Clinical Research Director - I&I
剑桥, 麻薩諸塞州Bridgewater, 新泽西州 Permanent 发布日期 Oct. 01, 2024
About the Job
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
The Clinical Research Director (CRD), Dupilumab, Immunology and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees.
As this role is on a large, complex, and highly successful team, the position requires a self-starting, creative, well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks. They must be able to comfortably operate independently and within a matrix team
Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.
Scientific and technical expertise
This position requires a strong scientific and clinical foundation in dermatology or respiratory or allergy as well as in all aspects of drug development. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.
Has and maintains deep scientific, technical and clinical expertise in respiratory/immunology field
Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
Maintains visibility within the I&I field to maintain credibility with internal and external stakeholders
Owns (in collaboration with Project Team), the “Abbreviated protocol” for individual studies, the clinical sections of BLA, CDP and the clinical sections of the IDP and is responsible Clinician for the implementation of clinical strategy
Influences the definition of the product value proposition 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
Clinical research planning and execution
An innovative and open-minded approach to problem solving is critical to arrive at the optimal solution for complex development challenges.
Contributes to the development of the clinical strategy and plan
Leads the development of the Abbreviated Protocol and Protocol development
Represents the clinical function on Clinical Study Teams and other teams as appropriate.
Ensure that all development activities are targeted towards timely achievement (e.g. Abbreviated Protocol and protocol before study start, committees management and centralized monitoring during study, and KRM & CSR preparation at study end)
Interacts with opinion leaders and external consultants
Regulatory responsibilities
Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
Ensures clinical data meets all necessary regulatory standards
Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities)
Participates in Advisory Committee preparation
Scientific data dissemination
Ensures timely submission and dissemination of clinical data
Supports the planning of advisory board meetings
Establishes and maintains appropriate collaborations with knowledge experts
In addition to the above activities the CRD must ensure that all activities of the Global Project Team (GPT) are conducted in compliance with current regulations, laws and guidance from FDA, EMEA, and CHMP, as well as with Sanofi’s policies and procedures.
Basic Qualifications
Medical Doctor is preferred. with dermatology/allergy/immunology/pulmonary clinical expertise preferred
More than 5 years of clinical or scientific experience, or more than >10 years industry, experience within I&I drug development
Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
Strong scientific and academic background with deep understanding of the disease
Good networking ability in cross-cultural environment
Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
Fluent in English (verbal and written communication)
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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.
追寻 发展。探索 菲凡。
进步需要我们每个人的参与——不论其背景、地域、或职业,我们都有一个共同的愿望:创造奇迹。你也可以成为其中的一员。我们不断追求变革,拥抱新思想,探索我们所能提供的一切机会。让我们一起追求进步。共同发现非凡。
在赛诺菲,不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同,我们为所有人提供平等的机会。
观看 “在赛诺菲的一天” ,并在官网 (sanofi.com) 上查看赛诺菲的多元化、公平与包容倡议!
在美国的职位
加入我们的美国团队。我们将为您提供专家指导和培训平台,从而帮助我们营造良好的企业文化。我们鼓励您以饱满的热情和充沛的精力投入到工作中,然后发挥自身能力推进药物和疫苗的研发,同时将研发到临床治疗的时间减半。
体验可能性
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我们的办公地点
我们的员工遍布60多个国家/地区。他们勠力同心,携手共创医疗健康领域的美好未来。无论您在哪里工作,我们的专家都会指导您推动职业发展,您也将能够运用先进的科学技术,取得意义非凡的重大突破。
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勇敢追梦,奔赴美好未来
想要改变自己的生活,乃至改变全球数百万人的生活,该怎么做?加入我们,开启职业新篇章,然后在我们的保驾护航中展翅高飞,并向优秀的人求教,为这份事业做出切实的贡献。
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您和我们相互依存,共同成长
我们精心打造薪酬体系,为您的身心健康、财务健康与社交健康提供全面保障。我们有着海纳百川的包容性团队文化,无论您在哪个岗位,都能展翅高飞。
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心怀梦想,成就一番事业
我们希望您以饱满的热情投入到自己的工作岗位中,给全球数百万人带来美好生活。您的职业发展道路由您自己来掌控。您只管制定目标,我们会提供充足的培训机会和支持,让您得偿所愿。
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我们的人与文化
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我们的故事
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为什么选择我们?
我们为您提供各种工具、支持和培训机会,帮助您实现自己的目标。我们也希望您充分发挥潜力,帮助我们实现目标:将新药研发到临床治疗的时间减半。
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