Sr Clinical Project Manager

Company: Relay Therapeutics
Location: Cambridge
Posted on: April 9, 2021

Job Description:

Relay Therapeutics is a new breed of company at the intersection of computation and biotechnology that is committed to creating medicines that will have a transformative impact on patients. We combine unprecedented computational power with leading-edge experimental approaches across the fields of structural biology, biophysics, chemistry and biology. This integration illuminates - for the first time - the full mobility of a protein and provides key insights into how the dynamic nature of a protein's conformation regulates function.--The team at Relay is putting this principle into practice, with the aim of accelerating the development of medicines that will make a transformative difference in patients' lives. We don't just stare hard problems in the face. We go out looking for them. Are you energized by attempting to do the impossible? We're looking for you.-- At Relay, our team is--driven--by the ultimate collaboration--across--each--of our--drug discovery disciplines. Putting protein motion at the heart of drug discovery is a challenge, but we are confident that our team's dedication and urgency will create opportunities that deeply impact the lives of the patients. Our initial programs are focused on developing therapeutics in oncology.-- Relay Therapeutics is a private company launched in 2016 with financing from Third Rock Ventures and an affiliate of D. E. Shaw Research. To date the company has raised $520M from investors including Third Rock Ventures, SoftBank Vision Fund, GV,--Casdin--Capital, BVF Partners, EcoR1 Capital,--Foresite--Capital, Perceptive Advisors,--Tavistock--Group and an affiliate of D.E. Shaw Research.-- The opportunity As--Senior--Clinical--Project--Manager, you will be accountable for--managing--clinical studies--that will lead the biopharma industry in--speed and quality of clinical study design and execution.--You will be an integrated member of the Relay Tx scientific team, responsible for the execution of clinical studies that will translate Relay's innovative science into impactful medicines for patients.--You will report to the--Director--of Clinical Operations. Your Role

• You will oversee the day-to-day operations of study execution, with a focus on site oversight from study startup to study closeout, patient enrollment, monitoring, compliance, and data flow and metrics from the clinical sites, CROs and vendors.
• You will collaborate with a dynamic Relay cross-functional team to deliver clinical studies that are on time and within budget guidelines, while ensuring quality in accordance with the protocol and ICH GCP guidelines.
• You will develop and maintain strong relationships with investigators, clinical site staff, and vendors globally, with the capability of understanding and explaining complex scientific topics to these stakeholders.
• You will develop and manage reports for communicating study progress and key metrics to Senior Management and program teams.
• You will contribute to or author key study documents including, but not limited to, protocols, informed consent forms, case report forms, study governance committee charters (e.g., data monitoring committee), study plans and clinical study reports.
• You will be accountable for effective vendor management by: serving as primary point of contact for contracted CROs and vendors,--identifying potential risks and proactively resolving issues with CROs and vendors, ensuring vendor contracts meet requirements and are efficiently executed with key performance indicators, partnering with the vendor to ensure accurate budgeting and accrual of costs throughout duration of each clinical study
• You will ensure reliable quality data are delivered by reviewing monitoring reports, protocol deviations, clinical data listings and performing or overseeing site monitoring visits, as needed.
• You will develop action plans to address protocol compliance, safety, data and administrative issues with clinical sites and CROs.
• You will coordinate with CROs on site selection, IRB/EC submissions, site initiation and close-out planning.
• You will provide oversight and ensure maintenance of clinical trial master files (TMF) to ensure compliance with required regulatory and ICH GCP quality standards and consistency with SOPs.
• You will partner with the CRO to lead, plan, and execute clinical Investigator meetings study meetings, as needed.
• You and your team will participate in preparation of regulatory filings (e.g. IND, NDA, orphan drug applications etc.) as needed.
• You will ensure inspection readiness by collaborating with CROs and providing support to clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA and external regulatory agencies.
• You will assist with the onboarding and mentoring of new or junior clinical operations associates. Your Background
  • You should ideally have 7+ years of experience in clinical study management. Sponsor experience is strongly preferred.You are recognized as a clinical operations expert, with a prior track record of success to facilitate study execution, accelerate timelines, maintain data integrity, and satisfy health authority requirements.
  • You have experience in successful execution of clinical studies across various phases. 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, and ICH GCP applicable to the conduct of clinical trials
  • You have experience in CRO, vendor and laboratory 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.
  • Ability to establish and foster relationships with investigators, vendors, and internal colleagues that support the advancement of clinical team goals and objectives.
  • 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.
  • Ability to execute the completion of tasks within defined timelines and resolve/elevate problems in a timely manner under limited direction and implementing initiative. At Relay, we believe that along with our people, our culture is our greatest asset. In fact we're proud to share we were named as one of the Boston Business Journal's "Best Places to Work " in 2017, the #1 place for small companies --in 2018 & the #2 place for small companies in 2019. To drive that culture, no one will stop you or hold you back. Instead, we will give you the tools and colleagues to push forward relentlessly and cheer you on as you go. If this resonates with you, drop us a line. Relay Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. We believe in building balanced teams and a place where our people can be their best self every day. We encourage people from underrepresented backgrounds to apply.-- Relay Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Our Culture: At Relay Tx, we believe that along with our people, our culture is our greatest asset. In fact we're proud to share we were named as one of the Boston Business Journal's "Best Places to Work " in 2017, the--#1 place for small companies --in 2018 & the--#2 place for small companies --in 2019. To drive that culture, no one will stop you or hold you back. Instead, we will give you the tools and colleagues to push forward relentlessly and cheer you on as you go. If this resonates with you, drop us a line. 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 and genetic diseases. 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 parts fearless and relentless, 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!

Keywords: Relay Therapeutics, Cambridge , Sr Clinical Project Manager, Executive , Cambridge, Massachusetts