Global Program Clinical Head - Ophthalmology
A job vacancy for a Global Program Clinical Head - Ophthalmology has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
- Leading the Global Clinical Team (GCT).
- Acting as the clinical development representative at the Global Program Team (GPT).
- Leading the development and execution of the Clinical Development Plan (CDP), adhering to company clinical/data standards for Phase II - III trials designed for successful global registration of the compound.
- Ensuring individual protocols are consistent with CDP and are aligned to achieve the Target Product Profile (TPP).
- Leading the creation of clinical components of key documents (regulatory documents, registration dossiers, value dossiers, and pharmacoeconomic dossiers) supporting registration, market access, and commercialization of the compound(s).
- Supporting the Clinical Science Unit/CSU Head, driving excellence in clinical trial strategy, design, and execution; this includes CDP, Executable Synopsis (ES), protocol reviews, and development of disease/program clinical standards.
- Working as part of the CSU by leading clinical interactions with external and internal stakeholders and support NIBR/Translational Sciences, especially in driving the transition of pre-PoC projects to DDP and BD&L (including target identification and due diligences together with other medical matters as needed).
- Acting as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Translational Sciences, Global Medical Affairs, Marketing, HE&OR), and internal decision boards.
- Continuously evaluating drug safety profile, including the aspects of relevance to patients in clinical studies, as well as external stake holders (e.g., health authorities) with support from Drug Safety & Epidemiology.
- Ensuring compliance and adherence to clinical quality initiatives and plans.
- Ensuring the quality of all clinical documents (e.g., Investigators' Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents) produced by the Global Clinical Team (GCT).
- Delivering all relevant components/documents for maintenance of product licenses (e.g., Core Data Sheet generation/revision, clinical benefit-risk assessments for license renewals, and responses to Health Authority).
Skills and Requirements:
- MD or equivalent required.
- Advanced knowledge in ophthalmology required.
- Development in an academic or industry environment, spanning clinical activities in Phases I through III (some industry experience preferred).
- Over 5 years of demonstrated leadership, management, and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing), or section of clinical programs in a global/matrix environment (including remote) in pharmaceutical or biotech industry.
- Over 5 years of people management experience required, which may include management in a matrix environment (direct report management experience preferred).
- Global people management experience desirable.
- Demonstrable experience in data presentation.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Russell at +44 203 824 6104 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.