Scientific Director, Precision Medicine Immunology
Posted on Apr 5, 2021 by Pharmacyclics
The candidate will:
- Lead the development and implementation of precision medicine and biomarker strategic plans for one or more clinical programs. Responsibility may extend from early translational development activities to mature product life cycle strategies and back translational activities.
- Oversee and manage the design, conduct, interpretation, and reporting of biomarker data/activities in line with the development, regulatory, and commercial strategies.
- Ensure, in collaboration with project leaders and asset-specific translational team members, that clinical translational sciences budgets, timelines, publication strategies and regulatory compliance requirements are factored into programs scientific activities.
- Lead asset-specific precision medicine projects/teams in a Matrix environment.
- Oversee and coordinate operational aspects such as sample management, technical validation of assays both internally and at external CROs, review of SOWs, and data management.
- In collaboration with appropriate stakeholders ensure that clinical translational budgets, timelines, publication strategies, and regulatory compliance requirements are incorporated into program strategy.
- Author and review all translational medicine aspects of clinical and regulatory documents including development plans, study protocols, clinical study reports, and regulatory submissions.
- Lead scientific collaborations and therapeutic area key opinion leader interactions in collaboration with partners from Medical Affairs, Commercial, or other functions.
- Proactively consult primary scientific literature, keep current on state of art technologies and emerging concepts in immunology.
- PhD, PharmD and/or MD with 10+ years or MS with 15+ years of experience in the pharmaceutical industry or equivalent; substantial understanding of precision medicine/translational science required. Will hire at level according to experience.
- Strong scientific background in immunology or related field supported by publication record in these areas.
- Demonstrated leadership in precision and/or translational sciences (employing pharmacodynamic, predictive and exploratory biomarkers) and experience with relevant assay and sampling technologies.
- Expertise in dermatology, rheumatology, and/or gastroenterology highly desirable.
- Familiarity with data management and visualization tools and collaborating with computational biology to analyze complex data sets emerging from clinical trials.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics, protocol design, and/or experience in development strategy preferred.
- Experience in managing direct report desirable.
- Ability to manage clinical translational programs and teams with moderate supervision.
- Excellent written and oral communication skills, ability to present results in a clear and concise manner, strong organizational skills with attention to detail, and effective time management with an ability to adapt to changing priorities.
- Strong interpersonal and collaboration skills to work in a team-oriented, Matrix environment, and the ability to work through conflicts
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