Clinical Research Director, Neurology
Cambridge, Massachusetts, Bridgewater, New Jersey
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Key role on the Neurology clinical development strategy team
Support global project team in program strategy, target product profile, and target value profile, integrated development plan (IDP)/clinical development plan (CDP) in line with the program objectives, commercial strategy and regulatory needs for neurology assets
In collaboration with clinical development team, prepare presentations to obtain internal governance endorsement of the clinical strategic plan
Support design and execution of multiple clinical studies defined within development plan
Provide support in preparation and authoring of regulatory submissions, briefing packages, labelling documents, and scientific meetings, such as advisory boards, consultant meetings, and investigator meetings.
Support the preparation of key clinical documents for clinical trials (investigator brochure, study protocols, informed consent, benefit risk assessments)
Build and maintain a strong network of internal and external collaborations with relevant experts, key opinion leaders, investigators
Maintain deep scientific, technical, and clinical expertise in neurology
Critically read and evaluate relevant literature with deep understanding of the data and status from competitive products, and provide clinical landscape and benchmark updates to Project team
Support and serve as delegate for Project Head to develop, execute, and provide oversight of clinical development plan, strategy for regulatory approval and plans for interactions with health authorities
Perform clinical review and analysis of data listings, patient profiles, and essential study data within statistical reports and partner with Data Management in generating relevant queries
Participate in CRF design, review CRF design and completion instructions
Support CRD and Study Team with study start-up, site opening, study enrolment
Support Therapeutic Area leadership with cross-programs strategy, and with evaluation of pre-clinical or clinical neurology drug opportunities, as needed
Scientific and Educational background
Advanced degree such as PhD, PharmD, or MD, in a Life Science or Health Science related field. MPH or Biomedical Science master combined with extensive drug development experience may be considered.
5+ years of industry experience, including both research and clinical development. Academic clinical research may also be considered.
Proficient in clinical literatures and critical interpretation of clinical study results
Experience with supporting preparation and execution of Phase I/II/III clinical trials
Demonstrated understanding of the drug development process ; prior experience with regulatory Authority interactions for clinical trials is a plus
Strong scientific and academic background in neurology or neuroscience, additional expertise in neuroimmunology, neuroimaging or other related specialty area a plus
Knowledge of translational medicine and biomarkers
Strategic thinking in combination with understanding of up-to-date therapeutic landscape
Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance
Experience with innovative and novel methodologies for clinical trials a plus (adaptive designs, digital, real world evidence, patient centered approaches)
Professional and behavioral competencies
Experience in successful collaboration with and leading cross-functional global teams of interdisciplinary professionals
Ability to integrate complex data and scientific concepts into clear written documents and presentation materials.
Ability to interact and effectively communicate with all levels of personnel within the organization and with clients and collaborators (i.e., investigators, vendors and CROs)
Proven ability to manage projects/team of significant scope and complexity, while meeting all deliverables and timelines
Ability to drive and coordinate activities including prioritizing capacity, issue identification and resolution
Ability to motivate the team towards advancing the project according to milestones and delivering good quality data
Ability to work, network and communicate with a global product team, in an international matrix organization and across companies in co- development projects
Open, transparent, collaborative working style
Good leadership, interpersonal, communication, and presentation skills (oral and written)
Good problem-solving, conflict-resolution and decision-making skills
Strategic thinking, analytic and synthetic capacity
Team spirit and flexibility with strong motivation to bring important medical advances to patients
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
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.
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