Clinical Research Director - I&I

TN United Kingdom; Cambridge; On-site; GBP 80,000 - 120,000; Full time

Job summary

An innovative global healthcare company is seeking a Clinical Research Director to lead clinical trials in the Immunology and Inflammation Therapeutic Area. This role involves developing and executing clinical protocols, engaging with regulatory agencies, and ensuring compliance with industry standards. The ideal candidate will have a strong background in clinical development, particularly in respiratory or immunology fields, and possess excellent analytical and interpersonal skills. Join a supportive team dedicated to improving lives through science and enjoy a comprehensive rewards package that promotes health and well-being.

Benefits

Health and Wellbeing Programs

Parental Leave

Comprehensive Rewards Package

Qualifications

• Medical Doctor preferred with expertise in immunology or pulmonary medicine.
• Over 5 years of clinical/scientific experience in drug development.

Responsibilities

• Develop and execute clinical trials for product registration.
• Lead protocol development and ensure compliance with regulatory standards.

Skills

Clinical Development

Regulatory Compliance

Analytical Skills

Interpersonal Skills

Networking

Education

Medical Doctor

PhD in Immunology

Job description

The job description is comprehensive but requires improvements in formatting and clarity. It currently uses HTML tags appropriately but contains some grammatical errors and inconsistent formatting that can be refined for better readability. The content is relevant and detailed, covering responsibilities, qualifications, and company benefits. Minor revisions will enhance professionalism and flow.

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Clinical Research Director - I&I, Cambridge

Client: Sanofi

Location: Cambridge, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: f66d6018911f

Job Views: 14

Posted: 26.04.2025

Expiry Date: 10.06.2025

Job Description:

About the Job

We are an innovative global healthcare company with a singular purpose: to pursue the miracles of science to improve people's lives. We are a company where you can flourish and grow your career, with countless opportunities to explore, connect with people, and push the boundaries of what you thought was possible. Ready to get started?

The Clinical Research Director (CRD), Dupilumab, Immunology and Inflammation Therapeutic Area, is responsible for developing, executing, and reporting on clinical trials supporting product registration. The CRD reports directly to the Clinical Lead overseeing the clinical strategy. Responsibilities include developing abbreviated and full clinical protocols, reviewing protocols, study reports, labeling, and supporting interactions with regulatory agencies and ethics committees.

This role requires a self-starting, creative, well-organized, strategic, resourceful individual with excellent emotional intelligence, self-motivation, strong analytical skills, and the ability to manage multiple operational tasks independently and within a matrix team.

Core Responsibilities

Scientific and Technical Expertise

• Maintain deep scientific, technical, and clinical expertise in respiratory/immunology fields.
• Proven track record in clinical development, with Phase 3 experience being advantageous.
• Stay updated with pre-clinical, clinical pharmacology, and relevant data, including antibody knowledge.
• Critically evaluate medical literature and understand data from competitive products.
• Own and develop clinical protocols in collaboration with project teams.
• Influence product value proposition and research strategies based on clinical insights.

Clinical Research Planning and Execution

• Contribute to clinical strategy and planning.
• Lead development of protocols and abbreviated protocols.
• Represent the clinical function in study teams and ensure timely achievement of development activities.
• Engage with opinion leaders and external consultants.

Regulatory Responsibilities

• Represent the division at regulatory meetings as the medical spokesperson.
• Ensure clinical data compliance with regulatory standards.
• Support registration activities, including label submissions and modifications.
• Participate in advisory board preparations and maintain collaborations with knowledge experts.

Qualifications

• Medical Doctor preferred, with expertise in dermatology, allergy, immunology, or pulmonary medicine.
• Over 5 years of clinical/scientific experience, or over 10 years in industry within I&I drug development.
• Proven scientific achievement through publications or successful clinical studies/submissions.
• Strong networking, interpersonal, communication, and negotiation skills.
• Fluent in English (verbal and written).

Why Choose Us?

Join us to bring the miracles of science to life alongside a supportive, future-focused team. Discover opportunities for growth, enjoy a comprehensive rewards package, and benefit from health and wellbeing programs, including parental leave. We are committed to diversity and equal opportunity.

Our Commitment

At Sanofi, we value diversity and provide equal opportunities to all. Join us in making a difference.