of population genetics
· Successful track record in applying genomic (genetic and transcriptomic) technologies to drug discovery and development, incl. knowledge of ADME and safety pharmacogenomics programs
· Knowledge of regulatory requirements, policies and guidelines for the interrogation of genetic and genomic markers in the clinical trials, incl. experience with regulatory interaction
Additional Information
All your information will be kept confidential according to EEO guidelines.
Vacancy expired!