BST and Clinical Biomarker Lead, Neuroscience, Associate Director
12 hours ago
Takeda is seeking a highly skilled and experienced BST and Clinical Biomarker Lead to join our Neuroscience Therapeutic Area team. As a key member of our Bioanalytical and Biomarker Science and Technologies (BST) department, you will be responsible for developing and driving translational fluid and tissue biomarker strategies for preclinical and clinical programs within Neuroscience.
You will lead collaborations with external clinical and academic experts to support development of biomarker plans, stay current on the state-of-the-art technologies and emerging biomarker concepts, and author biomarker and bioanalytical sections of clinical documents.
The ideal candidate will have a deep understanding of biomarker development and implementation in neuroscience, with 10+ years' experience in the biotechnology or pharmaceutical environment. You will also have a solid understanding of bioanalytical and biomarker strategies, applicable regulatory guidance, clinical trials, endpoints, and deliverables.
Key Responsibilities:- Develop and drive translational fluid and tissue biomarker strategies for preclinical and clinical programs within Neuroscience.
- Lead collaborations with external clinical and academic experts to support development of biomarker plans.
- Author biomarker and bioanalytical sections of clinical documents, including study protocols, regulatory documents, and communications.
- Oversee implementation of biomarker and bioanalytical plans, working with BST sub-team on vendor selection and oversight, contract executions, timely assay development and validation activities, and high-quality biomarker and bioanalytical data delivery to clinical trials.
- Represent BST at cross-functional teams and keep BST leadership informed of progress.
- PhD degree in a scientific discipline with 7+ years' experience, or MS with 13+ years' experience, or BS with 15+ years' experience.
- Extensive drug development experience, preferably in the Neuroscience TA area.
- Strong scientific background in biomarker development, various biomarker technologies, experience with assay development and validation, operational aspects, and relevant regulatory guidelines.
- Excellent communication and collaboration skills, with the ability to influence and inspire.
Takeda offers a competitive salary range of $149,000 to $234,300, depending on qualifications and experience. You will also be eligible for short-term and long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
Takeda is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a diverse and inclusive workplace and are proud to be certified as a Global Top Employer.
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