Manager, Clinical Science

Relaytherapeutics; Cambridge (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Relay Therapeutics, a leading clinical-stage precision medicines company in Cambridge, MA, seeks a Manager, Clinical Science to drive the development and execution of clinical strategies for one or more assets. You will collaborate with Medical Leads, regulatory affairs, biostatistics, data management, and medical writing to advance studies and provide strategic input across teams.

The role involves protocol design, eCRF development, data review, and regulatory submission support, with a focus

Qualifications

• Advanced degree in life sciences with pharmaceutical/biotech experience (2+ years).
• Understanding of the clinical development process and study design concepts.
• Thorough knowledge of ICH and GCP and regulatory requirements.
• Experience in oncology and early/late phase development preferred.
• Strong written, verbal, and interpersonal communication.

Responsibilities

• Contribute to the design of clinical studies in collaboration with Medical Lead and Clinical Development.
• Lead or contribute to protocol development with medical writing translating approved protocol concepts into executable protocols.
• Drive medical contributions to IB, DSUR updates with cross-functional teams.
• Support Medical Leads in regulatory queries and related submissions.
• Perform medical data review and analysis of study results; review deviations to identify causes and resolutions.
• Design electronic case report forms (eCRFs) ensuring data capture per protocol.
• Support data cleaning and analyses for regulatory submissions and publications.
• Monitor real-time study data for integrity and respond to protocol-related questions with clinical operations.
• Review literature for competitive intelligence and contribute to manuscripts and abstracts.
• Manage communications with internal and external stakeholders, including academic experts and investigators.

Skills

Interpersonal skills

Organization & planning

Communication & writing

Team collaboration

Prioritization & multitasking

Education

Advanced degree in life sciences (PhD / MS / PharmD / BSN)

Tools

ICH/GCP knowledge

Regulatory submissions experience

Job description

TheOpportunity:

AsManager,Clinical Scienceat Relay Tx, you will play a key role in driving the development of our assets andsupportthe 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 havetheopportunity to make an impactthroughproviding your strategic and scientific input to cross functional teams.

YourRole:

• 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 studyresults;and review protocol deviations toidentifycause andappropriate resolution.
• Contribute to the design of electronic case report forms, ensuring that eCRFs accurately capture the data intended to be gatheredperprotocol.
• Support data cleaning activities requiring medical interpretation and analyses of data for regulatory submissions, datadisclosureand scientific publications
• Support Medical Lead tomonitorreal 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 competitiveintelligence, andauthor 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.

YourBackground:

• Advanced degree in life sciences: PhD and/or MS, PharmD, BSN in relevant scientific field; with2years 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 isrequired
• Thorough understanding of ICH, GCP, and relevant regulatory requirements isrequired
• Experience in early/ late phase development and oncology preferred
• Strong interpersonal, organization, planning andcommunicationand writing skills.
• Ability to prioritize and manage multiple tasks simultaneously, being a team player, beingflexibleandhavehands-on attitude.
• Ability to influence with collaboration, and drive decision-making within multi-disciplinary teams

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About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.

Our team is equal partsfearlessandrelentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!