At a Glance
- Tasks: Lead clinical development for global trials and ensure high-quality data analysis.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Enjoy competitive rewards, inclusive culture, and opportunities for professional growth.
- Other info: Hybrid work model with a commitment to diversity and inclusion.
- Why this job: Make a real impact in clinical research and improve patient outcomes globally.
- Qualifications: Advanced degree in life sciences and 5+ years in clinical research required.
The predicted salary is between 80000 - 100000 £ 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 (e.g., an indication, a new formulation, or a specific development phase) or a large, complex trial, under the leadership of the GPCH. The CDD may also assume a team‑leadership role for sections of clinical programs and/or global clinical trials, depending on the size, nature, and complexity of the program.
About The Role
Office Location: London, UK or Dublin, Ireland
Hybrid: 12 days per month on-site
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 teams, 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.
- Might 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 serve as 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.
- Serves as a member, and if assigned may (co‑)lead, the Global Clinical Team (GCT) when there is a separate GCT for the assigned program section.
- Represents the section when assigned in Global Program Team (GPT) meetings, and acts 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 to the development of disease clinical standards for new disease areas.
- May take on other TA responsibilities as directed by the CDH.
Minimum Requirements
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD or PhD strongly preferred.
- Proven experience working in clinical research/global drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- Minimum 5 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, execution, reporting and publishing) in a global/matrix environment in the 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.
Final job title (Clinical Development Director, Level 6) and associated responsibilities will be commensurate with the successful candidate’s level of expertise.
Commitment To Diversity And Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams that are representative of the patients and communities we serve.
Benefits and Rewards
Find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Clinical Development Director - Renal employer: Novartis UK
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the heart of London or Dublin. Our commitment to employee growth is reflected in our comprehensive benefits package and opportunities for professional development, ensuring that our team members thrive while making a meaningful impact in the field of clinical research. Join us to be part of a diverse and inclusive environment where your expertise will contribute to advancing healthcare solutions for patients worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Development Director - Renal
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can land you that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practising common interview questions and tailoring your answers to highlight your experience in clinical development. Show them you’re the perfect fit for their team!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email expressing your appreciation for the opportunity. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search. Let’s get you that Clinical Development Director position!
We think you need these skills to ace Clinical Development Director - Renal
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 any specific projects that align with the job description. We want to see how your background fits perfectly with what we're looking for!
Showcase Your Scientific Skills:Since this role requires solid scientific writing skills, don’t shy away from showcasing your best work. Include examples of regulatory submissions or publications you've contributed to. This is your chance to shine and show us your expertise in the field!
Be Clear and Concise:When writing your application, clarity is key! Use straightforward language and avoid jargon where possible. We appreciate a well-structured application that gets straight to the point while still reflecting your personality.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you're keen on joining our team at StudySmarter!
How to prepare for a job interview at Novartis UK
✨Know Your Clinical Stuff
Make sure you brush up on the latest trends and developments in renal clinical research. Be prepared to discuss your experience with Phases I through IV of clinical trials, as well as any specific therapeutic areas you've worked in. This will show that you're not just familiar with the basics but are also a true expert in your field.
✨Showcase Your Leadership Skills
As a Clinical Development Director, you'll likely be leading teams and projects. Prepare examples of how you've successfully led clinical programs or trials in the past. Highlight your ability to collaborate with cross-functional teams and how you've driven execution in complex environments.
✨Be Ready for Regulatory Talk
Since regulatory submissions are a big part of this role, make sure you can discuss your experience with documents like INDs, NDAs, and CTAs. Familiarise yourself with the regulatory landscape and be ready to explain how you've contributed to successful submissions in your previous roles.
✨Prepare Questions for Them
Interviews are a two-way street! Think of insightful questions to ask about their clinical development strategies, team dynamics, and how they approach data quality and analysis. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
