Medical Director, Clinical Development
1 month ago
Astellas Pharma Inc. is a pharmaceutical company with a strong commitment to developing innovative therapies for patients. We are driven to deliver effective new medicines to patients and physicians, and we are seeking a talented Medical Lead to join our team.
The Medical Lead will provide medical and strategic leadership in the planning, design, and conduct of clinical trials, enabling successful development, registration, and access of our assets to patients. This role requires a strong understanding of clinical development, regulatory affairs, and medical affairs, as well as excellent communication and leadership skills.
The primary objective of the Medical Lead is to provide medical and strategic leadership into the planning, design, and conduct of clinical trials enabling successful development, registration, and access of an asset to patients. The Medical Lead will be 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.
The Medical Lead will lead 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. The Medical Lead will also lead CGTD medical programs when required as part of post marketing requirements.
The Medical Lead will be accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Asset Lead). The Medical Lead will acquire public knowledge of present and future competitor products and how they impact the internal medical and commercial strategy. The Medical Lead will negotiate milestones and ensure clinical development objectives are met (in conjunction with Asset Lead).
The Medical Lead will plan 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. The Medical Lead will be responsible, in collaboration with Clinical Operations, for developing, recommending, adhering to the clinical development budget.
The Medical Lead will motivate global development team towards the common goal of submitting approvable regulatory filings (in conjunction with Asset Lead). The Medical Lead will be responsible for 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.
The Medical Lead will coordinate and author protocol synopses, major protocol amendments and communicate upcoming changes to the Medical Head of CGTD. The Medical Lead will provide input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
The Medical Lead may plan and convene clinical expert panel meetings and advisory boards that provide input into drug development plans. The Medical Lead will present to senior management and external audiences' various medical aspects of drug development, including milestones, strategies, and recent data and anticipate obstacles to or changes to approved plans.
The Medical Lead will incorporate Health Economics Outcomes Research requirements into protocol design. The Medical Lead will oversee medical monitoring strategy and escalate potential safety signals and concerns to the Medical Head.
The Medical Lead will serve as a people manager to monitor employee's performance, offer feedback, and encourage them to reach their professional, corporate, divisional, and asset team goals.
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