Associate Medical Director, Therapy Area Lead, Ophthalmology
About Astellas:
At Astellas we offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company, our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword, it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team, or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best minds together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
About This Job:
With the recent integration of Iveric at Astellas and EMA approval for regulatory review of the product, we have a new opportunity in the UK Affiliate for a Therapy Area Lead for Ophthalmology.
With the macular degeneration treatment accepted for review by EMA, this will be a busy and exciting opportunity in a new area for Astellas. Reporting to the Affiliate Medical Affairs Head, in this role you will be responsible for providing medical and scientific expertise and guidance for Ophthalmology throughout the product lifecycle, from pre to post launch.
With your knowledge of Ophthalmology, you will be responsible for oversight and delivery of Medical Affairs (MA) activities for the therapy area and develop/maintain integrated partnerships with stakeholders internally and externally. You will also ensure that the MA deliverables address local business needs to bring value to patients and advance the medical/scientific understanding of the product
Hybrid working:
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
Key activities are noted below:
- Provide strategic leadership and direction across the MA department to ensure all MA activities/deliverables are based on scientific validity, clinical importance, fiscal feasibility and in alignment with Core Medical Plans and local business needs.
- Develop a clear understanding and insight into the TA area objectives and support the development of such objectives. Understand patient treatment pathway and strategically leverage regional and/or global medical initiatives to meet local business needs. Work on MHRA pre vetting
- Ensure medical input into brand/launch planning, preparation and approval of materials, product presentations, publication plan development and implementation
- Full engagement in external meetings, advisory boards and symposia as required
- Engage and build relationships with Key External Experts, other HCPs, and Professional/Regulatory bodies
Essential Knowledge & Experience:
- Solid Medical Affairs experience from within the Pharmaceutical Industry alongside strong knowledge of local Regulatory/Payer/HTA bodies, ICH GCP/ABPI guidelines, Industry regulations, and quality standards.
- Scientific problem-solving capabilities, able to think strategically and manage key projects with a track-record of leading planning processes. Clear understanding of core medical planning and the drug development lifecycle
- Provide meaningful MA Value metrics, quality assurance controls, and operational assessment/analysis plans relevant to MA activities and deliverables
- Experience of working with cross functional teams providing medical input/scientific rigour around the product for launch planning activities and preparation. Proven ability to influence and engage with diverse senior stakeholders at an affiliate, regional and global level
- Understanding of the MHRA pre vetting and UK licencing process and solid understanding of NICE process
Education/Qualifications:
- MD or equivalent – qualification in Ophthalmology preferred
Additional information:
- This is a full-time, permanent position based in the UK
- The position follows our hybrid working model with a blend of home and a minimum 1-day per quarter in our Addlestone office. Flexibility may be required in line with business need. Candidates should be located within a commutable distance of the office
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.