Senior Clinical Development Manager

3 weeks ago

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

About the Role:

Astellas Pharma Inc. is seeking a highly skilled Senior Clinical Development Manager to join our team. In this role, you will be responsible for leading clinical development activities for assigned programs, collaborating with cross-functional teams, and ensuring timely delivery of high-quality results.

Key Responsibilities:

  • Develop and execute clinical development plans, protocols, and study reports in collaboration with medical affairs, regulatory, and data sciences teams.
  • Provide expertise to internal stakeholders on clinical drug development, including study design, execution, and regulatory submissions.
  • Serve as key partner for development division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies.
  • Represent Astellas in health authority meetings and address inquiries.
  • Collaborate with GML in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
  • Partners with Clinical Operations and Medical Affairs in enabling appropriate enrollment into the clinical studies or registries.

Requirements:

  • 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).
  • 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 and industry-standard software (e.g. electronic data capture systems).
  • Excellent strategic planning, organizational and verbal and written communication skills.
  • Ability to exercise sound judgment, tact, diplomacy and professionalism in all interactions.

Benefits:

  • Estimated salary: $120,000 - $180,000 per year.
  • Medical, Dental and Vision Insurance.
  • Generous Paid Time Off options.
  • Country Specific Retirement Savings Plan.
  • Company paid life insurance.
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions.
  • Long Term Incentive Plan for eligible positions.
  • Referral bonus program.

Location: This position is based in [insert location] and requires approximately 25% travel.

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