Medical Lead (Ophthalmology) Clinical Development - Executive Director
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing 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 Medical Lead, you will join a diverse and agile team and contribute to 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.
Your role will report to the Global Medical Head, BioPharma Development.
This is a global position that is primarily based in the UK or EU4 major markets.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Responsibilities:
- 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.
- Designing and providing the final recommendations for the clinical development plan for assigned 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 on Cell & Gene Therapy Development medical programs when required as part of post marketing requirements.
- Being accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Asset Lead).
- Planning for resources required both within the Cell & Gene Therapy Development organization 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.
Essential Knowledge & Experience:
- Extensive relevant experience in drug development in a biotech/pharmaceutical company or equivalent experience in an academic clinical research institute (NCI, NIH, Academic Research groups, etc).
- Motivating the global development team towards the common goal of submitting approvable regulatory filings (in conjunction with Asset Lead).
- Coordinated and authored protocol synopses, major protocol amendments and communicates upcoming changes to the Medical Head of Cell & Gene Therapy Development.
- Overseen medical monitoring strategy and escalate potential safety signals and concerns to the Medical Head. Contributed to the input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
- Served as a people manager to monitor employee’s performance, offer feedback, and encourage them to reach their professional, corporate, divisional, and asset team goals. Experienced in managing three or more direct reports.
Preferred Experience:
- Managed drug development programs.
- Significant experience in designing and planning clinical studies, to produce both timely and high-quality data.
Education:
- Medical Degree with residency in Ophthalmology and active/prior Board Certification or equivalent experience.
Additional information:
- This is a permanent full-time position.
- This is a global position that is primarily based in the UK or EU4 major markets.
- 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. Candidates must 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.
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