Purpose and Scope:

The Development Scientist will participate in the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, Asset Lead, and Development Physician. The role 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 expertise and experience in clinical development to enable increased participation in division and portfolio level initiatives.

Responsibilities and Accountabilities:

• Responsible and accountable for activities related to all current and planned clinical trials on assigned development programs (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting).
• Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussions and timely decision making.
• Serves on the clinical sub-team with Clinical lead, Operations Lead, and Medical Monitor/Development Physician; supports preparation of clinical development plans, site identification and management, and DESC meetings.
• Under the guidance of the development physician/med lead, performs medical monitoring activities (e.g., review, analyze, and triage patient data, generate study reports)
• Can independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plans.
• Partners with Clinical lead in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
• Together with the clinical lead and Product Responsible Person, prepares analysis for DMC/DSMB/DEC 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 on enabling appropriate enrollment into clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical content at internal or external meetings.
• Supports engagement with current and future clinical study sites (e.g., SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
• Shows relevant 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 groups for site and vendor feasibility, trial set up, and data monitoring.
• Leads the execution of contracts, particularly for investigator meetings and advisories.
• Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
• Serves as key partner for the Development Division in assessment of candidates within discovery, identifying opportunities and potential risks in the context of future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics.
• May represent clinical development and assist with clinical assessment of new assets for potential in-licensing and acquisition.
• Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
• Performs other duties as assigned or special projects as required.

This position is typically an individual contributor role, but may have direct reports based on experience, scope, accountabilities and complexity of assigned development programs. If the position has direct reports, will align with Astellas guidelines for span of control and organizational levels.

This position reports to the IO Development Medical Lead/Head of disease area strategy.

Required Qualifications:

• Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 7-8 years clinical, scientific/research, pathology, or industry experience; combination of academia and industry is acceptable.
• Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study start-up & execution to regulatory submissions (INDs, BLAs, NDAs) within U.S. and ex-U.S.
• 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 (e.g., 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 and impeccable work ethics.
• Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
• Able to travel ~25%, with international travel as required.

Preferred Qualifications:

• Ph.D., PharmD, or other relevant master's degree.
• Knowledge and proficiency related to Immuno-Oncology clinical research

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.

Salary Range

$170,450 - $243,500 (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
• Referral bonus program

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