Clinical Development Scientist, Rare Disease/Neurology

Astellas Pharma • Northbrook, IL

4d • $144,060 - $205,800 • Hybrid

About The Position

The Clinical Development Scientist leads integrated clinical strategies for assigned rare disease and neurology programs, translating scientific, clinical, regulatory, and competitive insights into actionable development plans and governance recommendations. The role works closely with the Global Medical Lead, Clinical Operations Lead, Asset Lead, and Medical Monitor, and is accountable for the design, implementation, monitoring, and analysis of clinical studies. The scientist is expected to work independently and contribute to division- and portfolio-level initiatives.

The position provides strategic clinical and scientific leadership across multiple studies or development programs throughout the development lifecycle. It contributes to clinical trial documentation and execution, data review and interpretation, regulatory interactions, evidence generation, publications, and engagement with investigators, sites, external experts, and patient or community stakeholders. The role also supports assessment of prospective development candidates and may contribute to due diligence for potential in-licensing or acquisition.

The position is based in Northbrook, Illinois, with remote work from anywhere in the United States available. A hybrid working solution is offered, subject to company guidelines. This global role involves a highly matrixed environment, cross-regional coordination, senior leadership and governance interactions, and collaboration across European, US, and Japanese time zones.

Requirements

• Advanced degree (Ph.D., PharmD, MD, or other relevant master's degree) in a relevant scientific, health science, or clinical discipline, and at least 10 years of clinical, scientific/research, or industry-related experience, or a combination of academia and industry.
• Thorough knowledge and demonstrated expertise in biotechnology or pharmaceutical clinical drug development from early-stage development through approval, including initial study design, study execution, and regulatory submissions (INDs, BLAs, and NDAs) with US and OUS regulatory agencies.
• Experience in scientific research and/or clinical practice, evidenced by appropriate qualifications, publications, and/or relevant accreditations.
• Strong computer skills, including MS Office (Word, Excel, PowerPoint, Outlook, MS Teams, and MS Project), industry-standard software such as electronic data capture systems (e.g., RAVE or InForm), and data analysis software (e.g., Excel, SigmaPlot, SPSS, or R).
• Strong collaboration and interpersonal communication skills, including the ability to work with internal stakeholders and functions such as Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science, and Pharmacovigilance.
• Demonstrated success working with external stakeholders such as key external experts, investigators, and researchers, including presenting to and responding to Health Authorities.
• Knowledge of global pharmacovigilance standards and guidance documents.
• Comfort working in a flexible, dynamically changing, and sometimes challenging environment.
• Excellent strategic planning, organizational, verbal, and written communication skills.
• Sound judgment, tact, diplomacy, and professionalism in all interactions, with the highest level of scientific integrity.
• Ability to work independently without significant oversight or instruction, achieving results with accuracy and attention to detail.

Nice To Haves

• Experience working in gene therapy clinical studies or drug development.
• Experience with gene therapy clinical trial design and conduct, clinical data monitoring, analysis, and interpretation, including evaluation of ocular imaging and safety and efficacy assessments.
• History of providing high-level clinical strategies supporting development programs in CNS or neuromuscular indications.

Responsibilities

• Provide strategic clinical and scientific leadership across multiple studies or development programs, maintaining consistency in clinical strategy, study design, endpoints, data interpretation, and evidence generation.
• Lead and be accountable for activities related to current and planned clinical trials, including development and review of protocols, investigator brochures, CRFs, informed consents, clinical study reports, study analyses, and other trial documents.
• Synthesize and contextualize data to support cross-functional discussion and timely decision-making.
• Serve or co-lead the clinical sub-team with the Medical Lead, Clinical Operations Lead, or Medical Monitor/Study Physician; support clinical development plans, site identification and management, and Dose Escalation meetings.
• Represent Clinical Development on program teams and governance forums, presenting clinical strategy, key risks, development options, and recommendations and ensuring decisions align with the clinical development plan.
• Perform medical monitoring activities under the guidance of the study physician or medical lead, including reviewing, analyzing, and triaging patient data and generating reports.
• Independently lead working groups or sub-team initiatives supporting protocols, disease areas, or clinical development plans.
• Provide clinical leadership for major Health Authority interactions, including regulatory strategy, briefing materials and responses, participation in meetings, and translation of regulatory feedback into clinical development strategy.
• Work with the Medical Lead and Product Responsible Person on analyses for DMC/DSMB/Dose Escalation Committee forums or regulatory submissions.
• Provide training at investigator meetings and site initiation visits, and partner with Clinical Operations and Medical Affairs to support appropriate study or registry enrolment.
• Collaborate cross-functionally to create, review, or present clinical slides for internal meetings and external forums.
• Support engagement with current and potential sites through site initiation visits, investigator meetings, conferences, steering committees, and advisory board meetings.
• Provide clinical input into statistical planning, data analysis, and interpretation; demonstrate expertise in study data review and analysis.
• Provide clinical leadership and support for publication of data and disease- or technology-related scientific publications.
• Work with operations on site and vendor feasibility, trial setup, and monitoring.
• May lead execution of contracts, particularly for investigator meetings and advisory activities.
• Develop and maintain strategic relationships with external experts, investigators, patient and community stakeholders, and scientific collaborators to inform clinical strategy, study design, disease understanding, and evidence-generation plans.
• Partner with the Development Division to assess discovery candidates and identify opportunities and potential risks in future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics.
• May represent Development and assist with clinical assessment for due diligence on potential in-licensing and acquisition assets.
• Identify and lead therapeutic-area or Development Division initiatives that improve clinical development strategy, scientific quality, decision-making, or operational effectiveness beyond assigned programs.
• Perform other duties or special projects as assigned.

Benefits

• Medical, dental, and vision insurance.
• Generous paid time off options, including vacation and sick time, plus national holidays and a year-end shutdown.
• 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.
• Hybrid working solution with flexibility to work from home.

What This Job Offers

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