The Opportunity:As Manager, Clinical Science at Relay Tx, you will play a key role in driving the development of our assets and support the implementation and execution of the clinical strategy. You will work closely with clinical project management, regulatory affairs, clinical operations, biostatistics, data management, and medical writing to advance one or more clinical studies. You will have the opportunity to make an impact through providing your strategic and scientific input to cross functional teams.
Your Role: - Contribute to the design of clinical studies in close collaboration with the Medical Lead as well as Clinical Development team.
- Lead and/or contribute to protocol development with medical writing by translating the approved protocol concept into executable/efficient clinical protocols
- Drive the medical contribution together with Medical Leads to annual update of IB, DSUR liaising with cross functional teams
- Support Medical Leads to answer regulatory queries and contribute to other submissions related to studies
- Perform medical data review and analysis of study results; and review protocol deviations to identify cause and appropriate resolution.
- Contribute to the design of electronic case report forms, ensuring that eCRFs accurately capture the data intended to be gathered per protocol.
- Support data cleaning activities requiring medical interpretation and analyses of data for regulatory submissions, data disclosure and scientific publications
- Support Medical Lead to monitor real time study data to ensure the integrity of the study and the study data and working closely with clinical operations team to answer protocol related questions and resolve any study conduct issues from investigative sites
- Review and summarize relevant literature for competitive intelligence, and author and review manuscripts, abstracts, posters, etc.
- Managing communication and building strong collaborative relationships with key stakeholders both internally and externally, including interactions with academic experts, clinical trial investigators, and other clinical stakeholders.
Your Background: - Advanced degree in life sciences: PhD and/or MS, PharmD, BSN in relevant scientific field; with 2 years of experience in pharmaceutical and/or biotech industry.
- Knowledge of the clinical development process with the ability to understand concepts of various phases and principles of study design is required
- Thorough understanding of ICH, GCP, and relevant regulatory requirements is required
- Experience in early/ late phase development and oncology preferred
- Strong interpersonal, organization, planning and communication and writing skills.
- Ability to prioritize and manage multiple tasks simultaneously, being a team player, being flexible and have hands-on attitude.
- Ability to influence with collaboration, and drive decision-making within multi-disciplinary teams
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