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Clinical Development Specialist

2 months ago

Markham, Ontario, Canada Astellas Pharma Inc. Full time
Job Summary

Astellas Pharma Inc. is seeking a highly skilled Clinical Scientist to join our team. As a Clinical Scientist, you will be responsible for leading the development and execution of clinical trials, providing expertise to cross-functional teams, and serving as a key partner for Development Division.

Key Responsibilities
  • Lead Clinical Trials: Develop and execute clinical trial protocols, investigator brochures, CRFs, informed consents, and clinical study reports.
  • Provide Expertise: Synthesize and contextualize data to facilitate discussion and timely decision making.
  • Support Clinical Development Plans: Prepare clinical development plans, site identification and management, and DESC meetings.
  • Medical Monitoring: Review, analyze, and triage patient data, generating reports under the guidance of study physician/med lead.
  • Lead Working Groups: Independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
  • Partner with GML: Prepare for Health Authority (HA) Meetings and assist in addressing HA inquiries.
  • Support Regulatory Submissions: Prepare analysis for DMC/DSMB/DEC forums or regulatory submissions.
  • Train Clinical Trial Staff: Provide training at investigator meetings and site initiation visits with clinical trial staff.
  • Collaborate Cross-Functionally: Create, review, and/or present clinical slides for internal meetings and external forums.
  • Support Site Engagement: Engage with potential and current sites, including SIVs, investigator meetings, conferences, steering committee, advisory board meetings.
  • Exhibit Expertise: Provide clinical input into statistical planning, data analysis, and interpretation, and lead the execution of contracts.
  • Support Strategic Partnerships: Develop strategic partnerships with Key External Experts (KEEs).
  • Assess Candidates: Serve as a key partner for Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies.
  • Represent Development: Represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition.
  • Support Strategic Initiatives: Support strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio.
Requirements
  • Advanced Degree: 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: 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.
  • Scientific Research: Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations).
  • Computer Skills: 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.).
  • Collaboration and Interpersonal Skills: 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).
  • Global Pharmacovigilance Standards: Knowledge of global pharmacovigilance standards and guidance documents.
  • Flexibility and Adaptability: Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
  • Strategic Planning and Organizational Skills: Excellent strategic planning, organizational and verbal and written communication skills.
  • Sound Judgment and Diplomacy: Ability to exercise sound judgment, tact, diplomacy and professionalism in all interactions. Highest level of scientific integrity.
  • Independence and Attention to Detail: Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
  • Travel Requirements: Able to travel ~25%, with international travel at times.
Preferred Qualifications
  • Degree: D. or PharmD degree, or other relevant Master's degree.
  • Medical Affairs Knowledge: Knowledge and proficiency related to Medical Affairs activities including registries.