Cette offre d'emploi n'est plus disponible
À propos
If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.
LOCATION: London or UK Homeworker, Dublin, Barcelona or Madrid.
Role Type
ROLE TYPE: Hybrid Working.
About the Role
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.
Major Accountabilities
- Leads the GCT and represents Clinical Development on the early Global Program Team (GPT).
- Might serve as the Clinical Development Representative on NIBR clinical/project teams or early GPT to drive transition of pre‑PoC projects to the Transition Decision Point (TDP).
- Might support Business Development & Licensing (BD&L) activities.
- Leads the development and execution of the clinical strategy, creating an endorsed Clinical Development Plan (CDP) aligned with the Target Product Profile (TPP) for successful global regulatory approval and market access.
- Leads creation of key clinical documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with CDP and TPP.
- Works with Global Clinical Operations to oversee implementation of the clinical development program, identifying and mitigating clinical risks.
- Works with Patient Safety to ensure continuous evaluation of the drug safety profile, including safety monitoring and signal detection from post‑marketing surveillance, and serves as a core member of the Safety Management Team (SMT).
- Leads interactions with external stakeholders (regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcomes Research) and internal decision boards.
- Supports CDH by leading peer‑review of CDPs, CTPs, and other clinical documents, driving excellence across trial strategy, design, and execution.
- Might contribute to the development of disease area strategies.
- Plans and executes publication and clinical communication strategy in coordination with Global Innovative Medicine and Medical Writing, providing 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 participation in performance management, talent review, and succession planning, providing onboarding, coaching, and mentoring support, and fostering a Clinical Development culture.
- Responsible for medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule, and 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 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 of ≥ 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 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 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 the 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.
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, combined to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? xcfaprz and Rewards
Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB).
#J-18808-Ljbffr
Compétences linguistiques
- English
Cette offre a été publiée par l’un de nos partenaires. Vous pouvez consulter l’offre originale ici.