Head Protocol and Clinical Program Excellence

Novartis; England; Hybrid; GBP 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Head of Protocol & Clinical Program Excellence to lead strategic planning and operational execution in clinical development. This pivotal role requires extensive clinical science insight to enhance the quality of clinical programs. You will oversee the Central Integrated Scientific Review Committee, guide clinical development programs, and foster collaborations across functions. The position offers a hybrid working approach, allowing you to balance professional and personal commitments while making a significant impact in the pharmaceutical industry.

Qualifications

• MD or PhD with extensive clinical development expertise required.
• Over 10 years of experience in pharmaceutical industry preferred.

Responsibilities

• Provide scientific and operational support to the C-ISRC.
• Lead strategic initiatives to enhance Novartis's clinical development approach.
• Engage with GPCHs to share learnings and support talent development.

Skills

Clinical Development Expertise

Strategic Thinking

Communication Skills

Leadership Experience

Influencing Skills

Regulatory Knowledge

Oncology Expertise

Education

MD or PhD

Job description

Summary

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 requires broad clinical science insight and experience to positively impact Novartis’ protocols and CDPs, the fundamental units of Development’s scientific work.

The role will oversee the operational activities of the CD Central Integrated Scientific Review Committee (C-ISRC) and work closely with the Head of CD Program Scientific Excellence, CDHs, GPCHs, and cross-functional partners as needed. It will provide operational support to leverage industry trends, scientific rigor, and best practices across the CD teams to ensure high-quality clinical program delivery.

This position is based in the UK / London with a hybrid working approach.

About the Role

Minimum Requirements:

1. Provide scientific and operational support to the Central Integrated Scientific Review Committee (C-ISRC), ensuring thorough review of Clinical Development Plans (CDPs) and key clinical documents (study protocols, DMC charters, etc.), maintaining high quality and consistency across therapeutic areas.
2. Head the ISRC Office and serve as the line manager for the Director of Protocol & Clinical Program Excellence and ISRC Leads, managing ISRC activities, prioritization, outcomes, and regulatory feedback, including establishing and reporting metrics.
3. Support and guide GPCHs in designing, implementing, and executing clinical development programs to meet decision milestones, regulatory requirements, and market access needs, in collaboration with the Head of CD Program Scientific Excellence and CDHs.
4. Represent the Head of CD Program Scientific Excellence in interactions with external stakeholders (regulatory authorities, KOLs, DMCs, advisory boards) and internal Novartis stakeholders as needed.
5. Serve as a senior expert for clinical projects, assessing Phase I-III results in preparation for new drug applications.
6. Contribute clinical input to licensing and out-licensing evaluations and participate in business development activities.
7. Assist in developing scenarios for Clinical Development to support decision-making and portfolio management.
8. Lead strategic initiatives to enhance and simplify Novartis's clinical development approach, aiming to improve speed and success rates.
9. Engage with GPCHs and the broader CD community to share learnings, support talent development, and build professional capabilities.
10. Support the Head of CD Program Scientific Excellence in fostering cross-functional collaborations and advancing towards digital clinical trials.

Key Performance Indicators

1. Successful delivery of CD program excellence initiatives and projects.
2. Effective management of C-ISRC meetings, including documentation and follow-up on action items.
3. Strong collaboration and partnerships with stakeholders.

Education (Minimum/Desirable):

• MD or PhD with extensive clinical development expertise; MD/PhD required.

Languages:

• Fluent in oral and written English.

Experience/Professional Requirements:

• Over 10 years of pharmaceutical industry experience, focusing on medical, clinical development, regulatory, and related fields. Versatile experience beyond clinical is preferred.
• People leadership experience is preferred.
• Strong external network and relationships with KOLs.
• Excellent communication skills.
• Strategic thinking capability.
• Influencing skills without formal authority.
• Experience working across matrix organizations and building partnerships.
• Oncology clinical development expertise is a plus but not required.