CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Clinical Research Director - I&I

Company: Sanofi
Location: Cambridge
Posted on: February 17, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the--Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our--colleagues will explain how these tools will be used throughout the recruitment process and will be on hand to answer any questions you might have. From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner. Do you have what it takes for a successful career with Sanofi? -- The Clinical Research Director (CRD) Dupilumab, Immunology and Inflammation Therapeutic Area, is responsible for contributing to the creation and execution of the clinical development strategy for Dupilumab in different indications. The CRD is expected to contribute to the growth of Dupilumab by both being a driver of clinical and scientific knowledge and advancing operational capabilities by challenging "the status quo". -- Based upon an in-depth scientific understanding and extensive clinical experience, the CRD is responsible for: o Drafting the abbreviated protocol of studies that he/she will be responsible for, and lead the creation of the clinical development plans (CDP), the clinical sections of integrated development plans (IDP), as well as overseeing the execution of such plans by the respective operational units in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs). He/she will also represent the project in relevant teams and the protocol review committee and review and comment the Investigator's brochure. o Lead and write clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP o Assisted by related Sanofi Genzyme functions (e.g. clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials. o Defends the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable. The CRD may provide input into strategies to increase understanding of the mechanism of action of the drug including but not limited to the identification of biomarkers. On an ad hoc basis the CRD will be requested to contribute expertise to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams. Scientific and Technical Expertise: -- This position requires a strong scientific and clinical foundation in dermatology or respiratory or allergy--as well as in all aspects of drug development. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. -- Has and maintains deep scientific, technical and clinical expertise in dermatology or respiratory or allergy and related areas -- Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest -- Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products -- Maintains visibility within the Immunology & Inflammation Therapeutic Area in general and more specifically in dermatology or respiratory or allergy to maintain credibility with internal and external stakeholders -- Ensure that all development activities are proactively planned and targeted towards timely achievement -- Interacts with opinion leaders and consultants. -- Owns (in collaboration with Project Team), the "Abbreviated protocol" for individual studies, the clinical sections of BLA, CDP and the clinical sections of the IDP and is responsible Clinician for the implementation of clinical strategy -- Influences the definition of the product value proposition and market access strategy (in collaboration with respective functions)and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects Complex problem solving -- As CDPs, BLAs/CTDs are sophisticated documents that require the ability to integrate highly complex scientific, medical and operational information, strong scientific, medical and analytical skills are required. -- An innovative and open-minded approach to problem solving is critical to arrive at the optimal solution for complex development challenges.-- Regulatory Responsibilities: -- Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project -- Responsible for BLA clinical sections -- Ensures clinical data meets all necessary regulatory standards -- Supports registrations, label submissions and modifications -- Participates in Advisory Committee preparation Scientific Data Dissemination: -- Ensures timely submission and dissemination of clinical data -- Participate and author manuscripts and abstracts -- Supports the planning of advisory board meetings -- Establishes and maintains appropriate collaborations with knowledge experts -- In addition to the above activities the CRD must ensure that his/her contributions to the Global Project Team are conducted in compliance with current regulations, laws and guidance from FDA, EMA, and CHMP, as well as with Sanofi's policies and procedures. Basic Qualifications: -- Medical Doctor, PhD desirable. Should be board certified or eligible in dermatology, or respiratory, or allergy or Immunology, or gastro-enterology, OR -- Must have completed education and training at a medical school -- More than 5 years of clinical or scientific, or more than > 10 years industry, experience within I&I or dermatology or respiratory (pulmonology, rhinology, ENT), gastro-enterology drug development -- Strong scientific and academic background with deep understanding of the disease -- Clinical research experience in dermatology, allergology, respiratory, gastro-enterology drug development preferred -- Good networking ability in cross-cultural environment -- Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization -- Performance oriented with ability to work along agreed timelines and a focus on strategy and execution -- Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills -- Fluent in English (verbal and written communication) Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Join our Talent Network and get Sanofi communications delivered to your inbox. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Sanofi.

Keywords: Sanofi, Cambridge , Clinical Research Director - I&I, Healthcare , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Registered Nurse (Part Time)
Description: Harris Hill Center is excited to offer New RN wages up to 48.75hr wages based on years of experience and selection of modified compensation Walk-in Wednesdays On-site Interviews 10am-4pm every Wednesday (more...)
Company: Harris Hill Center - Genesis HealthCare
Location: Concord
Posted on: 02/26/2021

Licensed Nursing Assistant (LNA)
Description: All assignments provide you with: Personal Recruiter and Support Staff
Company: Protocol Agency
Location: Concord
Posted on: 02/26/2021

Licensed Therapist for Online Counseling
Description: Private practice with no doors and no overhead. Join the world's largest online counseling platform. We provide the marketing, the technology, and the additional income. You provide the professionalism, (more...)
Company: BetterHelp
Location: Concord
Posted on: 02/26/2021


Travel RN-Telemetry - South Weymouth, MA (RN #)
Description: ul li RNnetwork has an excellent travel opportunity for a provider experienced in the following specialty: RN-Telemetry. This opportunity will be available
Company: RNnetwork
Location: Weymouth
Posted on: 02/26/2021

Medical Intensive Care - Travel MICU RN
Description: Medical Intensive Care Nurse MICU Nationwide Travel Nurse Assignments Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are (more...)
Company: HealthCare Traveler Jobs
Location: Concord
Posted on: 02/26/2021

Physician Assistant Cardiac Surgery in NH - Experienced CVT PA needed
Description: A Hospital system in Southern New Hampshire is looking for a CVT Physician Assistant with vein harvesting experience to join their team. This is a Monday - Friday permanent position offering a 4 day work (more...)
Company: CompHealth
Location: Concord
Posted on: 02/26/2021

Licensed Health Insurance Agent - Sell Anthem, Teledoc, UHC, and more
Description: Job Description This role requires the candidate to currently have a Residential
Company: ASSURANCE Independent Agents
Location: East Providence
Posted on: 02/26/2021

Progressive Care Unit RN - Travel PCU Nurse
Description: Progressive Care Unit RN - Nationwide Travel PCU Nurse Assignments Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking (more...)
Company: HealthCare Traveler Jobs
Location: Concord
Posted on: 02/26/2021

RN, Critical Care Specialties - HealthCare Traveler
Description: Critical Need for All Hospital Based RN SpecialtiesTravel Registered Nurse Jobs Assignments br Looking for an RN travel assignment You are in the right place, the HCEN Network of staffing agencies (more...)
Company: HealthCare Traveler Jobs
Location: East Providence
Posted on: 02/26/2021

Travel Registered Nurse RN Skilled Nursing
Description: Skilled Nurses works with complex wound dressings,-rehabilitation, tube feedings or rapidly changing health status.-A
Company: One Staff Medical
Location: Concord
Posted on: 02/26/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds