Biomarker Group Leader (Principal Scientist)
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Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
At Roche we create transformative medicines to tackle some of the worlds toughest unmet healthcare needs for patients. At CICoR we aspire to serve patients by leveraging Chinas life science ecosystem to accelerate scientific innovation and develop breakthrough medicines. Together we cultivate a culture defined by curiosity responsibility and humilityone where our talented people are empowered and inspired to deliver extraordinary life-changing innovation at speed.
The mission of our biomarker team is to accelerate early-phase clinical development through effective patient selection and enrichment and generation and analysis of clinical biomarker data. These efforts enable proof-of-mechanism (PoM) demonstration and deeper disease understanding supporting faster and more confident addition we provide biomarker expertise to discovery projects to elucidate the molecular pathways that drive disease.
We are seeking a highly motivated individual to lead the biomarker this role you will strategize and deliver rigorous biomarker support across multiple disease areasincluding Oncology Immunology Neurology Cardiovascular & Metabolism and Ophthalmology advance translational science in China. You will ensure strong contributions to programs in both early- and late-stage clinical development by collaborating with cross-functional teams in China and globally as well as with key TAEs and CROs in China.
Roles and Responsibilities
Lead and mentor a multidisciplinary team of biomarker experts while also serving as an hands-on individual contributor.
Define and drive the China biomarker strategy for early and late-phase clinical development programs including providing program-specific feasibility assessments and execution plans.
Serve as the biomarker subject matter expert on clinical development project teams advising on disease biology and biomarker science.
Support the generation and review of critical clinical development documents (e.g. protocols ICFs) to ensure alignment with biomarker strategies.
Partner with global biomarker and project teams to lead the execution of biomarker studies including data analysis interpretation and reporting.
Integrate preclinical clinical and real-world data to guide indication selection and develop patient enrichment strategies to increase the probability of clinical success for CICoR programs.
Design and lead forward and reverse translational research studies in collaboration with internal and external partners to support the preclinical and clinical portfolio.
Stay abreast of novel biomarker modalities and technologies to drive the prioritization and harmonization of biomarker platforms across the portfolio.
Lead biomarker assay outsourcing efforts including overseeing assay development transfer validation and execution at CROs for both non-clinical and clinical studies.
Ensure data integrity through critical review and validation of CRO-generated results.
Identify select and manage external vendors and institutional collaborators to ensure the timely delivery of high-quality data.
Qualification
PhD or MD in a relevant scientific field (e.g. Molecular Biology Cell Biology Oncology Immunology etc.).
Minimum of 5 years of pharmaceutical industry experience in Translational Medicine Clinical Development or Biology research with a strong preference for candidates possessing a background in biomarker research or clinical biomarker development.
Proven experience in E2E clinical drug development including drafting relevant documents (e.g. protocols ICFs) and a solid understanding of cross-functional interfaces such as Clinical Science Clinical Pharmacology Regulatory Safety Operations and Biostatistics.
Deep familiarity with the regulatory landscape and competitive environment in China.
Extensive knowledge of state-of-the-art biomarker technologies including immunoassays NGS IHC FACS PCR and imaging-based modalities (MRI/DXA/PET).
Demonstrated expertise in generating and interpreting data from diverse sample types to establish proof of biology support dose selection and develop patient enrichment strategies.
Thrives in a dynamic inclusive environment taking full accountability for personal contributions and development.
Resourceful and flexible problem-solver capable of working collaboratively while ensuring cross-team alignment.
Transparent and empathetic leader with strong coaching skills and a commitment to keeping teams informed and engaged.
Strategic thinker with a holistic ecosystem-oriented mindset coupled with strong analytical abilities.
Excellent communication and interpersonal skills in both English and Chinese with the proven ability to influence stakeholders and drive consensus.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Staff IC
Key Skills
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
