Clinical Development Physician, Ophthalmology (Medical Director)

Astellas Pharma • Northbrook, IL

11d • $207,192 - $295,988 • Hybrid

About The Position

The primary objective for the Development Physician is to provide input into 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. 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.

Requirements

• Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology
• Willingness to work across different ophthalmic indications
• Should have at least 8 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 5 years working in clinical development
• Excellent scientific writing skills
• Ability to read and analyze ocular images
• Experience analyzing, synthesizing, and communicating clinical trial data
• 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.

Nice To Haves

• Active or prior Board Certification
• Prior experience working at another Biotechnology, Pharmaceutical company or CRO
• Experience working in cell or gene therapy drug development

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 Global Safety Officer.
• 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 Serious 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.
• 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: 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.
• In collaboration with the Medical Lead: Investigators/KOL engagement: Development Physician is responsible for KOL/investigators scientific engagement.

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
• Company fleet vehicle for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior