Clinical Scientific Expert, Group Head

Healthcare Businesswomen’s Association; London; Hybrid; GBP 60,000 - 100,000; Full time

Job description

Job Description Summary

This role is responsible for driving the strategy, development and execution of Clinical Scientific Excellence in compliance with Novartis processes, ICH GCP and regulatory requirements. The Group Head reports to Head CSE and supports Senior Leaders from the business and functions within Global Drug Development (GDD) to help to progress how Novartis innovates, engages and operates.

The Development Units will be a key stakeholder and interactions will primarily focus on CSE support of Clinical Trials. Drives cultural change in the company, direct, oversee and coordinate all activities, deliverables and resources within CSE group and Development unit(s).

The CSE role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The Group Head is expected to act as a leader on any cross-organizational governing body on clinical data review strategies through local and global level initiatives.

This role is based in the UK / London and in a hybrid working approach.

Job Description

Main Accountabilities but not limited to:

• Accountable for Leadership and Management of Clinical Scientific Experts (CSE I/II):
• Selects, recruits, develops, manages, motivates, coaches and appraises the performance of direct reports to ensure high quality performance and support career development through quality development plans across the CSE Team.
• Manages and coordinates the assignment of resources and workload within group or disease area, and ensures sharing of resources between groups in order to meet company objectives and priorities.
• Provides all necessary support to help address and resolve issues. Identifies solutions for remediation.
• Builds and establishes a strong team spirit and creates a team founded on clinical and scientific expertise, technical ability, excellence in performance and exhibiting the Novartis values and behaviours.
• Leads and supports special projects and initiatives/highlights the need for training programs and supports the establishment of these (technical and professional skills) for CSE group and ensure staff training is conducted and properly documented.
• May act as a Subject Matter Expert for key operational areas influencing Clinical Scientific Expert Group and wider area of Clinical Development.
• In collaboration with QA, manage audits and regulatory inspections and create an audit readiness working environment. Understands Health Authority requirements and is able to participate in Health Authority inspections as required.

Education & Experience

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
• ≥3 years scientific, strategic and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia, or 5+ years in Clinical Operations/Clinical Scientific role.
• >5 years experience in team/matrix management preferred.
• Intermediate to Advanced knowledge with hands-on experience in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization or similar experience with an academic research institution.
• Understanding of principles of well-designed clinical trials, including trial objectives, sample size rationales, defined trial population, methods for eliminating or minimizing bias, bio-statistical analysis methods, outcome measures, interpretation of results & ethics.
• Medical/scientific expertise with a good understanding of medical/scientific writing skills.
• Prior experience of scientific partnership with investigators.
• Strong scientific knowledge of assigned therapeutic area(s) is desired (e.g., understanding of basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcomes). Show capability to interpret, discuss and represent trial or program level data.
• In-depth knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
• Thorough knowledge of principles of clinical data collection and reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Experience in Rave and/or OC-RDC is an advantage.
• Superior people management skills with demonstrated positive leadership, innovative, and collaborative behaviours.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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Skills Desired: Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring.