The Opportunity:

Relay Therapeutics is seeking a highly motivated Scientist to join our Drug Discovery team in a unique hybrid role that integrates synthetic chemistry with cheminformatics. This position is ideal for a scientist who enjoys working at the interface of experimental and computational disciplines and is excited to help shape how data-driven chemistry is done in a modern biotech environment.

Your Role:

• Maintain and support tools used in compound registration, lab operations and data ingestion from assays, as well as broader data and software access workflows
• Design and execute synthetic chemistry workflows, with a focus on high-throughput or parallel synthesis to support medicinal chemistry programs
• Contribute to the design, enumeration, and prioritization of compound libraries using cheminformatics tools
• Collaborate closely with computational chemists, data scientists, and medicinal chemists to guide compound design using data-driven insights
• Analyze and interpret experimental data to inform structure–activity relationships (SAR) and compound optimization
• Help develop and refine internal workflows that integrate synthetic chemistry with computational approaches
• Maintain clear documentation and communicate results effectively across multidisciplinary teams

Your Background:

• Ph.D. or M.S. in Organic Chemistry or a related field, with 2–5 years of relevant industry experience preferred
• Demonstrated experience in synthetic organic chemistry
• Familiarity with cheminformatics tools and concepts (e.g., molecular representations, library design, property prediction)
• Experience with scripting or data analysis tools (e.g., Python, RDKit)
• Strong problem-solving skills and the ability to work both independently and collaboratively
• Excellent communication skills and a desire to work in a highly cross-functional environment

What We’re Looking For

• A scientist who enjoys bridging “hands-on” chemistry with computational thinking
• Someone comfortable working in a fast-paced, evolving biotech setting
• A candidate who is curious, adaptable, and interested in shaping new ways of integrating chemistry and data science

Estimated Salary Range: [$88,000-$126,000].

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.

#BP1

The Opportunity:

As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.

Your Role: 

• You will serve as CMC-regulatory lead for assigned projects.
• Develop and execute CMC global submission plans and timelines in accordance with project goals
• You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmaceutical Development leads/SMEs.
• You will be responsible for coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs.
• You will lead CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC/PD, regulatory affairs and/or program management, as applicable.
• You will lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with CMC leadership.
• You will keep abreast of regulatory guidance and technical/scientific developments relevant to projects.

Competencies:

• Strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions.
• Proven ability to lead and manage regulatory CMC projects with minimal supervision
• In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH).
• Positive attitude, energetic and proactive.
• Strong technical writing and document review skills.
• Excellent organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Strategic thinking capabilities with forward looking perspective and ability to find solutions, in alignment with management and program goals, strong communication, planning, and collaboration skills
• Attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties.
• Ability to effectively manage multiple projects with competing priorities.

Your Qualifications:

• Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields.
• Minimum of 8+ years of relevant experience in regulatory-CMC and/or within CMC function (e.g. analytical, formulation and process development, QA, QC) in the biotech/pharmaceutical industry with a focus preferably on CMC for small molecules and oral solid products.
• Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance.
• Knowledge of eCTD Module 3 and QOS requirements for INDs/IMPDs and NDAs/MAAs.
• Experience managing submissions in RIM Veeva or equivalent; document formatting/Quality Control compliant with eCTD templates / requirements.
• Authoring experience of CTD Module 2 & Module 3 sections.

Estimated Salary Range: [$145,000 - $207,000].

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.

#BP1

The Opportunity:

As Associate Director, Data Management, you will be accountable for delivery, integrity, and quality of Relay’s clinical data across the clinical studies. You will be an integrated member of the Relay Tx scientific team, responsible for the in-house data management expertise for the execution of clinical studies that will translate Relay’s innovative science into impactful medicines for patients. You will report to the Senior Director, Clinical Data Management.  

Your Role:  

• You will be responsible for oversight and execution of data management activities for assigned clinical programs including data timelines and key deliverables.  

• You will work directly with and oversee CROs and vendors for outsourced Data Management activities. Is responsible for CRO performance and data management metrics for assigned programs. 

• You will lead database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals.  

• You will lead data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., manual data review guidelines, computerized edit check programs, Data Management Plans (DMP). 

• You will be responsible for executing or overseeing data cleaning activities through to database lock: includes generating and managing clinical trial data queries, data review listings, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events and central labs.  

• You will collaborate with a dynamic Relay cross-functional team to ensure timeliness and quality of data deliverables. 

• You will ensure compliance with global regulatory requirements and quality standards. 

• You will contribute to data standards including CRF and participate in data system development initiatives and database integration projects. 

• You will participate in SOP development, training of junior data managers, process mapping, and other departmental activities. 

Your Background:  

• You should ideally have 7+ years of experience in the pharmaceutical / biotechnology industry as a Data Manager.  Sponsor experience is strongly preferred. 

• You have advanced experience with data collection and cleaning covering Phase I, II and III studies. Oncology experience is preferred. 

• You have experience in executing clinical studies across various phases is desirable.  Expertise in oncology drug development is preferred.         

• You have a strong and current knowledge in global regulatory and compliance requirements including but not limited to US CFR, EU CTD, ICH GCP, and CDISC.       

• You have experience in CRO and vendor oversight.          

• You are a motivated self-starter who is capable of flourishing in a fast-paced small company environment. 

• You are a creative problem-solver with excellent communication and public speaking skills.          

• You have strong interpersonal and organizational skills, with a high degree of attention to detail.       

• You are pragmatic and able to manage multiple projects and needs effectively. 

Estimated Salary Range: [$146,000 - $208,000].

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.

#BP1

The Opportunity

We are seeking a highly motivated Manager of Financial Planning & Analysis (FP&A) to join our established finance team at a well-positioned, clinical-stage precision medicine company in Kendall Square. This is an excellent opportunity for a finance professional who thrives in a dynamic, collaborative environment and is eager to make a meaningful impact across the organization.

This role will report to the Senior Director of FP&A and will play a key role in supporting our development organization through accrual reporting, planning, and analytical activities as well as supporting our recurring management reporting deliverables

Your Role

• Track and analyze clinical site budgets, providing visibility into spend and key trends
• Support the analytics for our clinical trials including the clinical accruals process, and business partnering with key cross-functional stakeholders
• Preparation and delivery of key monthly reporting including monthly financial reporting and headcount analytics
• Trusted FP&A business partner to our G&A departments (Finance, IT, HR, Legal, and Operations)
• Perform ad hoc financial analysis to support decision-making across the development organization
• Assist with budgeting, forecasting, and long-range planning processes
• Prepare presentations and materials for cross-functional partners, translating data into clear and compelling financial insights
• Continuously improve financial processes, models, and reporting tools

Your Background

• Bachelor’s degree in Accounting, Finance, or related field (required)
• 5+ years of progressive experience in finance or accounting (biotech or life sciences experience preferred)
• Strong proficiency in Microsoft Excel and PowerPoint (required)
• Experience with Adaptive Planning or similar financial planning tools (preferred)
• Solid understanding of financial statements, budgeting, and forecasting processes
• Strong analytical, problem-solving, and communication skills
• Ability to manage multiple priorities and work effectively in a fast-paced environment
• Detail-oriented with a high degree of accuracy and accountability

Why Join Us?

• Join a collaborative, well-established finance team
• Contribute to a mission-driven company making a meaningful impact for patients
• Gain exposure to cross-functional teams and senior leadership
• Opportunity for growth and professional development

If you're looking to take the next step in your finance career and want to contribute to a high-impact organization, we’d love to hear from you.

Estimated Salary Range: [$98,000 - $140,000].

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.

#BP1

The Opportunity: 

We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to ​define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the global regulatory lead on relevant project teams ​to formulate and execute development strategies for developmental programs. You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions. 

Your Role:  

• You will work side by side with your regulatory and research and development colleagues to develop​ and execute innovative regulatory strategies for our fast-paced programs, including the implementation of non-clinical and clinical regualtory strategy for relevant products. 

• You will be responsible for leading the preparation and submission of high quality domestic and global regualtory submission documents (i.e. IND, CTA, NDA/MAA), as well as leading the development of response strategies to regulators. 

• You will be responsible for communicating with the global regualtory authorities and leading the preparation and conduct of meetings with health authorities, which includes the development of robust briefing packages and comprehensive meeting preparation to maximize outcomes of meetings. 

• You will be responsible for integrating your knowledge of current legislation, guidelines and other regualtory intelligence into the development strategies and ensuring compliance with regualtory filing and reporting requirements.  

• You will be responsible for proactively identifying regulatory opportunities and risks and proposing alternative approaches and mitigations to resolve development program challenges. 

• You will lead the efforts to plan and obtain ​regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations and contribute to the CDx strategy development and submissions.  

• You will provide oversight to the global regulatory activities ​that are performed by our Clinical Research Organization (CROs) and regulatory vendors.  

Your Background:  

• You have earned your B.S and/or M.S. and bring at least 5 years of increasing responsibility in regulatory affairs. Advanced degree or education in a scientific field is a plus. 

• You are results-oriented and have comprehensive knowledge of the drug development process and have a demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc.) 

• Experience in precision oncology, rare disease​ and/or companion diagnostic (CDx) is a plus. 

• You are a regulatory interpreter; you have experience in interpretation of regulations, guidelines, and policy statements and know how best to exercise regulatory flexibility. 

• You are a strategic thinker, capable of proposing innovative solutions to regulatory problems. 

• You have strong verbal and written communication skills, including the ability to present strategic topics/issues to project teams, management and regualtory agencies. 

• Self-motivated and driven with a proactive and flexible working style with a passion for impacting patient's lives through regulatory work. 

Estimated Salary Range: [$144,000 - $205,000].

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.

#JO1

The Opportunity 

We are seeking a highly motivated and strategic leader to direct analytical development and quality control strategies in support of drug substance and drug product development across all stages of development. In this role, you will establish and lead the analytical strategy for our small molecule programs and serve as a key partner across CMC, Regulatory, and Quality functions. 

You will work closely with internal stakeholders and external partners, including CMOs and CROs, to ensure robust analytical methods and quality systems are implemented to support development, manufacturing, and regulatory submissions. 

This is a highly visible leadership role with responsibility for shaping analytical strategies that enable the successful advancement of our clinical pipeline. 

Your Role 

• You will be responsible for setting and executing the analytical development and quality control strategy across our development programs, ensuring phase-appropriate analytical methods and control strategies are in place to support drug substance (DS) and drug product (DP) development. 

• You will lead analytical method development, validation, and lifecycle management activities required for the full characterization of small molecule NCEs. 

• You will provide scientific and strategic oversight of external laboratories, CMOs, and CROs conducting analytical development, method validation, release testing, and stability testing in support of Relay clinical candidates. 

• You will review and approve analytical development strategies, method transfer and validation protocols, datasets, and final reports. 

• You will oversee QC testing performed at external analytical laboratories and DS/DP manufacturing sites to ensure compliance with cGMP standards. 

• You will provide quality oversight and approval of cGMP QC documentation, including change controls, deviations, CAPAs, analytical procedures, and validation protocols. 

• You will review analytical data packages and raw data from third-party laboratories to support batch disposition and release. 

• You will oversee the Reference Standard program, including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories. 

• You will lead activities related to critical quality attributes (CQAs), specifications, stability strategies, data trending, shelf life determinations, and expiry dating for drug substance and drug product. 

• You will define and implement phase-appropriate analytical and stability strategies across all clinical development programs. 

• You will author and review QC and analytical sections of regulatory filings, including INDs and NDAs, and provide technical leadership for responses to Health Authority questions. 

• You will represent the analytical function in cross-functional program teams and contribute to overall CMC strategy and regulatory planning. 

• You will build strong partnerships across Regulatory Affairs, CMC, Quality Assurance, and external partners to ensure alignment on development and regulatory strategies. 

• As the analytical function grows, you may mentor and lead internal scientists or matrix teams, while establishing scalable processes and best practices. 

Your Background 

• You have earned an MS or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or a related discipline, with 10+ years of industry experience, including significant experience leading analytical development activities in a pharmaceutical or biotechnology environment. 

• You have deep expertise in analytical development, method validation, technology transfer, troubleshooting, and quality control for small molecule drug development. 

• You have experience developing analytical strategies across multiple phases of development, including IND-enabling and late-stage programs. 

• Experience supporting regulatory filings (IND, NDA, or equivalent) and interacting with global regulatory agencies such as the FDA, EMA, or PMDA is strongly preferred. 

• You possess strong technical expertise in analytical methods for small molecule drug substances and oral solid dosage forms. 

• You are an effective communicator who can collaborate successfully with cross-functional internal teams, contract laboratories, and manufacturing partners. 
• You are comfortable managing multiple programs and priorities in a dynamic development environment.

Estimated Salary Range: [$160,000 - $228,000].

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.

#BP1

The Opportunity:

As a Senior / Medical Director at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to registration.  Specifically, you will collaborate with senior medical staff to drive clinical strategy, clinical trial design, and execution.  Working cross-functionally with clinical project management, regulatory affairs, clinical operations, biostatistics, data management and medical writing, you will play a key role as Relay Tx continues to introduce product candidates into the clinic.  You will provide clinical leadership to R&D teams and will work closely with Development leadership.   

We are open to remote employees

About You:  

• Collaborate with senior medical staff, drug discovery teams, translational oncology, clinical operations, clinical investigators and disease-specific experts to design and execute early clinical development plans that definitively test key translational hypotheses for Relay Tx medicines and establish clinical proof-of-concept as soon as possible after entering human testing. 

• Write clinical sections of key documents, including Investigator’s Brochures, IND summary documents, CTAs for initiation of ex-US studies and work with senior medical staff for responses to questions from regulatory authorities, IRBs, and ethics committees. 

• Provide expert medical review, assessment, and interpretation of clinical data and prepare results for presentation to internal clinical development leadership and external stakeholder including regulatory authorities.  

• Manage drug safety and pharmacovigilance activities for ongoing trial(s). 

• Attend and support clinical site initiation visits. 

• Rapidly integrate new insights derived from on-going Relay Tx or external clinical trials, translational science or basic science into Relay Tx development plans and clinical trial activities. 

• Collaborate with research leadership and drug discovery teams to shape the Relay Tx drug discovery portfolio. 

• Proactively manage communication and build strong collaborative relationships with key stakeholders.

• Ensure Relay Tx maintains the highest standards of compliance and ethical behavior in the design, conduct, interpretation and communication of clinical trials, clinical trial data, and clinical trial results. 

Your Background:  

• Experience working with solid tumors.
• A dynamic team player and effective communicator that thrives in a fast-paced environment. 
• MD, MD/PhD or other advanced degree with 5+ years of clinical development experience in academic and/or industry settings with work in oncology.  Motivated candidates with lesser experience and a passion to learn precision oncology clinical development and contribute to cross functional development teams will also be considered.
• Exposure to design and execution of clinical trials; protocol development and design, development of case report forms, and statistical analysis plans. 
• Exposure to working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials. 
• Excellent written and oral communication skills. 
• The successful applicant will thrive in the Relay Tx corporate culture where the core values are relentless, fearless, craftsmanship, candor, and humanity. You will be a key contributor to Relay clinical development and enabled to make a significant positive impact for patients. 

Estimated Salary Range: [$213,000 - $350,000].

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.

#JO1

**Please apply via the link below**

Regional Medical Science Liaison - BC/Oncology - South Korea

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