Sr Director - Global Portfolio, New Product Concepts

Job Summary

The Sr Director, Global Portfolio, New Product Concepts plays a pivotal role in shaping the cross-functional decisions surrounding Apotex's global pharmaceutical portfolio. The Sr Director will be responsible for creating and managing processes that connects the portfolio concepts to research,  technologies and devices to create winning market entries for a generic and branded portfolio. The process oversight will ensure that the research team, internal or external stay on strategy, to best realize the value of the product. 

The Sr Director of New Product Concepts will also be responsible for creating the product background, working with countries to develop forecasts that represent the new product.  At times it may be necessary for the Sr Director to work with countries to run market research to better build out the details of the product and market dynamic.  The Sr Director will determine the best development strategy for the concept,  including in-licensing, or acquisition of an asset that is improved on to drive the best revenue and profit growth.

The Sr Director will work with others across the Apotex organization to create the needed relationships to act on the necessary products that are moving in-house and work with them on a technical level, in order to confirm alignment on timing and development strategy so the product is delivered as required and value is maintained through the launch of the product, including life-cycle management.

The Sr. Director will work 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), Hatch Waxman (FTF, Day 181, forfeiture, etc. other rules), etc.    
• Plant maximization, including when working with CMOs, standard cost of good averages across dosage forms, etc.
• 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 and development plans of new product concepts, particularly 505b2 and expanded brand strategy opportunities. Confirm project budgets are appropriate, including any needed CRO spend and filing fees.
• Utilize deep knowledge to align with appropriate technology and device partners to assure delivery of the new products (including contract strategy)– prior experience with developing new devices and combination products required, including setting up human factor studies
• Coordinate improved processes for new products, working with research and 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
• Develop compelling narratives around pharmaceutical products, articulating their value and positioning in the market, especially when looking at alternate drug options for molecules outside of standard ANDA routes.
• 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

• Bachelor’s degree in Engineering or Science, Masters degrees preferred and at least 20 years’ leadership experience in a Research, Portfolio Mgmt or Manufacturing role
• 15+ years’ experience in the pharmaceutical/biotech environment
• Ability to get work done through others, via cross-functional relationships
• Experience in leading (supervising, directing, coaching, developing) direct reports
• Demonstrated record of increasing responsibility
• Exceptional interpersonal skills
• Exceptional oral and written communication skills
• Willing to take initiative and work with limited direction