Senior / Manager, Clinical Science

The Opportunity:

As Manager/Sr. 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 medical, 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. This position will report to Director, Clinical Science.

Your Role:

• Performs clinical/medical data review and analysis of study results for safety monitoring, regulatory submissions, data disclosure, and scientific publications.
• Supports Medical Leads to monitor real time study data to ensure the integrity of the study and the study data and works closely with Clinical Operations to answer protocol related questions and resolve any study conduct issues from investigative sites.
• Review protocol deviations to trend data issues, identify cause, and action for appropriate resolution.
• Contribute to and review clinical study plans, health authority submissions and inquiries, and annual IB and DSUR updates.
• Contribute to the design, planning, and execution of clinical studies in close collaboration with the Medical Lead and Clinical Development team members.
• Lead and/or contribute to protocol development with Medical Writing by translating the approved protocol concepts into executable and efficient clinical protocols.
• Develops and maintains understanding of therapeutic disease area(s) and drug candidate including mechanism of action, therapeutic landscape, and underlying disease biology.
• Contribute to the design of electronic case report forms, ensuring that eCRFs accurately capture the data intended to be gathered per protocol.
• Contribute to program team and data/safety monitoring meetings and works cross-functionally with other departments.
• 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 and/or rare disease 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.

Estimated Salary Range: [$124,000-$177,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

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