Astellas Pharma

Key Responsibilities

• • Collaborates effectively with key internal and external stakeholders as a member of the asset team and leader of the clinical study team to advance one or more clinical trials.
• • Serves as Medical Monitor w/ responsibility for safety monitoring. Ensures patient safety on clinical study is maintained.
• • Generates safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
• • Collaborates closely with safety officer in writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
• • Coordinates with Safety Officer on program for appropriate benefit-risk assessments, planning FIH study dose selection and escalation path for early-phase programs, safety management on trials, provides clinical input and review of clinical documents, statistical analysis plans, interim and final analyses on trials, publications, CSRs, DSURs and other critical documents.
• • Able to assimilate Research, Clinical Pharmacology, Biomarker, medical safety, Toxicology (early phase programs) regulatory, biostatistics, medical affairs, Health Economics, commercial perspectives into clinical development strategies and trial designs.
• • Responsible for managing the process of development of protocol and necessary regulatory documents.
• • Accountable and responsible for development and implementation, and execution of clinical trials as part of a large complex late phase (post POC, established market) program or a group of earlier stage programs, in alignment with Asset and overall clinical strategy.
• • In late phase program serves as the Lead for an indication specific clinical development team and is responsible and accountable for both strategy and execution of the clinical development plan for that indication or line of therapy.
• • In earlier phases, serves as the clinical lead for the entire clinical development strategy and execution for a given program.
• • Acquires public knowledge regarding therapeutic landscape, potential competitor products and serves as clinical voice regarding the potential for impact on planned clinical, medical affairs and commercial strategies.
• • Creates and maintains scientific/clinical networks and seeks external opinion leader as appropriate.
• • Serve as the clinical interface during clinical advisory boards, investigator meetings, and interactions with opinion leaders.
• • Serves as the clinical interface in regulatory authority interactions.
• • Accountable for clinical development milestones for their given trials.
• • Supports Medical lead and Asset team at governance meetings and is able to present the clinical development plan in a succinct and clear manner at such meetings.
• • Works with Development Scientists and Clinical Operation Leads to ensure efficient and streamlined execution of clinical trials and acquisition and interpretation of high-quality clinical data to inform program-level decision making and overall development strategies.
• • Designs scientifically rigorous, cost-effective, and patient-centric clinical trials in accordance with the Clinical development Plan.
• • Accountable for Clinical trial scope development and authoring of the protocol, IB, ICF as appropriate, in coordination with development scientists, clinical operations, medical writing and regulatory.
• • Responsible for keeping medical lead, asset lead and Development Head informed on progress of trials, risks, planned/required mitigations, and changes to timelines and budgets.
• • Supports clinical development related initiatives as needed.
• • Leads and/or participates in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies.