Clinical Development Scientist, Rare Disease/Neurology

Astellas • Northbrook, IL

2d • Hybrid

About The Position

The Clinical Development Scientist leads the development of integrated clinical strategies for assigned programs, translating scientific, clinical, regulatory, and competitive insights into actionable development plans and recommendations for governance. 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, bring core clinical-development knowledge, and contribute to division- and portfolio-level initiatives.

The role provides strategic clinical and scientific leadership across studies and programs throughout the development lifecycle. It contributes to trial and program planning, study documentation, data review and interpretation, medical monitoring, health-authority interactions, publications, site engagement, and cross-functional decision-making. The position also develops external scientific relationships and may assess early-stage candidates or potential in-licensing and acquisition opportunities.

The position is based in Northbrook, Illinois, with remote work available anywhere in the United States and a hybrid working solution. It is a global role involving international stakeholders, cross-regional coordination, senior leadership and governance interaction, and collaboration across EU, US, and Japan time zones.

Requirements

• Advanced degree (Ph.D., PharmD, MD, or other relevant master’s degree) in a relevant scientific, health science, or clinical discipline.
• At least 10 years of clinical, scientific/research, or industry-related experience, or a combination of academic and industry experience.
• Thorough knowledge and demonstrated expertise in biotechnology or pharmaceutical clinical drug development from early-stage development through approval, including study design, execution, and regulatory submissions (INDs, BLAs, and NDAs) with US and non-US 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 Suite (Word, Excel, PowerPoint, Outlook, MS Teams, and MS Project), industry-standard software such as electronic data capture systems (e.g., RAVE and InForm), and data-analysis software such as 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 communication, and written communication skills.
• Ability to exercise sound judgment, tact, diplomacy, and professionalism in all interactions.
• Highest level of scientific integrity.
• Ability to work independently with limited oversight or instruction and deliver accurate work with strong 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.
• Experience evaluating ocular imaging and safety and efficacy assessments.
• History of providing high-level clinical strategies to support programs in CNS or neuromuscular indications.

Responsibilities

• Provide strategic clinical and scientific leadership across multiple studies and/or development programs, aligning clinical strategy, study design, endpoints, data interpretation, and evidence generation.
• Lead and be accountable for activities for current and planned clinical trials, including development and review of protocols, investigator brochures, CRFs, informed consents, clinical study reports, study analyses, and reporting.
• Synthesize and contextualize data for cross-functional teams to support discussion and timely decisions.
• 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, risks, development options, and recommendations and aligning decisions with the clinical development plan.
• Under guidance of the study physician or medical lead, perform medical monitoring activities, 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 Health Authority interactions, including regulatory strategy, briefing materials and responses, meeting participation, and incorporation of regulatory feedback into clinical strategy.
• Together with the Medical Lead and Product Responsible Person, potentially prepare analyses for DMC/DSMB/Dose Escalation Committee forums or regulatory submissions.
• Train clinical trial staff at investigator meetings and site initiation visits; partner with Clinical Operations and Medical Affairs to support appropriate enrollment in studies or registries.
• Collaborate across functions to create, review, and 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 boards.
• Provide clinical input into statistical planning, data analysis, and interpretation for early- and/or late-phase studies.
• 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 within the Development Division to assess discovery candidates and identify opportunities and risks in future development strategies based on modality, indication, unmet need, competition, and clinical characteristics.
• May represent development and assist with clinical due diligence for potential in-licensing and acquisition of new assets.
• Identify and lead therapeutic-area or Development Division initiatives that improve clinical strategy, scientific quality, decision-making, or operational effectiveness.
• Perform other assigned duties or special projects.

Benefits

• Medical, dental, and vision insurance.
• Generous paid time off, 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