Director, Global Portfolio New Product Concepts

Job Summary

The Director Global Portfolio New Product Concepts plays a critical role in shaping cross-functional decisions for Apotexs global pharmaceutical portfolio. This position bridges new portfolio concepts with clinical research and regulatory strategies ensuring alignment and value realization throughout the product lifecycle. Key responsibilities include:

Portfolio Strategy & Alignment: Collaborate with Senior Directors to develop and manage processes that connect new product concepts to the best product strategy for the marketincluding those from Business Development so we are comparing the available idea to best in class. This includes understand costs and risks related to development clinical and regulatory strategies. The role will require creation of a strong methodology for explaining the concept across the relevant teams.

• Technology Assessment: Determine the best product approach for Apotex which includes incorporating new technologies under consideration while enabling rapid alignment across development clinical and regulatory teams.
• Risk & Opportunity Analysis: Transform product strategy concepts into usable data so upside and risk scenarios can be created for use in data review and stakeholder discussions.
• Innovation Leadership: Drive the introduction of new technologies and devices into product strategies to create valuable market entries for both generic and branded portfolios. Watch disease trends and new brands to proactively introduct new products in a timely manner.
• Research Oversight: Ensure internal and external research teams remain aligned with strategic objectives defining measurable targets and maintaining good communication with the Project Management Office.
• Market & Regulatory Research: Analyze market comparators and regulatory pathways (e.g. 505(b)(2) approaches label changes) to minimize approval risks and maximize market value.
• Global Compliance: Understand country-specific requirements (U.S. Canada Mexico Saudi Arabia etc.) and engage third-party experts as needed.
• Competitive Intelligence: Provide feedback on competitor challenges and market dynamics to inform strategic decisions.
• Cross-Functional Collaboration: Build relationships across Apotex to ensure technical alignment timing and development strategies for in-house products supporting successful launches and lifecycle management.

This position will be responsible for working with others in Global Portfolio and Corporate Development to make sure projects maintain the appropriate pipeline metrics:

• Financially: IRR NPV minimum hurdle rates etc
• Legal: Intellectual Property (from a brand creation and generic perspective)
• RnD spend rationalization risk rates etc.

All of the above require scientific knowledge and pharmaceutical market dynamics this role ensures alignment across the technical development side of the project including manufacturing while serving as a key strategist in portfolio expansion.

Job Responsibilities

• Oversee the creation of new product concepts (505b2s) particularly related to clinical and regulatory opportunities as ways to get to the market with better products for patients.
• Confirm project budgets are appropriate including any needed CRO spend and filing strategies on ANDAs vs. 505b2s in US or as required in other countries.
• Utilize the appropriate technology and devices and setting up required studies via cross-functional group discussions to make sure all costs are appropriately incorporated in the project up-front before it is funded.
• Coordinate improved processes for new products working with project management as necessary to make sure the products have the appropriate timelines and milestones.
• Coordination with regulatory to create strong pre-IND meetings including literature clinical plans including the use of AI supported pK comparisons from on-market products using companies like Insight RX etc.
• Alignment with Key Opinion Leaders on specific topics to help support white papers pre-IND support as needed
• Cultivate strong relationships with key stakeholders in partner organizations.
• Ensures compliance with all Company policies and procedures including safety rules and regulations.
• Operates in accordance with our Code of Conduct and Business Ethics and all established regulatory compliance and safety requirements
• Performs all work in support of our Values: Collaboration Courage Perseverance and Passion

All other relevant duties as assigned.

Job Requirements

• Degree in Health Sciences Masters degrees preferred and at least 10 years leadership experience in a regulatory clinical research or a portfolio mgmt role
• 10 years experience in the pharmaceutical/biotech environment
• Ability to get work done through others via cross-functional relationships
• Exceptional oral and written communication skills
• Demonstrated record of increasing responsibility
• Exceptional interpersonal skills
• Willing to take initiative and work with limited direction

This job posting is for a role that is currently available and vacant at Apotex.

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