Executive Director, Precision Medicine Companion Diagnostics
Posted on Apr 6, 2021 by Pharmacyclics
We are searching for a leader for Comparison Diagnostics with clinical trial experience to support Immunology clinical development programs. The applicant will oversee the direction, planning, execution and interpretation of clinical trials and translational research activities for clinical development programs. This is accomplished through coordination of team members across different functional groups, including discovery, regulatory, development, commercial and multiple project teams.
- Develop biomarker/translational strategic plans and manage implementation of strategies for one or more clinical programs. Responsibility may extend from early translational development activities to mature product life cycle strategies and back translational activities.
- May independently and/or with supervision, manages the design and implementation of study protocols for clinical development programs in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs
- Will lead assets-specific translational projects/teams with multiple employees in a Matrix environment. Coordinate appropriate scientific and medical activities with internal stakeholders (ie commercial, clinical operations, discovery, statistics, regulatory, etc.) to execute high quality biomarker strategies in the clinic.
- Manage the design, conduct, interpretation and reporting of biomarker data/activities in line with the development, regulatory and commercial strategies.
- With project leaders and asset-specific translational team members, ensures clinical translational sciences budgets, timelines, publication strategies and regulatory compliance requirements are factored into programs scientific activities.
- Contributes to design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.
- Lead scientific collaborations and opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies
- Pro-actively consult primary scientific literature, keep current on state of art technologies and emerging concepts in immunology.
- Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various factors
- Strong scientific background in immunology or related field supported by publication record in these areas
- MD and/or PhD with 12+ years of experience in the pharmaceutical industry or equivalent experience preferred; substantial understanding of Translational Sciences and relevant Therapeutic Area required. Will hire at level according to experience.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, biomarkers, companion diagnostics/in vitro diagnostics and experience in development strategy and the design of protocols strongly preferred.
- Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
- Demonstrated leadership in translational sciences (employing pharmacodynamic, predictive and exploratory biomarkers) and/or experience with development of assays including ligand binding assays, IHC/IF, gene expression profiling, flow cytometry a plus
- Ability to manage clinical translational programs and teams.
- Organization, orientation to details, and effective time management with an ability to adapt to changing priorities
- Must possess excellent oral and written communication skills in the English language.