At a Glance
- Tasks: Lead global clinical programs and trials, ensuring high-quality data and regulatory compliance.
- Company: Join Novartis, a leader in reimagining medicine for better lives.
- Benefits: Enjoy competitive rewards, hybrid work options, and a commitment to diversity.
- Other info: Collaborate with top professionals and contribute to groundbreaking medical advancements.
- Why this job: Make a real impact in healthcare while advancing your career in a dynamic environment.
- Qualifications: Advanced degree in life sciences and extensive experience in clinical research required.
The predicted salary is between 72000 - 108000 £ per year.
The Clinical Development Director (CDD) is the clinical/scientific expert and if assigned the clinical development lead of a section of a global clinical program and/or trial. The CDD may be assigned to have a team leadership role for sections clinical programs and/or global clinical trials, depending on the size, nature and complexity.
Major accountabilities:
- Supports and if assigned leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Clinical deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
- Contributes and if assigned leads development and delivery of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities).
- Drives execution of the section of the clinical program in partnership with global line functions, in particular clinical operations, trial leaders and data management/analysis, and regional/country clinical development associates.
- Ensures ongoing clinical and scientific review of clinical trial data.
- Works in close collaboration with the data management and statistics teams to ensure proper data quality and analysis of clinical trial results.
- May be the Program or Function Manager of associates (e.g., CDD or associate CDD).
- Supports GPCH in assessing overall risk-benefit of the molecule for the assigned section of the clinical program, may be a (core) member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with the medical monitor, CDMD and Patient Safety.
- Member and if assigned may co-lead the Global Clinical Team (GCT), if there is a separate GCT for the assigned program section. Represents the section when assigned in Global Program Team (GPT) meetings, and as the section spokesperson in internal and external meetings/boards, as assigned.
- Supports the Clinical Development Head (CDH) by providing clinical/scientific input into IDP/CDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas.
Minimum requirements:
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred.
- ≥ 7 years of involvement in clinical research, global drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- ≥ 5 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry. Experience in late phase clinical development strongly preferred.
- Solid scientific writing skills.
- Experience with regulatory submissions (IND, NDA/BLA, CTA/MAA) preferred.
- Solid and advanced scientific acumen and ability to analyze and interpret scientific literature and data. Strong affinity with data, data quality and analysis.
- Preferred knowledge and/or experience of assigned therapeutic area.
- Demonstrated ability to establish strong scientific partnership with key internal and external stakeholders.
- ≥ 3 years people management experience required; this may include management in a matrix environment.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Clinical Development Director - Renal in London employer: Healthcare Businesswomen’s Association
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that fosters innovation and collaboration. With opportunities for professional growth and development in the heart of vibrant cities like London, Dublin, Barcelona, and Madrid, our Clinical Development Director role not only allows you to lead impactful clinical programmes but also to be part of a mission that reimagines medicine to improve lives. Join us and experience a workplace where your contributions are valued and your career can flourish.
Contact Details:
Healthcare Businesswomen’s Association Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Development Director - Renal in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. Tailor your responses to highlight how your experience aligns with their goals, especially in clinical development. Show them you’re not just another candidate, but the perfect fit!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. Focus on articulating your experience in clinical trials and data analysis clearly and concisely.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team and contributing to our mission in clinical development.
We think you need these skills to ace Clinical Development Director - Renal in London
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Clinical Development Director role. Highlight your relevant experience in clinical research and drug development, especially in Phases I through IV, to show us you’re the right fit.
Showcase Your Scientific Skills:We want to see your solid scientific writing skills shine through! Include examples of regulatory submissions or publications you've worked on, as this will demonstrate your expertise and understanding of the clinical landscape.
Highlight Leadership Experience:Since this role may involve team leadership, don’t forget to mention your people management experience. Share specific examples of how you've successfully led teams in a matrix environment to achieve clinical goals.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨Know Your Clinical Development Inside Out
Make sure you’re well-versed in the specifics of clinical development, especially in renal therapies. Brush up on your knowledge of Phases I through IV and be ready to discuss your experience with regulatory submissions. This will show that you’re not just familiar with the role but are genuinely passionate about it.
✨Showcase Your Leadership Skills
As a Clinical Development Director, you'll likely lead teams. Prepare examples of how you've successfully managed cross-functional teams in the past. Highlight your ability to foster collaboration and drive results, as this is crucial for the role.
✨Prepare for Data Discussions
Given the emphasis on data quality and analysis in the job description, be ready to discuss your experience with data management and interpretation. Bring specific examples of how you’ve ensured data integrity in previous trials, as this will demonstrate your scientific acumen.
✨Understand the Company’s Vision
Familiarise yourself with the company’s mission to reimagine medicine. Be prepared to articulate how your values align with theirs and how you can contribute to their goals. This shows that you’re not just looking for a job, but are genuinely interested in being part of their mission.
