Medical Lead

Job title:

Medical Lead

Company

Astellas Pharma

Job description

Medical LeadAbout Astellas:At Astellas we can 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 brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.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:

• Accountable and responsible for 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 and Regional), Manufacturing, Clinical Pharmacology, Statistics, Health Economics and Outcomes Research and other line functions.
• Leads 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.
• Leads CGTD medical programs when required as part of post marketing requirements.
• Accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Asset Lead.
• Plans for resources required both within the CGTD 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:

• Motivates global development team towards the common goal of submitting approvable regulatory filings (in conjunction with Asset Lead).
• Demonstrable experience in keeping Asset Lead, other project physicians and scientists, and management informed of clinical progress and any critical medical issues and especially the emerging safety profile.
• Coordinates and authors protocol synopses, major protocol amendments and communicates upcoming changes to the Medical Head of CGTD.
• Provides input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
• Oversees medical monitoring strategy and escalate potential safety signals and concerns to the Medical Head.
• Serves 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 at least one other therapeutic area outside of ophthalmology
• Experience working in cell or gene therapy drug development
• Experience managing drug development programs.
• Experience designing and planning clinical studies, to produce both timely and high-quality data.

Education/Qualifications:

• Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology with active or prior Board Certification.
• Willingness to work across different ophthalmic indications.
• 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).

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 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.

Expected salary

Location

United Kingdom

Job date

Sat, 24 Aug 2024 07:12:13 GMT

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