Senior Clinical Research Director, I&I
Senior Clinical Research Director, I&I
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The Senior Clinical Research Director (Sr CRD) is the primary clinical lead for a clinical development program, reporting into the Global Project Head (GPH), and managing a team of Clinical Research Directors and Clinical scientists.
The role requires a well-organized, experienced, strategic focused and resourceful individual with interpersonal skills, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.
The anti-TL1A program is a co-development with TEVA, with a primary focus in inflammatory bowel diseases and with planned indication expansion in immune driven and fibrotic diseases.
The role of the Senior CRD is to:
Lead the clinical development plan strategies and implementation
Lead/Act as a mentor for other CRDs and Clinical Scientists on a same project/TA
Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). Within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams.
Lead clinical activities:
Provide clinical expertise
Support study related clinical activities, e.g. protocol development, pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment
Oversee and 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
Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
Coordinate with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps
Key responsibilities include:
Clinical development plan strategies:
Clinical strategy: Develop and assess clinical scenarios in alignment with Global Project Head
Internal Governance: Preparation of documents and presentations for internal governance meetings
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
Contribute to the definition of the product value proposition (TVP), TPP 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
Engage and collaborate with internal and external partners, regulators, and experts
Execution of clinical development and studies activities
Lead 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 the final protocol, protocol amendments and study supporting documents
Co-Develop the SAP in collaboration with bio stats
Responsible for key results preparation and clinical study report
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)
Medical support to clinical operation team during the clinical feasibility
Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with clinical scientist, 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
Contribution to regulatory and safety documents and meetings: Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project. Oversee and is accountable for clinical input in key regulatory documents: Review and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP. Supports registrations, label submissions and modifications: Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
Clinical expertise, scientific data evaluation and authorship:
Act as a TA level expert/referent in the field of inflammatory bowel diseases.
Evaluates relevant medical literature and status from competitive products
Support the planning of and participates to advisory board meetings
Participate and author manuscripts and abstracts
Establish and maintains appropriate collaborations with knowledge experts
Clinical development in the field of immune driven disease and ideally in inflammatory bowel disease
Understanding of pharmaceutical product development and life cycle management gained through ~5 years of development and medical experience
Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
Ability to influence and negotiate to ensure operational resources are available for continued clinical conduct
Strategic leadership and understanding of the drug development value chain
Excellent 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): Gastroenterologist and/or experience in internal medicine and immune driven diseases
Fluency in written and spoken English
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.
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