Hybrid Sr. Director, CMC

at Allucent

• Job title: Sr. Director, CMC
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Montreal, Canada

About the role

• Senior Director, CMC at Allucent leading end-to-end CMC strategy for biopharmaceutical development. Responsible for regulatory excellence and managing direct reports in a hybrid work setting.

Responsibilities

• Lead the end-to-end CMC strategy for drug substances, drug products, and analytical development, from early assessment through regulatory submission and commercial launch, with a focus on scientific aspects.
• Promote regulatory excellence by authoring and reviewing CMC dossiers, managing communications with health authorities, and ensuring compliance with FDA, EMA, and ICH guidelines.
• Prepare product development plans, from early development through Phase 4.
• Manage and lead direct reports through development and performance management, and provide training on current and new regulatory requirements.
• Perform other scientific duties as needed.

Requirements

• Bachelor's degree, PharmD, Master's degree, PhD or equivalent in a scientific field, with equivalent professional experience in drug, biologic, or medical device development.
• Advanced scientific and regulatory knowledge in drug, biologic, or medical device development.
• Experience with products in the pre-approval stage; strong experience with biologics is required.
• Experience managing teams is required.
• Prior experience in a CRO is an asset.
• Critical thinking and analytical skills, financial acumen, ability to influence and lead teams, risk assessment skills, and excellent written and verbal communication skills in English.
• Strong computer skills, including SharePoint, Word, Excel, and PowerPoint.
• Quality-focused.
• High emotional intelligence, customer-focused leadership, and strong decision-making abilities.
• Innovative, creative, and pragmatic mindset, including problem-solving skills.
• >10 years of directly relevant post-degree experience in drug, biologic, or medical device development preferred.

Benefits

• Comprehensive benefits package per site
• Competitive salaries per site
• Departmental budget for studies/training to support professional development
• Flexible working hours (where reasonably practicable)
• Option to work remotely/in a hybrid model depending on the site
• Leadership and mentoring opportunities
• Participation in our sponsorship program as a new or existing employee
• Opportunities for internal mobility and career progression
• Financially attractive internal employee referral program