Clinical Operations Development Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for the management of clinical activities within a designated therapeutic area for a specific asset.

• Co-directs the Clinical Development Team (CDT) and shares responsibility for the Clinical Development Plan (CDP).

• Ensures that all pertinent information from various functions within the AST and CDT is effectively communicated.

• Responsible for formulating the clinical development strategy and ensuring the execution of the CDP once it has been approved by the AST.

• Manages the clinical trial budgets, contributes to the timeline and resource requirements, and provides insights for the financial planning of the CDT.

• Collaborates with the PM to evaluate the status and implications of changes, discussing potential solutions to address issues and mitigate risks.

⛳️ Requirements

• Bachelor’s degree or equivalent university qualification in a medical or para-medical field (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or comparable experience.

• A minimum of 10 years of leadership experience in Clinical Development, including monitoring and management of local and global/international trials.

• Demonstrated experience in Clinical Operations in a significant global leadership role within the pharmaceutical or biotech sector.

• Excellent interpersonal skills and stakeholder management capabilities.

• Experience working within an outsourced model, including management of CROs and vendors.

• Background in rare diseases and/or autoimmune clinical trials is an advantage.

• Proficient verbal and written communication skills in English (primary fluency or full professional proficiency).

🏝️ Benefits

• Health benefits

• Retirement savings plans

• Short-term and long-term incentive programs