Summary
Join Arvinas, a clinical-stage biotechnology company, as a Director, Translational Sciences – Neuroscience. You will drive translational, clinical biomarker development, and clinical imaging strategies for our neuroscience portfolio. This role requires strong scientific leadership and extensive experience in leading translational strategies in neuroscience drug development. The position reports to the VP, Translational Sciences and offers a hybrid or remote work option within the U.S. Arvinas offers a competitive compensation and benefits package. The ideal candidate will have a Ph.D. in a related field and 8+ years of experience in translational neuroscience drug development.
Requirements
- Strong expertise in neuroscience drug development with a track record in leading translational strategies across multiple stages of clinical development, from IND to NDA / BLA, and global filing experience strongly preferred
- Strong expertise of clinical biomarker development such as fluid and tissue biomarker and digital biomarker solutions, and clinical implementation in neuroscience therapeutic area. Experience with patient stratification and selection strategy in clinical implementation is a plus
- Deep understanding of various biomarker technologies, experience with assay development and validation, operational aspects and relevant regulatory guidelines
- Experience with neuroimaging modalities, including PET, MRI, and molecular imaging techniques
- Demonstrated success in working on a cross-disciplinary, drug development project team, fostering collaboration and driving shared objectives
- Excellent communication and problem-solving skills; ability to work independently as well as collaboratively, preferably experienced in navigating and influencing highly complex and matrixed environments
- Ability to work without a need for a current or future VISA sponsorship
- Ph.D. in Neuroscience, Neurophysiology, or a related life science field
- 8+ years of Biotech or Pharmaceutical industry experience in translational neuroscience in drug development
Responsibilities
- Develop and implement translational, clinical biomarker development and clinical imaging strategies in clinical trials to support Arvinas neuroscience portfolio
- Monitor execution and ensure timely fit-for-purpose pharmacodynamic/exploratory biomarker assay development and validation in partnership with external CROs and internal laboratory teams to support multi-site clinical trials for tauopathies, Parkinson’s Disease, Huntington’s disease, and other neurodegenerative diseases
- Lead the due diligence efforts on new biomarker technologies, vendor assessment/ selection to enable high quality biomarker analysis
- Manage and coach the direct report to perform as the Translational Sciences Lead to support Arvinas neuroscience clinical programs
- Lead clinical biomarker subteams and collaborate cross-functionally to align on translational fluid and tissue biomarker strategy and digital biomarker solutions, and assure effective delivery of biomarker data to support decision making in clinical studies and neuroscience portfolio progression
- Lead clinical imaging strategy and execution, including PET, MRI, and other advanced neuroimaging modalities in collaborate with imaging CROs and internal teams to implement imaging readouts in clinical trials. Ensure neuroimaging endpoints are optimized for decision-making in early and late-stage clinical trials. Provide scientific leadership on imaging data interpretation
- Participate in the planning, writing, and review of biomarker and clinical imaging related sections for Clinical Trial Protocol, Clinical Study Reports, Investigatory Brochure, Biomarker Study Reports, manuscripts/abstracts, regulatory submissions from IND to NDA
- Influence and collaborate with Discovery teams to align preclinical strategies with clinical needs and de-risk clinical development
- Collaborates cross functionally with Discovery, Clinical Development, Clinical Operations, Clinical Pharm, Regulatory, and other functions to support clinical program objectives
Benefits
- Competitive package of base and incentive compensation
- Comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families
- Group medical, vision and dental coverage
- Group and supplemental life insurance
Disclaimer: Please check that the job is real before you apply. Applying might take you to another website that we don't own. Please be aware that any actions taken during the application process are solely your responsibility, and we bear no responsibility for any outcomes.