Development Physician/Medical Lead, Ophthalmology, Director

At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. 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. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity: 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. This position reports to the Global Medical Head, Biopharma and Ophthalmology Development and is based in the UK.

Hybrid Working: At Astellas we recognise 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 optimise 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.

Key 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.
• Being accountable for the design and final recommendations in the clinical development plan for their investigational product(s), after soliciting appropriate input and review from colleagues within Regulatory Affairs, Commercial, and Medical Affairs (Global and 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 (COL) 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 communicating upcoming changes to the Medical Head of Biopharma and Ophthalmology.
• 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.

Essential Knowledge & Experience:

• Extensive experience working within the pharmaceutical industry, specifically in clinical trial design and execution in a biopharmaceutical 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 medical terminology, drug development, clinical trials, and clinical research.

Preferred Experience:

• 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.

Education/Qualifications:

• MD or MD/PhD (or equivalent).
• Completion of residency in Ophthalmology with active or prior Board Certification.

This is a permanent, full-time position. This position is based in the UK. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs.

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.

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