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Clinical Research Director - I&I

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

Job Description:

Clinical Research Director, Oncology Early Development Company: SANOFI

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Clinical Research Director, Oncology Early DevelopmentCambridge, MA

At Sanofi, this is an exciting time to join our EarlyDevelopment Oncology team with our diversified and growing internalpipeline, enriched by the recent acquisition of Synthorx, onthe vanguard of gene-edited treatments. Our Oncology team isexpanding to support our growing programs, and we seek candidateswho want to create life-changing treatments for cancerpatients.

This individual will report to the project physician or projecthead, and will interface with all functions to support thedevelopment of novel anti-cancer therapeutics. This role is underthe supervision of Clinical Lead for all designated clinical studyrelated activities including but not limited to preparation,execution, reporting, strategic decision-making, investigator/AdBoard/DMC/Other External Meeting, and regulatorysubmission/consultation.

The Clinical Research Director will:

Play a key role among a group of physicians and scientistsparticularly on studies with SAR444245 (THOR-707)

Serve as Study Monitor on the assigned clinical trials, alsofunctioning as critical connection ring between strategy andexecution, acting as the medical reference in the Clinical Studyteam, ensuring the medical relevance of the clinical data

Provide support to the Clinical Lead for the assigned trials

Closely interface with Clinical Operations, Regulatory,Biostatistics, TMED, PK, Data Mgmt and all functions related tostudy conduct

Support the Clinical Lead contributing to strategy, clinicaldevelopment plans, review of pre-clinical packages

Possibly support transition of new preclinical assets to theclinic

Ensure strategic execution according to the protocol and studyplan (under direction of the Clinical Lead)

Support creating and communicating the vision for the ClinicalProgram

Design, implement, and interpret creative clinical trials whoseoutcomes define usage of the drug and create opportunities for acommercially successful product

Work transversally with colleagues from Development, MedicalOperations, Clinical Operations, Translational Research,Pharmacology, Biomarkers, Statistics, Safety, CompetitiveIntelligence, and all other functions pertinent to the project, toharmonize translating the strategy into execution in assignedstudies, to support updating the strategy based on competitiveintelligence, early clinical data, new scientific knowledge, toprepare essential clinical study documents

Prepare and review synopses, protocols and amendments, the IB,clinical sections of IND/IMPD, CTAs filings, annual reports,clinical study reports, risk-management plans, and regulatorydocuments (INDs, NDAs) under the supervision of the Clinical Leadand Project Head

Manage relations with investigators and study sites

Assist in the preparation and conduct of study trainings forinvestigators, study sites, internal colleagues

Closely monitor and support study start up, opening of sites,data collection

Support design and management of Advisory Boards (content andstrategy), strategic committees, Data Monitoring Committee and anyother ad-hoc committee meetings

Provide scientific support for clinical data review andinterpretation including safety and efficacy

Perform data interpretation and analysis to assess the impact onproject objectives and deliverables

Assess go/no go points for each indication

Participate in the preparation of registration clinicaldocumentation (labeling, CTDs, overview summaries)

If asked, participate in meetings with health authorities fordevelopment and registration purposes

Prepare responses for clinical questions from healthauthorities

Author and review clinical abstracts and presentations forconferences when appropriate

Provide feedback to the clinical study team regarding studyconduct (contribute to discussions regarding adjustments in thestudy and/or strategy based on the data)

Under guidance from and in alignment with Clinical Lead, may actas a Dedicated Project Expert (DPE), and may mentor projectScientists

Basic Qualifications:

Oncology fellowship or 2+ years of experience in Oncology

Ability to synthesize and explain complex topics tonon-experts

Ability to collaborate effectively with all personnel involvedin clinical research

Strong analytical skills including the assessment of scientificdata and medical literature. Excellent written and verbalcommunication skills

Knowledge of applicable regulatory, quality and compliancestandards

Preferred Qualifications:

3+ years industry experience or academic clinical researchexperience

Experience with immuno-oncology therapies

Experience authoring posters, oral presentations and/orpeer-reviewed papers

Ability to communicate effectively on complex medical/scientificissues and build consensus

Demonstrated ability to interact productively with and attracttop external investigators

Experience in creating and driving a clinical plan

Experience leading teams

Experience to drive project milestones and work with a globalteam

Contribution to the successful strategic development ofcompounds through phases of clinical research

Sanofi Inc. and its U.S. affiliates are Equal Opportunity andAffirmative Action employers committed to a culturally diverseworkforce. All qualified applicants will receive consideration foremployment without regard to race; color; creed; religion; nationalorigin; age; ancestry; nationality; marital, domestic partnershipor civil union status; sex, gender, gender identity or expression;affectional or sexual orientation; disability; veteran or militarystatus or liability for military status; domestic violence victimstatus; atypical cellular or blood trait; genetic information(including the refusal to submit to genetic testing) or any othercharacteristic protected by law.

#GD-SA

#LI-SA

At Sanofi diversity and inclusion is foundational to how weoperate and embedded in our Core Values. We recognize to truly tapinto the richness diversity brings we must lead with inclusion andhave a workplace where those differences can thrive and beleveraged to empower the lives of our colleagues, patients andcustomers. We respect and celebrate the diversity of our people,their backgrounds and experiences and provide equal opportunity forall.

Posted 2 Days Ago

Full time

R2554432

About Us Sanofi is dedicated to supporting people through theirhealth challenges. We are a global biopharmaceutical companyfocused on human health. We prevent illness with vaccines, provideinnovative treatments to fight pain and ease suffering. We stand bythe few who suffer from rare diseases and the millions withlong-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi istransforming scientific innovation into healthcare solutions aroundthe globe.

Sanofi, Empowering Life

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Keywords: SANOFI, Cambridge , Clinical Research Director, Oncology Early Development, Other , Cambridge, Massachusetts

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