Clinical Research Director, I&I (Allergy/Dermatology)
Clinical Research Director, I&I (Allergy/Dermatology)
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Clinical Research Director - allergy-immunology-dermatology
The Clinical Research Director (CRD) is noted as the primary clinical expert for programs. The role requires a well-organized, strategic and operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.
Key responsibilities include:
Participate/support clinical program lead in the clinical development plan strategies:
- Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams
- Raise study issues to the clinical lead
- Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators
- Evaluates relevant medical literature and status from competitive products
Lead, Support and oversee the execution of clinical development and studies activities
- Review and validate the final protocol and protocol amendments
- Review the ICF WSI and TDF
- Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
- Lead the study specific committees (IDMC, steering com, adjudication …) with operational support
- Co-Develop the SAP in collaboration with bio stats
- Responsible for key results preparation
- Develop the clinical study report
- Take on as necessary the Associate CRD role:
- Develop the abbreviated protocol
- Develop the final protocol and protocol amendments
- Medical support to clinical operation team during the clinical feasibility
- Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan
- Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review
- Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
- Participate in the elaboration of training material and presentations at the investigator meetings
- Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with operational support, bio stat and GSO
- Answer to medical questions raised by EC/IRBs, sites
- Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
- Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:
- feasibility managers for feasibility preparation and validation of feasibility results
- Medical Writers to develop, review and finalize WSIs, study protocols and reports
- Clinical Scientists, Medical review team and Coding
- Pharmacovigilance (GSO, CME)
- CTOMs, Biostatisticians
- CSU medical advisors for the best knowledge of the study, compound, protocol
- TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs
- Regulatory affairs
- Collaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to the global project head and clinical lead
- Provide operational expertise to project clinical sub team, as needed
Responsibilities related to regulatory and safety documents and meetings:
- Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
- Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
- Ensures clinical data meets all necessary regulatory standards
- Participates in Advisory Committee preparation
Scientific Data evaluation and authorship: Participate and author manuscripts and abstracts Support the planning of advisory board meetings Establish and maintains appropriate collaborations with knowledge experts Contribute on an ad hoc basis 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
- Robust Scientific and medical/clinical expertise
- Expertise in clinical development and methodology of clinical studies
- Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
- Demonstrated capability to challenge decision and status quo with a risk-management approach
- Ability to negotiate to ensure operational resources are available for continued clinical conduct
- Fluency in written and spoken English
- Very good teaching skills, demonstrated ability to assist and train others
- Ability to work within a matrix model
- International/ intercultural working skills
- Open-minded to apply new digital solutions
Minimum Level of any Required Qualifications:
- Medical Doctor (MD): trained in allergy and/or immunology and/or dermatology
- English fluent (spoken and written)
- Experience in clinical trials (industry or academia as PI)
- Computer skills
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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