Clinical Research Director, I&I
The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in rheumatological or osteoarthritic diseases, incorporate new methodologies, and pro-actively progress study execution.
MAIN RESPONSIBILITIES
Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
Advance the CDP through internal management review
Leads a clinical sub team to design clinical studies and to create an abbreviated and full clinical study protocol
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation)
Contribute to data review, interpretation and publication of clinical study results
Represent Clinical Development at Health Authorities and incorporating advise into development strategy.
Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program
Align company position on clinical strategy with partner in alliance projects
Translate biology into clinic in close collaboration with research and translational medicine
Evaluate clinical aspects of business development opportunities as needed
Apply high ethical standards and work with integrity
PROFILE
Scientific and Technical Expertise
This position requires a strong scientific and clinical foundation rheumatology or osteoarthritis. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.
Be experienced in advancing assets from discovery into clinical development
Have experience in novel approaches in translational medicine
Have and maintain deep scientific, technical and clinical knowledge in arthritic diseases
Demonstrated problem solving skills
Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome
Understand novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods
Understand the competitive environment
Have established connections within the medical field of their expertise
Have a credible publication record
Basic Qualifications
Medical Doctor. Should be board certified or equivalent in dermatology or allergy / immunology
Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent
More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology
Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred
Knowledge of drug development preferred
Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment
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.Estimated Salary: $20 to $28 per hour based on qualifications.
MAIN RESPONSIBILITIES
Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
Advance the CDP through internal management review
Leads a clinical sub team to design clinical studies and to create an abbreviated and full clinical study protocol
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation)
Contribute to data review, interpretation and publication of clinical study results
Represent Clinical Development at Health Authorities and incorporating advise into development strategy.
Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program
Align company position on clinical strategy with partner in alliance projects
Translate biology into clinic in close collaboration with research and translational medicine
Evaluate clinical aspects of business development opportunities as needed
Apply high ethical standards and work with integrity
PROFILE
Scientific and Technical Expertise
This position requires a strong scientific and clinical foundation rheumatology or osteoarthritis. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.
Be experienced in advancing assets from discovery into clinical development
Have experience in novel approaches in translational medicine
Have and maintain deep scientific, technical and clinical knowledge in arthritic diseases
Demonstrated problem solving skills
Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome
Understand novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods
Understand the competitive environment
Have established connections within the medical field of their expertise
Have a credible publication record
Basic Qualifications
Medical Doctor. Should be board certified or equivalent in dermatology or allergy / immunology
Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent
More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology
Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred
Knowledge of drug development preferred
Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment
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.Estimated Salary: $20 to $28 per hour based on qualifications.
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