Your Role:

• You will be the lead and an integral part of Relay’s drug product development team supporting development programs.
• You will be responsible for design, development and optimization of patient-centric (e.g. pediatric) drug product formulation and clinical / commercially viable manufacturing process including selection appropriate packaging (container closure systems) for Relay’s pipeline products.
• You will be leading and managing the outsourcing (formulation / product development and manufacturing) activities at global CRO/CMO sites, in alignment with program goals.
• You will manage prototype development/feasibility assessment and clinical manufacturing activities.
• You will support current and/or plan formulation / drug product R&D and GMP stability studies in collaboration with internal AD/QC, QA teams and third parties.
• You will be a key drug product SME for successful execution of the technology transfer of drug product processes to manufacturing site(s), providing technical in-puts / insights to the Relay’s CMOs.
• You will draft, review and approve specifications, batch records and other critical development and GMP documents.
• You will author, review and ensure completion of drug product sections of CMC-regulatory submission documents (IND, IMPD, NDA, PIP, iPSP, briefing packages etc.), responses to regulatory questions and providing supporting documentation, in a timely manner.
• You will be an asset and key member of Relay’s cross-functional teams and work collaboratively to meet the program/project objectives and key results (OKRs).
• You will evaluate and implement new and sustainable drug product technologies for Relay’s pipeline products and life-cycle management, as applicable.

Your Background/Qualifications:

• Advanced degree (doctoral or post-doctoral degree in Pharmaceutics, Pharmaceutical Sciences or related fields) and minimum of 8-10 years of relevant industry experience with proven track-record in oral solids (granules, minitablets, sprinkles/powders for reconstitution, capsules), liquid suspension formulations, manufacturing process development and optimization / scale-up thereof.
• Understanding of basics / fundamentals of pediatric product development with focus on selection of excipients, dosage form and packaging configuration for pediatric population.
• Experience with palatability assessment, taste masking and in-use stability/food-compatibility is desirable.
• Excellent understanding of the phase-appropriate IR oral formulations and manufacturing process development along with overall pharmaceutical product development process is a requisite.
• Experience and knowledge in identifying critical process parameters (CPPs), design space, design of experiments (DoE) and handling statistical programs commonly used in pharmaceutical industry.
• Knowledge of current Good Manufacturing Practices (cGMP) and experience in pharmaceutical development of new chemical entities under cGMP.
• Knowledge of CMC quality guidelines (particularly US, EU, JP and ICH guidelines) relevant to oral solid drug product development.
• Ability to author, review technical reports to support IND/NDA submission, regulatory compliance, and IP requirements.
• Exceptional organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Demonstrated strategic thinking capabilities with forward looking perspective and ability to find solutions, in alignment with management and program goals, strong communication, leadership, planning, and collaboration skills
• Exceptional attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties

Estimated Salary Range: [$143,000 - $203,000].

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 the Senior Associate/Associate Director of Portfolio and Strategy Operations, you will help ensure flawless operation of activities for a first-in-class program as it moves through clinical development while reporting to the Director of Portfolio Strategy and Operations. You will enable collaboration and alignment across key cross-functional team members such as Medical, Clinical Operations, and Pharmaceutical Development and with stakeholders in leadership.

Your Role:

• Are you flexible and fearless in the face of rapidly evolving opportunity and ambiguity? You will effectively contribute both operationally and strategically on a program moving through early clinical development.
• Do you see problems as opportunities? You will be expected to bring structure to complex and ambiguous problems, synthesize findings, develop creative / innovative options, and make logically supported recommendations. This could include helping define a molecular diagnostics strategy or monitoring drug supply/patient demand dynamics.
• Develop and maintain program timelines to ensure that all efforts are coordinated, and to identify key interdependencies, risks, and critical path activities.
• You thrive operating in a matrixed role and seamlessly facilitate cross functional discussions to drive towards shared goals and program progression.
• You will help to update and refine processes to support the team achieving key deliverables. You will also help steer content for leadership and external KOL meetings.
• You are someone who has the communication chops to build narratives, craft visuals, refine messaging and tell compelling stories as we communicate progress back to the Executive Leadership Team and Board.
• You are critical to the management and maintenance of the project long-range strategic plan, in close collaboration with your project team colleagues.

Your Background:

• You have experience (minimum 3 years) in management consulting, operations, program management and executive communication
• You have a science or management consulting background
• You are an open and candid communicator and know how to leverage your strong EQ, organizational savviness, and collaborative nature to lead and develop alignment across teams and organizations

Estimated Salary Range: [$120,000 - $200,000].

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:

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

#JO1