R&D - Clinical Research Director - SH/BJ at Sanofi Aventis US LLC

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

18 Jan, 26

Salary

0.0

Posted On

20 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Medical Expertise, Regulatory Compliance, Clinical Development, Project Management, Analytical Skills, Communication Skills, Team Leadership, Risk Management, Data Evaluation, Pharmaceutical Development, Biostatistics, Feasibility Assessment, Training Skills, Cross-Cultural Experience, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

JOB DESCRIPTION Clinical Research Director 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. The role of the CRD is to: Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps Take on as necessary the Associate CRD role: Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report) Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment) Contribute to the Extended synopsis and Protocol for their project 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 Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data undefined Key responsibilities include: 1. Leading the clinical development plan strategies: o Responsible for the clinical development plans and clinical sections of integrated development plans (IDP) 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 or project-level issues to the project head o Contribute in 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 o Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators o Evaluates relevant medical literature and status from competitive products 2. Lead, Support and oversee the execution of clinical development and studies activities o Review and validate the final protocol and protocol amendments o Review the ICF WSI and TDF o 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) o Lead the study specific committees (IDMC, steering com, adjudication …) with operational support o Co-Develop the SAP in collaboration with bio stats o Responsible for key results preparation o Develop the clinical study report Raise study or project-level issues to the project head § 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 Raise study or project-level issues to the project head § 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 CROs 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 3. Responsibilities related to regulatory and safety documents and meetings: o Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP o Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP o Ensures clinical data meets all necessary regulatory standards o Participates in Advisory Committee preparation 4. Scientific Data evaluation and authorship: o Participate and author manuscripts and abstracts o Support the planning of advisory board meetings o Establish and maintains appropriate collaborations with knowledge experts o 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 Experience o Understanding of pharmaceutical product development and life cycle management gained through ~6 years of development and medical experience o Very good Scientific and medical/clinical expertise o Very good expertise in clinical development and methodology of clinical studies o Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies o Demonstrated capability to challenge decision and status quo with a risk-management approach o Ability to negotiate to ensure operational resources are available for continued clinical conduct o Fluency in written and spoken English o Very good teaching skills, demonstrated ability to assist and train others o Ability to work within a matrix model o International/ intercultural working skills o Open-minded to apply new digital solutions Minimum Level of any Required Qualifications: At least 6 years of experience in Clinical Drug Development for a large pharmaceutical or a biopharmaceutical company Strong medical background particularly within the therapeutic domain, background in Hametology and Neurology will be perferred Excellent understanding of the drug development processes and the regulatory framework for clinical trials. Strong team player with Experience in leading multiple, diverse clinical development programs. Strong verbal and written communication skills, fluency in English, ability to work transversally Ability to interpret clinical data accurately Good understanding of biostatistics, pharmacokinetics, regulatory environment (China and Worldwide) Ability to analyze and summarize scientific and clinical data and develop recommendations that affect the conduct of studies and the content of regulatory submissions. Cross-cultural experience in Clinical Drug Development Quality and Compliance oriented Ability to drive change and innovation Ability to work independently and think strategically Result-oriented and decision-making mindset Behavioral excellence Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Clinical Research Director is responsible for leading clinical development plans and ensuring the execution of clinical studies in compliance with regulations. This role involves collaboration with various stakeholders to resolve project-related issues and provide medical expertise throughout the clinical trial process.