Manager, Clinical Science

Relay-Therapeutics; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Relay Therapeutics, a clinical-stage precision medicines company, seeks a Manager, Clinical Science to drive asset development and support the clinical strategy across cross-functional teams.

You will design studies, lead protocol development with medical writing support, and drive medical input for regulatory submissions while collaborating with Medical Leads, Clinical Development, regulatory affairs, biostatistics, data management, and medical writing to advance oncology programs.

Qualifications

• Advanced life sciences degree with 2+ years in pharma/biotech.
• Strong understanding of clinical development and study design concepts.
• Thorough knowledge of ICH and GCP requirements.

Responsibilities

• Contribute to design of clinical studies with Medical Lead and Development team.
• Lead or contribute to protocol development with medical writing input.
• Support regulatory submissions and regulatory queries related to studies.

Skills

Interpersonal skills

Organization

Planning

Scientific writing

Collaborative influence

Education

PhD/MS/PharmD/BSN with 2+ years in pharma/biotech

Job description

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.

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 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.

Your Background :

• 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

#JO1

About 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!