About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This position is hybrid and will require you to be onsite 1 day per quarter in London, UK.
Astellas’ Responsible Flexibility Guidelines Statement - At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
As the Development Physician / Medical Lead - Ophthalmology (Director) you will provide input into the design and conduct of clinical trials, review and/or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assess and interpret safety data, and contribute to investigator, site staff and clinical study team training.
Role and Responsibilities
- Executing and delivering the clinical development plan (in conjunction with Asset Lead).
- Leading the global development team(s) to design, implement and conduct multi-phase development studies globally to support filing of successful regulatory submissions and supplemental filings post approval.
- accountable for the design and final recommendations in clinical development plan for their investigational product (s), after soliciting appropriate input and review from colleagues within Regulatory Affairs, Commercial, and Medical Affairs (Global / Regional), Manufacturing, Clinical Pharmacology, Statistics, Health Economics and Outcomes Research and other line functions.
- Leading Biopharma and Ophthalmology medical programs when required as part of post marketing requirements.
- Acquiring public knowledge of present and future competitor products and how they impact the internal medical and commercial strategy.
- Planning for resources required both within the Biopharma and Ophthalmology organisation and in conjunction with the Asset Lead and the Clinical Operations Lead to accomplish the objectives in a timely and resource-efficient fashion. This includes the number of employees and contractors needed.
- Coordinating and authoring protocol synopses, major protocol amendments and communicates changes to the Medical Head of Biopharma and Ophthalmology.
Continue: Role and Responsibilities
- Providing input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
- Overseeing medical monitoring strategy and escalating potential safety signals and concerns to the Medical Head.
- Extensive experience working within the pharmaceutical industry specifically in clinical trial design and execution in a bio-pharmaceutical development organisation or a balance of experience at an academic institution and a pharmaceutical company.
- Proven record of being a successful medical leader and in study design.
- Aware of cultural diversity and how to influence and manage in a multi-cultural organisation.
- Excellent writing skills with experience in writing regulatory documents and attending Health Authority interactions
- Experience managing drug development programs.
- Experience designing and planning clinical studies, to produce both timely and high-quality data.
- Proven ability to get results in a matrixed management environment.
- Proficiency with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, drug development, clinical trials, and clinical research
Required Qualifications
- MD or MD/PHD (or equivalent)
- Completion of residency in Ophthalmology with active or prior Board Certification
Preferred Qualifications
· Experience in all phases of Clinical Development and interfaces with Drug Discovery through Marketing.
- Experience working in at least one other therapeutic area outside of ophthalmology
- Experience working in cell or gene therapy drug development
What awaits you at Astellas?
· Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
· Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
· Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
· A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
· Impact
· Innovation
· Integrity
· One Astellas
· Accountability
· Courage
· Sense of Urgency
· Outcome Focus
Benefits
Careers | Astellas
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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