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Sr. Manager, Clinical Science
Cambridge, MA 02139 US
- Contributes to the development of the clinical development plan for the designated product/indication in collaboration with Project Leaders and the Medical Directors.
- Leads and/or contributes to the development of core clinical documents (e.g., clinical protocol synopsis, clinical protocol, TLFs, committee charters and clinical study report), ensuring they are written in accordance with pharmaceutical industry practices and regulatory guidelines.
- Ensures clinical data being collected are aligned with strategic objectives and regulatory reporting requirements.
- Monitors and evaluates clinical data as a basis for the development and design of the clinical drug program/portfolio.
- Remains current on scientific developments, trends and innovative practices that may impact the clinical development organization and the work that the members individually and collectively perform.
- Contributes to the selection of clinical outcome measures to be assessed in clinical studies
- Applies lessons learned from other trials to subsequent clinical trial activities.
- Collaborates with the Medical Director(s), clinical operations, data science, and pharmacovigilance to support program operations
- Conduct reviews of the clinical study data and collaborate on the overall data quality plan.
- To optimize clinical protocols and development plans, performs reviews of regulatory guidance/guidelines, medical literature and new technologies; seeks input from various R&D functions.
- Suggests alternate study designs to address study objectives and improve quality and timeliness
- Facilitates continuous learning and knowledge transfer throughout the project lifecycle.
- Supports project team training of study protocols
- Contributes to process improvement within clinical development
- Selects and liaises with extramural consultants, such as Data Safety Monitoring Board and Steering Committees.
- Builds and maintains relationships with external investigators and key opinion leaders.
- Serves as the scientific point-of-contact for questions associated with an assigned study(s) or program(s) from internal functions, such as clinical operations, or externally (e.g., study sites, vendors)
- Bachelor’s degree in Life Sciences or equivalent; advanced degree, such as master’s in science, PhD or PharmD is preferred.
- 5 to 7 years pharmaceutical industry experience in clinical drug/biologics development and the associated regulatory processes.
- Experience across Phase I-III drug development projects is required, with a focus on product development in therapeutic areas in line with Ono’s pipeline (e.g., oncology, immunology, neurology).
- Knowledge of International Conference of Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations and other guidelines.
- Strong data analysis and problem-solving skills.
- Excellent communication and presentation skills.
- Ability to interact with internal team members and external partners to effectively to inform on the objectives and endpoints of a study and rationale for the study procedures and their timing.
- Strong organizational skills to ensure that necessary data collection and documentation is accomplished for the required analysis and interpretation of clinical trial results.
- This role requires the incumbent to travel up to 30% of the time.