At a Glance
- Tasks: Lead global clinical programs and trials, driving innovative research in healthcare.
- Company: Join Novartis, a leader in reimagining medicine with a commitment to diversity.
- Benefits: Competitive salary, performance bonuses, flexible working, and generous parental leave.
- Other info: Dynamic environment with opportunities for professional growth and collaboration.
- Why this job: Make a real impact in clinical development and shape the future of healthcare.
- Qualifications: Advanced degree in life sciences and proven experience in clinical research required.
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:
- 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.
- 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.
Work Experience:
- 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. 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.
Benefits & Rewards:
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: 83,510.00 - 119,300.00 - 155,090.00 GBP Annual. The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. Long-term equity awards granted at group level may also be part of your package.
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here.
Skills Desired: Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teamwork, Lifesciences (Inactive), People Management, Risk Management, Risk Monitoring.
Location: London (The Westworks)
Type: Full time
Director Of Research Development in London employer: Novartis
At Novartis, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our hybrid work model allows for flexibility while providing ample opportunities for professional growth and development in the pharmaceutical industry. With a commitment to enhancing customer experiences for healthcare professionals and patients alike, joining our team means contributing to meaningful work that makes a difference in people's lives.
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We think this is how you could land Director Of Research Development in London
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We think you need these skills to ace Director Of Research Development in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Novartis!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Novartis that you're not just a fit for the job but also a safety-conscious candidate!
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