Purpose and Scope: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.
Responsibilities and Accountabilities:- 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
- Investigators/KOL engagement: Development Physician is responsible for KOL/investigators scientific engagement.
Required Qualifications:- 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.
Preferred Qualifications:- Active or prior Board Certification
- Prior experience working at another Biotechnology, Pharmaceutical company or CRO
- Experience working in cell or gene therapy drug development
Location and Working EnvironmentThis position is based in Northbrook, IL. Remote work from anywhere in the US is available.
At Astellas we recognize 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 optimize 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.
This position is a global role with strong interaction with various disciplines and international stakeholders
- Highly matrixed environment requiring cross-regional coordination.
- Frequent interaction with senior leadership and governance bodies.
- Collaboration across EU, US, and Japan time zones.
Salary Range$207,192 - $295,988 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
*The salary range provided applies to US only and does not apply to any other locations outside of the US
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
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