Senior Clinical Development Manager

4 weeks ago

Markham, Ontario, Canada Astellas Pharma Inc. Full time

Overview

Astellas Pharma Inc. is a leading pharmaceutical company seeking a highly skilled Senior Clinical Development Manager to join our team.

**Estimated Salary:** $150,000 - $180,000 per year

About the Job

The Senior Clinical Development Manager will be responsible for overseeing clinical trials and development programs, working closely with cross-functional teams to ensure timely and successful project delivery. This role requires strong leadership skills, expertise in clinical drug development, and excellent communication abilities.

Key Responsibilities:

  • Develop and execute clinical trial strategies, protocols, and study plans.
  • Lead cross-functional teams, including Medical Affairs, Clinical Operations, and Data Sciences, to achieve project goals.
  • Collaborate with Health Authorities, Investigators, and Key External Experts to facilitate clinical trial conduct and regulatory submissions.
  • Maintain up-to-date knowledge of global pharmacovigilance standards and guidance documents.
  • Ensure compliance with regulatory requirements and Astellas' internal policies.
  • Identify and mitigate risks associated with clinical trials and development programs.
  • Serve as a key partner for Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies.

Requirements:

  • Advanced degree in a relevant scientific discipline (health science or clinical discipline) with typically 7-10 years of clinical, scientific/research, pathology, or industry-related experience.
  • Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development from initial study design to regulatory submissions.
  • Strong computer skills, including MS Office Suite and industry-standard software (e.g., electronic data capture systems).
  • Excellent collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas.
  • Demonstrated success working with key external stakeholders, including presenting/responding to health authorities.
  • Ability to exercise sound judgment, tact, diplomacy, and professionalism in all interactions.
  • Able to travel approximately 25%, with international travel at times.

Benefits:

  • Medical, Dental, and Vision Insurance
  • Generous Paid Time Off options, including Vacation, Sick time, national holidays, 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

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