Description
Summary
The AssociateDirector, Clinical Science will be a key contributor to the scientific, clinical, and operational scope of clinical development programs in both inflammation/immunology and oncology, with an emphasis on program-specific activities.The AssociateDirector, Clinical Science will help drive the design, planning, and implementation of study protocols for assigned investigational products and will play a key role in supporting related regulatory activities. This role will work on cross-functional study management teams for the design, execution, and monitoring of clinical trials, as well as data interpretation and communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department.
Responsibilities
- Partner with cross-functional study-level teams tohelp drive the conduct of our earlyclinical studiesin inflammation, with potential to also work on oncology studies. These activities include operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety monitoring, preparation of status update reports, and study close-out activities.
- Analyze clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments.Assist in communicating a clear overview of trial results to program teams.
- Perform safety/efficacy data reviews. Will be responsible for assessing issues relating to protocol conduct and/or individual subject safety.
- Support senior team members with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs.
- Provide organizational support for Data Monitoring Committees and other applicable data review committees, including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
- Author clinical protocol synopsis, and contribute to authoring of clinical study protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents.
- Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations.
- Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences, and publications.
- Support publication strategy execution including collaboration with investigators, KOLs, medical affairs and other internal/external stakeholders.
- Present at investigator meetings and site initiation visits.
- Conduct literature reviews as needed.
- Line management of junior clinical scientists.
Qualifications
- PhD degree in health science field, PharmD, MD or non-US equivalent, or other relevant advanced degree in a health science field.
- 5+ years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role.
- Experience in inflammation and/or immunology clinical trials required
- Experience with data analysis and interpretation as an understanding of safety and pharmacovigilance principles required.
- Ability to think innovatively, and tactically with an interest in clinical research and drug development.
- Demonstrated ability to evaluate, interpret and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategy.
- Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Must be willing and possess the expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently as appropriate. Flexible to accommodate changes in team and project needs.
- Ability to handle multiple projects at a time and have a strong attention to detail whileunderstanding the higher-level strategy.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to make independent, timely and appropriate decisions.
