Medical Lead
About Astellas:
At Astellas, experience is coupled energised with a relentless challenger spirit.
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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.
We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.
We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.
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.
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 one or more direct reports.
Preferred Experience:
- Experience working in Ophthalmology, cell or gene therapy drug development
- Managed drug development programs.
- Significant experience in designing and planning clinical studies, to produce both timely and high-quality data.
Education/Required Qualifications:
- Medical Degree (or Medically Qualified) with active or prior Board Certification or equivalent.
Additional information:
- This is a permanent, full-time position.
- This position is 100% home/remote based.
- This position can be based in the UK or Canada (except Quebec). Candidates interested in remote work are encouraged to apply. Remote work is permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
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.
