Purpose and Scope:

The Global Medical Lead (GML), Biopharma and Ophthalmology Development (BOD), will lead the clinical development of 1 or more biopharmaceutical research programs at any stage from pre-clinical to approval, with a focus on gene therapies. The GML will join a team of physician scientists reporting to the Global Medical Portfolio Lead, Biopharma and support the overall mission of BOD to create VALUE for patients.

Responsibilities and Accountabilities:

• Oversee ongoing clinical trials to ensure the safety and well-being of clinical trial participants.
• Design the overall clinical development plan for their assigned programs.
• Draft protocols and supporting documents required to conduct individual clinical trials.
• Direct a team of one or more development scientists and/or physicians in pursuit of program goals.
• Contribute to global regulatory submissions.
• Analyze, interpret, and disseminate clinical trial data internally and externally.
• Prepare written and visual materials required for internal decision-making.
• Collaborate with personnel from operations, regulatory, biostatistics, project management etc.
• Educate and advise internal stakeholders as a subject matter expert in clinical medicine.
• Engage with external stakeholders including physicians, regulators, advocates, patients, and caregivers.
• Evaluate the clinical development feasibility of new business opportunities.

Required Qualifications:

• Doctor of Medicine (M.D.), or equivalent degree from an accredited medical educational institution
• Board certification (active or prior) in a relevant specialty, such as general pediatrics or child neurology
• Unrestricted medical licensure in one or more jurisdictions
• 3 or more years of clinical practice experience
• 3 or more years of biopharmaceutical industry experience
• Proficiency with written, visual, and oral communication of medical knowledge
• Proficiency with Microsoft Office (Word, Excel, Power Point, One Note, Outlook, Share Point, and Teams)
• Proficiency with accessing, reading, and interpreting primary medical and scientific literature
• Proficiency with work in a cross-functional, matrixed, work environment
• Proficiency with people of diverse cultural backgrounds and geographic origins
• Working knowledge of biostatistics
• Valid identification and up-to-date vaccination history to facilitate domestic and international travel
• Significant and demonstrated knowledge of regulatory procedures and guidelines in all regions (global scope)
• Proven track record in clinical study design, monitoring and execution and results analysis
• Has demonstrated knowledge of designing, implementing and conducting clinical studies, to produce both timely and good quality data.
• Proven record of working on teams and in a matrix environment.
• Proven ability to get results in a matrix management environment.

Preferred Qualifications:

• Training in a relevant subspecialty, such as clinical genetics and genomics, critical care, neuromuscular medicine, clinical neurophysiology, epilepsy, or neurodevelopmental disabilities
• Clinical research experience as a site investigator or sub-investigator on a clinical trial
• D., M.S., post-doctoral laboratory research experience, or equivalent scientific training
• At least 1 scientific or clinical publication
• At least 1 scientific or clinical presentation at a regional or national meeting
• Phase 1 clinical trial experience
• Rare disease expertise
• Experience working in gene therapy or pediatric drug development
• S. F.D.A. Pre-IND, IND, and BLA submission experience
• U. E.M.A. CTA and MAA submission experience
• Proficiency with Medidata Rave and Veeva Vault
• Working knowledge of artificial intelligence system use (e.g., Microsoft CoPilot)
• Experience in development and implementation of global clinical trials for the registration and support of new molecular entities worldwide

Location and Working Environment

This 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)

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

#LI-SS