Clinical Development Scientist, Rare Disease/Neurology

About Astellas

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. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope:

The primary purpose of the Development Scientist will lead in the development of integrated clinical strategies for assigned translating scientific, clinical, regulatory, and competitive insights into actionable development plans and recommendations for governance. This position will work 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 conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core knowledge of clinical development to enable increased participation in division and portfolio level initiatives.

Responsibilities and Accountabilities:

• Provides strategic clinical and scientific leadership across multiple studies and/or development programs, ensuring consistency of clinical strategy, study design, endpoints, data interpretation, and evidence generation across the development lifecycle.
• Responsible and accountable for activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting) on assigned development programs.
• Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making.
• Serves or co-leads the clinical sub-team with Medical Lead, Clinical Operations Lead, or Medical Monitor/Study Physician and supports preparation of clinical development plans, site identification and management, and Dose Escalation meetings.
• Represents Clinical Development at program level teams or governance forums, presenting clinical strategy, key risks, development options, and recommendations and ensuring alignment of resulting decisions with the clinical development plan.
• Under the guidance of study physician/med lead, perform medical monitoring activities (review, analyze and triage patient data, generating reports)
• Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
• Provides clinical leadership for major Health Authority interactions, including development of clinical regulatory strategy, preparation of briefing materials and responses, participation in Health Authority meetings, and translation of regulatory feedback into clinical development strategy.
• Together with the Medical Lead and Product Responsible Person may prepare analysis for DMC/DSMB/Dose Escalation Committee forums or regulatory submissions.
• Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs in enabling appropriate enrolment into the clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
• Supports engagement with potential and current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
• Early and/or late phase studies
• Exhibits expertise related to Study Data Review and Analysis:
• Provides clinical input into statistical planning, data analysis and interpretation
• Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease or technology related scientific publications
• Works closely with operations group for site and vendor feasibility, trial set up and monitoring.
• May lead the execution of contracts, particularly for investigator meetings and advisories.
• Develops and maintains strategic relationships with leading external experts, investigators, patient/community stakeholders, and scientific collaborators to inform clinical strategy, study design, disease understanding, and evidence-generation plans.
• Serve as key partner within Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with 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(s) of new assets for potential in-licensing and acquisition.
• Identifies and leads therapeutic-area or Development Division initiatives that improve clinical development strategy, scientific quality, decision-making, or operational effectiveness beyond assigned programs.
• Performs other duties as assigned or special projects as needed.

Required Qualifications:

• Advanced degree (Ph.D., PharmD, MD or other relevant Master’s degree) in a relevant scientific discipline; health science or clinical discipline with at least 10 years clinical, scientific/research, or industry related experience or combination of academia and industry.
• Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early stage development through approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies.
• Experience in scientific research and/or clinical practice (as 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) and in the use of industry-standard software (e.g. electronic data capture systems [RAVE, InForm, etc.]) and proficient in data analysis software (Excel, SigmaPlot, SPSS, R, etc.).
• Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV).
• Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
• Knowledge of global pharmacovigilance standards and guidance documents.
• Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
• Excellent strategic planning, organizational and verbal 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 without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.

Preferred Qualifications:

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

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.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$144,060 - $205,800 (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