Translational Sciences / Translational Operations Manager
Constellation Pharmaceuticals is a clinical-stage company with a focus on the development of novel molecules targeting chromatin regulatory proteins in tumor and immune cells for therapeutic applications in oncology. Our translational capabilities are currently being expanded to ensure the differentiated clinical development of our clinical and pre-clinical assets, and we seek talented and experienced individuals who want to participate in developing novel cancer therapeutics. We believe we are #BrighterTogether!
As an integrated function within the Translational Sciences Department, this position will be responsible for clinical biomarker sample logistics, management and testing, clinical biomarker data management, and the development of the translational biomarker sections in clinical documents. You will report to the head of clinical biomarker/CDx group within the Translational Sciences Department to support the implementation of biomarker strategies for all clinical stage programs, and interface with the Clinical Operations Team and CROs to operationalize clinical biomarker assays for each clinical study.
How you will spend your day:
- Work with Translational team leads to understand the rationale and technical specifications of the biomarker assays used in ongoing and upcoming clinical studies
- Work with Clinical Operations to guide the establishment, implementation and improvement of clinical sample logistics (collection, shipping, storage and processing) across the entire clinical portfolio
- Provide technical guidance in sample collection kit building
- Draft and review the biomarker sections of clinical protocols, lab manuals and study reports as needed
- Work as the point person with biomarker vendors and academic collaborators to manage biomarker sample testing, from contract negotiation all the way through timely delivery of high-quality biomarker results
- Compile and manage clinical biomarker data internally and through contracted external database
- Manage and maintain translational sample inventory database
- Identify and manage clinical sample vendors in support of biomarker assay development
Key things about you:
- Previous experience in clinical biomarker sample management and testing, biomarker data management, and CRO management
- Experience working closely with collaborating functions, such as translational sciences, clinical operations, legal and finance
- Broad experience with various types of clinical biomarker assays and a solid understanding of sample collection, processing, and shipping requirements
- Excellent communication skills, detail-oriented, capable of managing timelines and deliverables, with a true sense of ownership for assigned tasks
- BS/MS degree with at least 7 years of relevant experience with a minimum of 4 years in industry
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Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.