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Vice President of Clinical Operations

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: Relay Therapeutics

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Relay Therapeutics is a new breed of company at the intersectionof computation and biotechnology that is committed to creatingmedicines that will have a transformative impact on patients.

We combine unprecedented computational power with leading-edgeexperimental 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 provideskey insights into how the dynamic nature of a protein’sconformation regulates function. The team at Relay is putting thisprinciple into practice, with the aim of accelerating thedevelopment of medicines that will make a transformative differencein patients’ lives. We don't just stare hard problems in the face.We go out looking for them. Are you energized by attempting to dothe impossible? We're looking for you.

At Relay, our team is driven by the ultimate collaborationacross each of our drug discovery disciplines. Putting proteinmotion at the heart of drug discovery is a challenge, but we areconfident that our team’s dedication and urgency will createopportunities that deeply impact the lives of the patients. Ourinitial programs are focused on developing therapeutics inoncology.

Relay Therapeutics is a private company launched in 2016 withfinancing from Third Rock Ventures and an affiliate of D. E. ShawResearch. To date the company has raised $520M from investorsincluding Third Rock Ventures, SoftBank Vision Fund, GV, CasdinCapital, BVF Partners, EcoR1 Capital, Foresite Capital, PerceptiveAdvisors, Tavistock Group and an affiliate of D.E. ShawResearch.

The opportunity

As Vice President of Clinical Operations you will be accountablefor establishing a Clinical Operations function that will lead thebiopharma industry is speed and quality of clinical study designand execution. You will be an integrated member of the Relay Txscientific team, responsible for the execution of clinical studiesthat will translate Relay’s innovative science into impactfulmedicines for patients. You will be the first clinical hire in thecompany, and will design and implement the clinical operationsprocedures and infrastructure for a rapidly growing multi-productbiopharma company.

Your role You will lead, align and manage cross-functional teamsand efforts related to clinical operations from a strategic,operational, budget and timeline aspect, utilizing internal andexternal stakeholders (including contract organizations) as needed,in order to deliver consistently high-quality results that are ontime and within budget guidelines for all Relay Tx sponsoredclinical studies across the product lifecycle, while ensuringquality in accordance with GCP and ICH guidelines

You will design and implement clinical operations systems andinfrastructure, including a hiring plan to support a growingclinical trial portfolio and standard operating procedures (SOPs)for clinical study conduct.

You will project clinical budgets and timelines, both forquarterly/annual budget planning as well as long range planning.You will be responsible for communicating these budgets andtimelines to Relay Tx management.

You and your team will develop and maintain strong relationshipswith investigators, clinical site staff, and vendors in the US andglobally, with the capability of understanding and explainingcomplex scientific topics to these stakeholders.

You and your team will contribute to or author key study orprogram related documents: protocol concept sheets, protocolsynopses, protocols, informed consent forms, case report forms,study governance committee charters (e.g., data monitoringcommittee), and clinical study reports

You and your team will be accountable for effective vendormanagement

Ensure requests for proposals (RFPs) meet user requirements, andall contracts (i.e., study sites, vendors) are efficiently executedwith key performance indicators

Partner with finance team to accurately estimate trial costs toenable the long-range planning process, and ensure teams accuratelyaccrue costs throughout duration of clinical trials

Lead all vendor governance committees

You and your team will lead, plan, and execute clinicalInvestigator meetings, study meetings, and vendor meetings asneeded

You and your team will participate in preparation of regulatoryfilings (e.g. IND, NDA, orphan applications etc.) as needed

Your background You bring 15+ years of experience in thebiopharma or CRO industry with thorough understanding of clinicaltrial processes including clinical project management, clinicalsupply, data management, and medical writing

You are recognized as a clinical operations expert, with a priortrack record of success and history of innovative program and trialexecution that utilizes the latest technologies to facilitate studyexecution, accelerate timelines, maintain data integrity, andsatisfy health authority requirements

Domain expertise in oncology drug development is must, includingexperience in executing early stage clinical trials in oncology.Late stage clinical trial experience in oncology or anothertherapeutic area is desirable.

You have a strong and current knowledge in Good ClinicalPractices and ICH Guidelines and the application to the conduct ofclinical trials

You bring successful experience from at least one fast-pacedentrepreneurial biotechnology environment

We will count on you to display strategic planning, attention todetail, and an analytical approach to problem solving

You are a leader who communicates and demonstrates vision andcommitment

You eagerly mentor and develop talent in the organization

You effectively lead by influence

At Relay, we believe that along with our people, our culture isour greatest asset. In fact we're proud to share we were named asone of the Boston Business Journal's "Best Places to Work " in2017 & the #1 place for small companies in 2018. Todrive that culture, no one will stop you or hold you back. Instead,we will give you the tools and colleagues to push forwardrelentlessly and cheer you on as you go. If this resonates withyou, drop us a line. We believe in building balanced teams and aplace where our people can be their best self every day. Weencourage people from underrepresented backgrounds to apply.

Relay Therapeutics is an equal opportunity employer and will notdiscriminate against any employee or applicant on the basis of age,color, disability, gender, national origin, race, religion, sexualorientation, veteran status, or any classification protected byfederal, state, or local law.

Our Culture:

At Relay Tx, we believe that along with our people, our cultureis our greatest asset. In fact we're proud to share we were namedas one of the Boston Business Journal's " Best Places to Work " in2017, the #1 place for small companies in 2018 & the #2 place for small companies in 2019. To drive thatculture, no one will stop you or hold you back. Instead, we willgive you the tools and colleagues to push forward relentlessly andcheer you on as you go. If this resonates with you, drop us aline.

About Relay Therapeutics

Relay Therapeutics is a new breed of company at the intersectionof computation and biotechnology that is committed to creatingmedicines that will have a transformative impact on patients.

We combine unprecedented computational power with leading-edgeexperimental 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 provideskey insights into how the dynamic nature of a protein’sconformation regulates function. The team at Relay is putting thisprinciple into practice, with the aim of accelerating thedevelopment of medicines that will make a transformative differencein patients’ lives. We don't just stare hard problems in the face.We go out looking for them. Are you energized by attempting to dothe impossible? We're looking for you.

At Relay, our team is driven by the ultimate collaborationacross each of our drug discovery disciplines. Putting proteinmotion at the heart of drug discovery is a challenge, but we areconfident that our team’s dedication and urgency will createopportunities that deeply impact the lives of the patients. Ourinitial programs are focused on developing therapeutics inoncology.

Relay Therapeutics is a public company launched in 2016 withfinancing from Third Rock Ventures and an affiliate of D. E. ShawResearch.

Keywords: Relay Therapeutics, Cambridge , Vice President, Clinical Operations, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Vice President of Clinical Operations, Other , Cambridge, Massachusetts

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