Clinical Scientist

Responsibilities :

• 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 on the clinical sub-team with GML, Operations Lead, and Medical Monitor / Study Physician and supports preparation of clinical development plans, site identification and management, and DESC meetings.
• 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.
• Partners with GML in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
• Together with the GML and Product Responsible Person may prepare 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 in enabling appropriate enrollment 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 interpretationProvides 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.
• Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
• Serve as key partner for 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.
• 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 needed.

Organizational Context :

• This position reports to the Primary Focus Medical Head (or other Leads depending on grade) for designated program.
• This position is typically an individual contributor role, but may have direct reports based on scope, accountabilities and complexity of assigned development programs.

If position has direct reports, will align with Astellas guidelines for span of control and organizational levels.

Requirements

Qualifications : Required :

Required :

• Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 7-10 years clinical, scientific / research, pathology 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.
• Able to travel 25%, with international travel at times.

Preferred :

• D. or PharmD degree, or other relevant Master’s degree.
• Knowledge and proficiency related to Medical Affairs activities including registries.

Benefits :

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• Country Specific Retirement Savings Plan (401k, RRSP, etc.)
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program
30+ days ago