Medical Lead, Clinical Development, Ophthalmology

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ~~~ .

This position is based in Northbrook, Illinois, South San Francisco, California, or Cambridge, Massachusetts. Remote work from certain regions may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

This highly visible position will provide medical leadership within clinical development to IZERVAY's launch and lifecycle management, including health authority planning and interactions. In general, the global medical lead also encompass the below:

• Accountable and responsible for development and implementation of a global medical development plan on a large complex late-phase project or on a group of complex earlier-phase projects.

• Serves as global medical lead (GML) or study physician on one or multiple Cell and Gene Therapy Development (CGTD) Asset teams on early and late stage, complex projects.

• Responsible for designing and conducting a global medical program resulting in quality regulatory submissions.

• Responsible for the medical interface with research through regulatory authorities and the commercial organization.

• Provides medical leadership on the Global Project Team and chairs the Medical Extended Team meetings.

• Supports to other projects as required.

Essential Job Responsibilities:

• Accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Medical Lead and Asset Lead.

• Provides medical safety monitoring for ongoing clinical trials

• Review and submit queries in clinical trial databases

• Provides input and medical review of clinical trial documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.

• Responsible for design and 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.

• Supports or act as medical lead 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.

• Acquires public knowledge of present and future competitor products and how they impact the internal medical and commercial strategy.

• Negotiates milestones and ensures clinical development objectives are met (in conjunction with Asset Lead).

• Responsible, in collaboration with Clinical Operations, for developing, recommending, adhering to the clinical development budget.

• Motivates global medical team towards the common goal of submitting approvable regulatory filings (in conjunction with Asset Lead).

• 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.

• Coordinates and authors protocol synopses, major protocol amendments and communicates upcoming changes to the Medical Head of CGTD.

• May plan and convene clinical expert panel meetings and advisory boards that provide input into drug development plans.

• Presents to 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.

• Incorporates Health Economics Outcomes Research requirements into protocol design.

• Escalate potential safety signals and concerns to the Medical Head.

Quantitative Dimensions:

• Collaborates with Medical Directors across TA and may have oversight of development scientists and study physician contractors.

• Budget: allocated to the Global Asset Team budget.

• Responsible for decisions and advice in scientific, clinical and/or technical areas that can impact development timelines/regulatory review periods/acceptance and create significant delay or additional costs.

Organizational Context:

• Reports to the Medical Head or Medical Lead in CGTD

• Matrixed relationship to colleagues on the Global Asset Team, Clinical Operations, Statistics, Regulatory Affairs, Clinical Pharmacology and Medical Affairs.

• Collaborates with the Asset Leads in assuring the smooth function of the Global Project Team.

• Accountable for integrating medical aspects of the project with the Asia Development colleagues and with colleagues running country specific registrational studies.

Qualifications:

Required

• Medical Degree (or Medically Qualified) with completion of residency or fellowship in Ophthalmology and clinical development experience.

• Experience working in Ophthalmology clinical trials

• Experience reviewing Ophthalmology clinical trial data including images

• Willingness to work across different indications related to Ophthalmology

• At least 3 years 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) with at least 2 years working in a corporate environment

• Excellent writing skills with experience in writing regulatory documents or grants

• Experience designing and planning clinical studies

• Knowledge of ophthalmology clinical trial endpoints

• Proficient reviewing various retina images

Preferred

• Prior experience as a medical monitor or drug safety physician

• Prior experience as site PI or sub-I

• Experience working in Cell or Gene Therapy

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

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Category Cell and Gene Therapy Development

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans