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- Tasks: Lead strategic planning and operational support for clinical development excellence.
- Company: Join Novartis, a global leader in healthcare innovation.
- Benefits: Enjoy hybrid working, competitive salary, and professional development opportunities.
- Why this job: Make a real impact on clinical programs and collaborate with top experts in the field.
- Qualifications: MD or PhD required, with 10+ years in pharmaceutical industry experience.
- Other info: Fluent English is essential; oncology expertise is a plus.
The predicted salary is between 72000 - 108000 £ per year.
The Head Protocol & Clinical Program Excellence will provide strategic planning and operational execution support to the Head CD Program Scientific Excellence to deliver on the CD program excellence goals aligned with the overall CD strategy and vision. This role must have keen and broad clinical science insight and experience, to positively impact Novartis' protocols and CDPs, the fundamental units of Development's scientific work.
This role will oversee the operational activities of CD Central Integrated Scientific Review Committee (C-ISRC) and work closely with Head CD Program Scientific Excellence, CDHs, GPCHs, as well as cross-functional partner functions as needed. This role will provide operational support to leverage the latest industry trends, scientific rigor and apply best practices consistently across the CD teams to ensure delivery of high-quality clinical programs. This role is based in the UK / London and in a hybrid working approach.
Minimum Requirements:- Provides scientific and operational support to the Central Integrated Scientific Review Committee (C-ISRC), ensuring a thorough review of Clinical Development Plans (CDPs) and key clinical documents (Study protocols, DMC charters, etc.), to maintain high levels of quality and consistency across the therapeutic areas.
- Heads the ISRC Office and is the line function manager for the Director Protocol & Clinical Program Excellence and ISRC Leads in charge of managing ISRC activities. This includes organization of priority topics, key outcomes and actions and regulatory feedback, improvements to C-ISRC strategic advice through establishing and reporting metrics and their review process.
- Working with Head CD Program Scientific Excellence and CDHs, supports and guides GPCHs for the design, implementation, and execution of clinical development program(s) to support decision milestones, regulatory requirements and market access.
- Supports and acts as delegate to the Head CD Program Scientific Excellence in activities like interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS stakeholders as needed.
- May serve as senior functional expert for individual clinical projects, e.g. assess results of Phase I-III investigations in preparation for new-drug application.
- Provides clinical input to evaluate products for in licensing/out licensing, participates in business development processes as needed.
- Supports in driving scenario development for Clinical Development to support decision analysis and portfolio decisions, as needed.
- Supports and executes plans on strategic enhancement and simplification of the Novartis clinical development approach (CDP, clinical trial designs, protocol and its review) to improve speed and outcome success of clinical programs.
- Engages the GPCH and the broader CD community around clinical learnings across therapeutic areas. Supports the CD talent step-up strategy. Supports strategic directions for professional CD capability building.
- Supports the Head CD Program Scientific Excellence to build cross-function collaborations and initiatives leading to a step-wised transition to the futuristic digital clinical trial era.
- Seamless delivery of CD program excellence initiatives and projects.
- Seamless management of regular C-ISRC meeting; documentation of the meeting minutes and follow up of action items.
- Extensive collaboration and effective partnerships with the relevant stakeholders.
- MD, PhD with extensive clinical development expertise, MD/PhD required.
- Fluent oral and written English.
- 10+ years pharmaceutical industry experience; with a focus on medical, clinical development, regulatory and related work. Preferred versatile talents with varied experience beyond clinical.
- People leadership experience preferred.
- Broad external connections and strong bonds with KOLs.
- Outstanding verbal and written communications.
- Strong evidence of strategic thinking.
- Strong skills at influencing without formal authority.
- Proven track record in working across a matrix organization and demonstrating expert skills in building partnerships.
- Oncology clinical development expertise.
- Budget Management
- Clinical Trials
- Coaching
- Compliance
- Cross-Functional Teams
- Leadership
- People Management
- Risk Management
- Risk Monitoring
- Strategy
Head Protocol and Clinical Program Excellence employer: Healthcare Businesswomen's Association
Contact Detail:
Healthcare Businesswomen's Association Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head Protocol and Clinical Program Excellence
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those with experience in clinical development and regulatory affairs. Attend relevant conferences or webinars to meet potential colleagues and learn about the latest trends in clinical program excellence.
✨Tip Number 2
Familiarise yourself with Novartis' current clinical development strategies and recent projects. Understanding their approach will help you align your discussions and demonstrate how your experience can contribute to their goals during interviews.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led cross-functional teams or managed complex clinical projects. Highlight your ability to influence stakeholders and drive strategic initiatives without formal authority.
✨Tip Number 4
Stay updated on the latest advancements in oncology clinical development if you have that expertise. Being knowledgeable about current challenges and innovations in this area can set you apart as a candidate who is ready to contribute immediately.
We think you need these skills to ace Head Protocol and Clinical Program Excellence
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical development, particularly in roles that demonstrate your strategic thinking and leadership skills. Use specific examples that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that clearly articulates your passion for clinical program excellence and how your background aligns with the goals of Novartis. Mention any specific experiences that showcase your ability to manage cross-functional teams and drive strategic initiatives.
Highlight Key Achievements: In both your CV and cover letter, emphasise key achievements from your previous roles, especially those related to clinical trials, regulatory interactions, and stakeholder management. Quantify your successes where possible to demonstrate impact.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents to eliminate any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for the role.
How to prepare for a job interview at Healthcare Businesswomen's Association
✨Showcase Your Clinical Expertise
Make sure to highlight your extensive clinical development experience during the interview. Discuss specific projects you've worked on, particularly those that align with the role's focus on clinical protocols and development plans.
✨Demonstrate Strategic Thinking
Prepare examples that showcase your ability to think strategically. Discuss how you've contributed to the strategic direction of previous projects or initiatives, especially in relation to clinical programme excellence.
✨Highlight Leadership Skills
Since this role involves managing teams and leading initiatives, be ready to discuss your leadership style and experiences. Share instances where you've successfully influenced others and built effective partnerships across different functions.
✨Familiarise Yourself with Industry Trends
Stay updated on the latest trends in clinical development and regulatory requirements. Be prepared to discuss how these trends can impact the role and how you would leverage them to enhance clinical programmes at Novartis.
