Job Description Summary

LOCATION: London or UK Homeworker, Dublin, Barcelona or Madrid
ROLE TYPE: Hybrid Working, #LI-Hybrid

The Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds. The GPCH owns the risk benefit assessment for the program(s), and as the leader of Global Clinical Team(s) (GCT) is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements and market access. The GPCH may contribute to disease area strategy.

Job Description

Major accountabilities:

• Leads the GCT, represents Clinical Development on the (early) Global Program Team (GPT)

• May serve as the Clinical Development Representative on NIBR clinical/project teams or early GPT to drive transition of pre-PoC (Proof of Concept) projects to Transition Decision Point (TDP)

• May support Business Development & Licensing (BD&L) activities

• Leads the development and execution of the clinical strategy. Develops an endorsed Clinical Development Plan (CDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs

• Leads the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator's Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers)

  with high quality and consistency with CDP and TPP. Supports registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the compound(s)

• Together with Global Clinical Operations, oversees the implementation of the clinical development program (including clinical trials) and identifies and mitigates clinical risks

• Together with Patient Safety, ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance. Serves as a core member of the Safety Management Team (SMT)

• As the medical expert, leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy

  groups), internal stakeholders (e.g., Research, Translational Medicine, Global Medical Affairs (GMA), Marketing, Health Economics & Outcomes Research), and internal decision boards

• Supports CDH with leading the peer-review of CDPs, CTPs, and other clinical documents across various indications and programs; and with driving excellence across clinical trial strategy, design, and execution

• May contribute to development of disease area strategies

• Plans and executes publication and clinical communication strategy in coordination with Global Innovative Medicine and Medical Writing, and provides input into key external presentations

• Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program(s)

• Ensures career development of program reports through active participation in the performance management, talent review, and succession planning processes. Provides on-boarding, coaching,

  and/or mentoring support; develops and fosters Clinical Development culture; and contributes to the performance evaluation of GCT members

• Responsible for medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training

• Leads or serves on global process improvement work streams, acts as Subject Matter Expert for standard operating procedures or trainings, and/or contributes to other cross-functional or Clinical Development line function initiatives

Education (minimum/desirable):

• MD or equivalent (preferred), PhD, or PharmD degree required.

• Specialization in a subspecialty may be needed. Experience in Neuroscience, Neuromuscular and/or Neurodegeneration strongly preferred. Cell and Gene Therapy experience a plus.

• Advanced clinical training/knowledge in medical/scientific area aligned with TA required.

• Medical Board certification preferred for MD or equivalent;

• Clinical practice experience ≥ 4 years (including residency) preferred for MD or equivalent

Languages: Fluent oral and written English

Experience/Professional requirement:

• ≥6 years (MD or equivalent)/ ≥ 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
• Advanced knowledge of assigned therapeutic area required, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
• Experience with submissions and health authorities required
• Demonstrated ability to establish strong scientific partnership with key stakeholders
• Demonstrated leadership and management skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry
• ≥ 5 years people management experience required; this may include management in a matrix environment
• Considerable organizational awareness including significant experience working cross-functionally and in global teams
• Excellent management, interpersonal, communication (both written and oral), and problem-solving skills
• Excellent negotiation and diplomatic skills

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.

#LI-hybrid

Skills Desired

Budget Management, Clinical Trials, Coaching, Compliance, Cross-Functional Teams, Leadership, People Management, Risk Management, Risk Monitoring, Strategy