VP Clinical Development Ophthalmology
• Position: VP Clinical Development
• Therapy Area(s): Ophthalmology
• Company: medium sized biopharmaceutical
• Location: Boston, Massachusetts, USA
• Remote Working: possible, coupled with onsite working
• Type: Permanent, full-time
• Salary/Compensation: competitive /market value
• Ref: OM21544
An exciting opportunity to join a rapidly growing and highly innovative biopharm company, with a promising pipeline consisting of drug candidates at both discovery stage and clinical development, coupled with marketed products in Ophthalmology.
The VP Clinical Development is a senior leadership level position, in a fast-paced and passionate environment, with the aim of developing unique therapies to commercialization.
You will deliver value through the integration of advanced clinical decision making and approaches for crucial deliverables in drug development.
You will build and lead a team of clinical professionals, strengthening the company's medical expertise and regulatory submissions.
You will work across all Company projects, collaborating frequently with relevant internal functions, including R&D, Commercial, Project Leaders and Regulatory Affairs, whilst leading the Clinical Development activities.
• Lead the Clinical Development division through the planning, design, development and implementation of clinical trials for all products in all clinical phases
• Support in the overall company strategy and company trajectory
• Liaising with KOLs to create clinical development strategies for relevant products
• Provide oversight of PV and manage the reporting of safety signals to regulatory agencies in a timely manner
• Guide R&D/Discovery team on decisions with clinical implications
• Management of the writing of protocols, presentations and publications
• Review key documents including protocols, IBs and informed consent forms
• Close collaboration with Clinical Operations to make strategic decisions on regarding outsourcing and in-house approaches
• Working to the highest standards, following relevant guidelines (ICH-GCP)
• MD with excellent industry experience
o Experience in a small to mid-sized biotech company is preferred
o Ophthalmology clinical background is preferred
• Proven experience of successful drug development in Phase I-III
• Excellent communication (verbal and written) and leadership skills with a willingness to perform hands on duties to contribute to team efforts as required
• A history of publications and strong presentation skills to influence relevant audiences
• Ability to implement creative and innovative approaches where necessary
• Regulatory experience: Pre-IND, IND, EOP 2 meetings, CTA and NDA/BLA/MAA (US and Global)
HOW TO APPLY
• Please send an email, with a copy of your CV attached to Oliver Morkel (email@example.com)
• In your email, please include the job reference number OM21544