15h Left: Clinical Lead, I&I Position Available In Middlesex, Massachusetts

Job Description:

Job Title:

Clinical Lead, I&I Location:

Cambridge, MA orMorristown, NJ About the Job Are you ready to shape the future ofmedicine? The race is on to speed up drug discovery and developmentto find answers for patients and their families. Your skills couldbe critical in helping our teams accelerate Progress. The ClinicalLead is the primary clinical lead for a clinical developmentprogram, reporting into the Global Project Head (GPH), and leadinga team of Clinical Research Directors and Clinical scientists. Therole requires a well-organized, experienced, strategic focused andresourceful individual with interpersonal skills, self-motivation,solid analytical skills and the ability deliver to multipleoperational tasks. The role will focus on autoimmunity with directclinical accountability on key programs in this field. The role ofthe Clinical Lead is to:

• Lead the clinical development planstrategies and implementation for auto-immunity programs in I&Iindications and coordinate clinical activities across indicationsand TAs
• Lead a clinical team including CRDs and clinicalscientists.
• Oversee and support study related clinicalactivities, e.g. protocol development, pressure test and clusterfeasibility, medical review and validation of clinical data, studyrisk assessment
• Support and input preparation of internalgovernance milestones
• Oversee and contribute to the clinical partof submission dossier for their projects: Common Technical Documentfor

FDA & EMA

submission, filing in Japan and China and answers toquestions from health authorities

• Provide appropriate medicalinput & support for all activities related to clinical studies suchas medical training, feasibility, medical review of data, medicalinformation for the study team, medical advisors/Clinical ProjectLeaders from Clinical Study Units, and investigators
• Coordinatewith CRDs in the project, Global Project Head, The PV Rep,Regulatory
• Provide expertise in the fields of clinicaldevelopment and autoimmune conditions.
• Lead/Act as a mentor forCRDs and Clinical Scientists on a same project/TA
• Collaboratewith functions to ensure uniform, aligned operational approach (e.

gharmonizing study documents, ES, protocols, etc). Within a project,ensure leadership, build consensus, coordinate action plans withCRDs and stakeholders to resolve project-related study issues,anticipates potential issues (sharing lessons learned) across theproject or study teams. We are an innovative global healthcarecompany with one purpose: to chase the miracles of science toimprove people’s lives. We’re also a company where you can flourishand grow your career, with countless opportunities to explore, makeconnections with people, and stretch the limits of what you thoughtwas possible. Ready to get started?

Main Responsibilities:

Clinicaldevelopment plan strategies:

• Clinical strategy: Develop andassess clinical scenarios in alignment with GPH

• InternalGovernance:

  Preparation of documents and presentations for internalgovernance meetings

• Collaborate with CRDs within the project,ensures leadership, builds consensus, coordinates action plans withstakeholders to resolve project-related study issues, anticipatespotential issues (sharing lessons learned) across the project orstudy teams
• Contribute to the definition of the product valueproposition (TVP), TPP and market access strategy (in collaborationwith respective functions) and the focus of the research strategy,by providing input on existing clinical needs and approaches toclinical development strategies for research projects
• Engage andcollaborate with internal and external partners, regulators, andexperts Execution of clinical development and studies activities
• Lead and oversee study implementation and remediate study issues
• Review and validate the clinical study report and key results memos
• Oversee and is accountable for study related clinical activities
• Develop the abbreviated protocol
• Review and validate thefinal protocol, protocol amendments and study supporting documents
• Co-Develop the SAP in collaboration with bio stats
• Responsiblefor key results preparation and clinical study report
• Assisted byrelated functions (e.g. clinical operations, project management,and procurement), responsible for timelines, budgets andcontingency/risk management plans to assure successful execution ofthe clinical trials in compliance with Good Clinical Practice(GCP), applicable laws and regulations as well as applicablestandard operating procedures (SOPs)
• Medical support to clinicaloperation team during the clinical feasibility
• Ensure continuousmedical review of aggregated data during clinical trial conduct(DRSR, safety, stat outputs of blinded data, …) with clinicalscientist, bio stat and GSO
• Lead the study specific committees(IDMC, steering com, adjudication …) with operational support
• Answer to medical questions raised by EC/IRBs, sites Contributionto regulatory and safety documents and meetings:
• Representshis/her project at key regulatory agency meetings as the medicalspokesperson for the studies and project.
• Oversee and isaccountable for clinical input in key regulatory documents : Reviewand/or contribute in the the clinical section of the Investigator’sbrochure, CTA, IND, DSUR, INDAR, DRMP, RMP
• Supportsregistrations, label submissions and modifications: Contribute inthe clinical sections of the BLA/CTD, Briefing packages forregulatory meetings, PSP/PIP Clinical expertise, scientific dataevaluation and authorship:
• Act as a TA level expert/referent inthe field of autoimmunity.
• Evaluates relevant medical literatureand status from competitive products
• Support the planning of andparticipates to advisory board meetings
• Participate and authormanuscripts and abstracts
• Establish and maintains appropriatecollaborations with knowledge experts Experience
• Clinicaldevelopment in the field of autoimmune diseases
• Understanding ofpharmaceutical product development and life cycle management gainedthrough ~5-10 years of development and medical experience
• Excellent communication skills (verbal and written) forinteractions across functional areas and for interactions with keyregulatory agencies
• Ability to influence and negotiate to ensureoperational resources are available for continued clinical conduct
• Strategic leadership and understanding of the drug developmentvalue chain
• Excellent teaching skills, demonstrated ability toassist and train others
• Ability to work within a matrix model
• International/ intercultural working skills
• Open-minded to applynew digital solutions Minimum Level of any Required Qualifications
• Medical Doctor (MD): Experience in internal medicine and immunedriven diseases
• Fluency in written and spoken English Why ChooseUs?
• Bring the miracles of science to life alongside a supportive,future-focused team.
• Discover endless opportunities to grow yourtalent and drive your career, whether it’s through a promotion orlateral move, at home or internationally.
• Enjoy a thoughtful,well-crafted rewards package that recognizes your contribution andamplifies your impact.
• Take good care of yourself and yourfamily, with a wide range of health and wellbeing benefitsincluding high-quality healthcare, prevention and wellness programsand at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc.and its U.S. affiliates are Equal Opportunity and AffirmativeAction employers committed to a culturally diverse workforce. Allqualified applicants will receive consideration for employmentwithout regard to race; color; creed; religion; national origin;age; ancestry; nationality; marital, domestic partnership or civilunion 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

LI-Onsite vhd Allcompensation will be determined commensurate with demonstratedexperience. Employees may be eligible to participate in Companyemployee benefit programs, and additional benefits information canbe found here.