Clinical Development Physician, Medical Director, Ophthalmology

Astellas PharmaRemote

Stellenbeschreibung:

This role reports to the Global Medical Lead, Global Medical Lead, Biopharma and Ophthalmology Development. This is a hybrid position and will require you to be onsite 1 day per quarter at Bourne office in London, UK.
At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

Purpose and Scope

As a Development Physician (Medical Director), you will play a key role in the design, execution, and oversight of global clinical studies.
You will contribute to protocol and study design, develop and review key study documents, provide medical monitoring and safety oversight, interpret clinical and safety data, and support the training of investigators, site staff, and cross-functional study teams to ensure successful trial delivery.

Role and Responsibilities

In collaboration with the Medical Lead, responsible for designing and making recommendations in the clinical development plan that are aligned with the asset development strategy, after soliciting appropriate input and review from Medical and Clinical Operations colleagues as well as other contributing line functions (Regulatory Affairs, Statistics, Clinical Operations, Commercial).
Be available to advise on assigned clinical trial(s) related medical questions or problems during the trial, including 24/7 emergency coverage for safety-related matters.
Reviews and analyzes the eligibility of participants per inclusion/exclusion requirements of a clinical trial.
Reviews all adverse events to look for trends or risks, reviews all serious adverse events (SAEs), including review of the narrative, investigators' assessment on causality, and applicable regulatory reporting, with close collaboration with the study's Product Responsible Person (PRP)
Provides review of study protocols and ongoing medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed. Ensures activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOPs and regulations. Includes writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.

Continue: Role and Responsibilities

Consults with internal and external stakeholders in the development of clinical trial design and conduct, including drafting of protocols and amendments.
Develops and/or reviews operational, medical monitoring, and safety plans for studies.
Leads and/or participates in scientific and medical training of other team members and external clients, investigators, and other site staff as it pertains to assigned studies.
Generates safety-related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
In collaboration with the Medical Lead: Participate in Health Authorities communication: the Development Physician is responsible for clinical written feedback/response to deficiency letter, pre-IND/NDA communication meeting, or panel review meeting
Investigators/KOL engagement: Development Physician is responsible for KOL/investigators scientific engagement.
Medical Degree (MD) or equivalent required. We also welcome applications from qualified Optometrists with relevant ophthalmology and clinical development experience.
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.)
Proven record of being a successful medical leader and in study design.
Excellent writing skills with experience writing regulatory documents and attending Health Authority interactions
Experience managing drug development programs.
Experience designing and planning clinical studies, to produce both timely and high-quality data.
Proven ability to get results in a matrixed management environment.
Proficiency with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, drug development, clinical trials, and clinical research.

Preferred Experience

Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology with active or prior Board Certification
Experience working in at least one other therapeutic area outside of ophthalmology
Experience working in cell or gene therapy drug development
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com

Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.