If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the Global Head of Regulatory Affairs your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.

As the Global Head of Regulatory Affairs working on the Global Regulatory Affairs team you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.

Principle Responsibilities:

• Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. Ensures compliance for global regulatory requirements.
• Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors.
• Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor.
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
• Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.
• Oversees all submissions.
• Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary.
• Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Qualifications and Education Requirements:

• MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
• Proven success in regulatory submissions.
• FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines.
• Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
• Experience with investigational drugs, including late stage development, and marketed products
• CRO management experience preferred.
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
• Must be a strong leader that creates a vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
• Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Strategic thinker, planner, and implementer with excellent organizational skills.
• Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents.
• Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes.
• Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and within global teams.
• Independent thought, negotiation skills, integrity, and adaptability.
• Ability to work on own and in virtual setting.
• MS Office skills with excellent use of excel, PowerPoint and MS Project required.
• Recent experience with a smaller entrepreneurial environment is a definite asset.
• Fluent in English (written and oral).

#LI-Hybrid

Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities.  The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

 Principle Responsibilities:

• Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
• Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
• Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
• Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
• Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
• Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
• Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports

CORE Responsibilities

• Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
• Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
• Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
• Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
• Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
• Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
• Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
• Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
• Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements

• 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
• Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
• Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
• Bachelor’s degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

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Brief team/department description:

As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies.  The person will play crucial role in managing lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.

Principle Responsibilities:

• Provide regulatory assistance with due diligence requests to support new business development activities.
• Support interaction with FDA and other regulatory agencies for assigned commercial products.
• Assist in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post marketing supplements for assigned products.
• Manage the timelines associated with regulatory submissions such as post-marketing periodic reports.
• Manage archival of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms.
• Provide regulatory guidance on requirements for post-approval changes, as required, for assigned products.
• Review and provide regulatory assessments for change control documentation.
• Provide regulatory support to regulatory leadership meetings and presentations.
• Keep abreast of current regulations and regulatory guidance, assessing impact to assigned products and internal processes.
• Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
• Other duties as assigned.

Qualifications and Education Requirements

• Minimum of Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
• Minimum of 3 years in the pharmaceutical industry with at least 1 of those years in regulatory affairs.
• Combination of education and applicable job experience may be considered.
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.​
• Ability to work independently with minimal supervision in a fast-paced deadline driven environment​.
• Keen attention to detail.
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met​.
• Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.

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Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities.  The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

 Principle Responsibilities:

• Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
• Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
• Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
• Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
• Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
• Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
• Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports

CORE Responsibilities

• Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
• Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
• Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
• Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
• Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
• Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
• Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
• Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
• Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements

• 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
• Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
• Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
• Bachelor’s degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

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About the Role

Role Summary

The Director, US Controller provides senior‑level oversight of US accounting, financial reporting, and Gross‑to‑Net (GTN) accounting, delivered through a Global Capability Center (GCC). This role is accountable for the quality, accuracy, and GAAP compliance of the US close, while day‑to‑day execution is performed by the GCC.

The Director serves as the primary US accounting authority, owning accounting policy, technical judgment, review, and audit interaction. The role partners closely with Commercial, FP&A, Contracting, and External Auditors to ensure reliable, decision‑ready financials in a GTN‑intensive commercial environment.

Key Responsibilities

US Close & Financial Reporting Oversight

• Provide overall governance and oversight of the US monthly, quarterly, and annual close executed by the GCC.
• Own the close calendar, review framework, and escalation process.
• Review and approve all material journal entries, estimates, and balance sheet reconciliations.
• Ensure timely delivery of accurate US GAAP financial statements and management reporting.
• Serve as final accounting approver prior to submission to senior leadership and auditors.

Gross‑to‑Net Accounting Leadership

• Own GTN accounting policy, methodology, and estimation framework.
• Review and challenge GTN reserve calculations prepared by the GCC, including:
• Chargebacks
• Commercial and government rebates
• Returns and return reserves
• Admin/service fees, distribution fees, prompt pay, and other deductions
• Apply accounting judgment to assumptions, lag analysis, utilization trends, and true‑ups.
• Partner with Commercial, Managed Markets, and Contracting teams to ensure GTN accounting reflects contractual reality.
• Explain GTN movements, risks, and volatility drivers to FP&A and senior finance leadership.

GCC Governance & Quality Control

• Act as the primary onshore accounting oversight lead for the GCC‑supported US close.
• Define clear roles, review standards, and documentation expectations.
• Conduct structured reviews of GCC output to ensure consistency, accuracy, and GAAP compliance.
• Identify quality or control issues and work with GCC leadership to remediate.
• Escalate and resolve complex accounting matters requiring onshore judgment.

Controls, Audit & Policy

• Own US accounting policies, technical memos, and key accounting judgments.
• Ensure GCC‑executed processes are well‑documented, controlled, and audit‑ready.
• Serve as the primary US accounting contact for external auditors.
• Lead audit planning, walkthroughs, technical discussions, and issue resolution.

Required Qualifications

• Bachelor’s degree in Accounting or Finance; CPA.
• 12+ years of progressive accounting experience, including Controller or Director‑level roles.
• Deep Gross‑to‑Net accounting experience, ideally in pharma or life sciences.
• Experience operating within a GCC or offshore‑supported accounting model.
• Strong US GAAP knowledge with demonstrated judgment in revenue, estimates, and reserves.
• Proven strength in review, governance, and stakeholder management rather than transaction execution.

Leadership Profile

• Senior accounting reviewer and technical authority
• Comfortable challenging assumptions and outputs
• Clear communicator with executives and auditors
• Strong governance and quality mindset
• Effective influencer across onshore and offshore teams

What Success Looks Like

• Consistent, high‑quality US close delivered through the GCC
• Defensible, explainable GTN reserves with minimal surprises
• Smooth audits with strong documentation and limited rework
• High trust from Commercial, FP&A, and Finance leadership

#LI-Hybrid
#LI-Full-time

If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the Global Head of Regulatory Affairs your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.

As the Global Head of Regulatory Affairs working on the Global Regulatory Affairs team you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.

Principle Responsibilities:

• Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. Ensures compliance for global regulatory requirements.
• Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors.
• Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor.
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
• Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.
• Oversees all submissions.
• Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary.
• Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Qualifications and Education Requirements:

• MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
• Proven success in regulatory submissions.
• FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines.
• Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
• Experience with investigational drugs, including late stage development, and marketed products
• CRO management experience preferred.
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
• Must be a strong leader that creates a vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
• Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Strategic thinker, planner, and implementer with excellent organizational skills.
• Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents.
• Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes.
• Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and within global teams.
• Independent thought, negotiation skills, integrity, and adaptability.
• Ability to work on own and in virtual setting.
• MS Office skills with excellent use of excel, PowerPoint and MS Project required.
• Recent experience with a smaller entrepreneurial environment is a definite asset.
• Fluent in English (written and oral).

#LI-Hybrid

Brief team/department description:

The Director of Franchise Portfolio Management at Azurity plays a crucial role in strategy development, management, and execution for the franchise product portfolio, supporting the VP of Franchise Portfolio Management.

Principle Responsibilities:

• Gain a strong expertise in the therapy areas overseen by the franchise through targeted research, competitive intelligence, engagement with market and customer insights, and attendance at key conferences.
• Contribute to franchise-level strategic plans, including mature asset management and revenue optimization.
• Drive brand strategy development and execution through each Product Lifecycle Management (PLM) stage, ensuring readiness for launch.
• Manage brand plans, pricing strategies, forecasts and forecast assumptions, target product profiles (TPPs), and P&Ls over the life of products/brands managed by the franchise. Guide launch archetype development and post-launch enhancements, including line extensions and phase-outs.
• Continuously gather and analyze customer insights to refine product and commercial strategies.
• Oversee product enhancements and line extensions after market introduction, and plan for phase-outs and support withdrawal as products reach end-of-life.
• Support Product Lifecycle Management (PLM) process through all stages under the guidance of VP Franchise Portfolio Management, and coordinate with relevant cross-functional teams to meet stage-gate criteria and timelines and recommend product discontinuations when needed.
• Assist in preparing reports, presentations, and recommendations for portfolio reviews and strategic planning sessions.
• Work with the corporate development team to identify, evaluate, and integrate external assets that enhance the internal portfolio and strengthen product offerings.

Qualifications and Education Requirements

• PharmD or PhD or bachelor’s or master’s degree in a relevant field (e.g., Life Sciences, Business Administration) preferred.
• 5+ years of relevant experience with an advanced degree; 10+ years with a bachelor’s degree
• Experience in pipeline or in-line marketing or new products commercialization
• Familiarity with therapeutic areas and pharmaceutical drug development and commercialization.
• Experience conducting primary and secondary market research and developing, discussion guides, target product profiles (TPPs), forecast assumptions for new product ideas.
• Experience in sales forecasting and financial modeling.
• Knowledge of pharmaceutical product lifecycle management and commercialization processes.
• Detail-oriented with strong organizational skills, capable of managing multiple tasks and priorities.

#LI-Hybrid
#LI-Full-time

Franchises Supported: CORE and ARGO

Level: Director

Role Summary

The Director, Franchise Program Management – CORE & ARGO is a franchise‑anchored leadership role responsible for stewarding Azurity’s Product Lifecycle Management (PLM) process and Management System across the CORE and ARGO franchises. The role ensures disciplined execution, cross‑functional accountability, and effective governance from early ideation through launch, lifecycle management, and value realization.

This role operates as a trusted integrator and enablement leader—partnering closely with Franchise Portfolio Management (FPM), Medical, Clinical, Regulatory, Commercial, CMC, Finance, and Operations leaders to ensure that franchise priorities are translated into clear plans, aligned execution, and decision‑ready governance. The Director does not own product strategy or functional execution, but is accountable for ensuring that the PLM system works predictably, transparently, and at enterprise standard.

Key Responsibilities

Product Lifecycle Management (PLM) Stewardship

• Serve as the primary steward of the PLM process for CORE and ARGO assets across all lifecycle stages (cradle to grave)
• Ensure consistent application of PLM stages, stage‑gate criteria, and governance expectations
• Maintain clear visibility into asset status, readiness, risks, and upcoming decision points
• Identify gaps or deviations from PLM expectations and drive corrective action

Accountability & Execution Enablement

• Establish and maintain clear cross‑functional ownership, milestones, and deliverables for franchise assets
• Track progress, risks, dependencies, and interlocks across asset teams
• Hold peers accountable to commitments through disciplined follow‑up and escalation, without owning functional execution
• Surface issues early and frame options to support timely leadership decisions

Cross‑Functional Collaboration & Integration

• Act as the connective tissue across Medical, Clinical, Regulatory, Commercial, CMC, Supply Chain, Finance, and Operations
• Facilitate effective cross‑functional discussions that drive alignment and resolve ambiguity
• Ensure functional inputs are integrated into a cohesive franchise‑level execution view
• Promote enterprise‑first thinking over functional optimization

Governance & Decision Readiness

• Prepare asset teams for PLM stage‑gates, franchise governance, and executive reviews
• Ensure materials are complete, aligned, and decision‑ready
• Confirm that recommendations clearly articulate risks, trade‑offs, and implications
• Determine readiness to advance assets through governance forums

Management System & A3 Leadership

• Act as a visible advocate and steward of Azurity’s Management System within CORE and ARGO
• Ensure appropriate use of A3s to manage priorities, risks, and complex cross‑functional problems
• Coach asset teams on structured problem‑solving, transparency, and disciplined execution
• Drive continuous improvement in PLM and franchise ways of working

Business Development & Integration Support

• Partner with Business Development and FPM to support diligence activities for CORE and ARGO assets
• Coordinate cross‑functional inputs during diligence using Management System principles
• Support integration planning and transition of new assets into the PLM framework

Qualifications

• Demonstrated success leading cross‑functional program or portfolio management in pharmaceutical or biotechnology environments
• Strong understanding of product lifecycle management, stage‑gate governance, and launch readiness
• Proven ability to lead through influence and hold peers accountable without direct authority
• Experience operating in matrixed organizations with multiple stakeholders and priorities
• Excellent executive communication, facilitation, and issue‑framing skills
• Comfort navigating ambiguity, trade‑offs, and complex decision environments

Success Profile

The successful candidate is recognized as a calm, credible franchise integrator who brings clarity and discipline to complex work. They enable leaders to make timely, well‑informed decisions, ensure that the PLM system is trusted and predictable, and create an environment where cross‑functional teams collaborate effectively and execute with accountability.

#LI-Hybrid
#LI-Full-time

Brief team/department description:

The Director of Franchise Portfolio Management at Azurity plays a crucial role in strategy development, management, and execution for the franchise product portfolio, supporting the VP of Franchise Portfolio Management.

Principle Responsibilities:

• Gain a strong expertise in the therapy areas overseen by the franchise through targeted research, competitive intelligence, engagement with market and customer insights, and attendance at key conferences.
• Contribute to franchise-level strategic plans, including mature asset management and revenue optimization.
• Drive brand strategy development and execution through each Product Lifecycle Management (PLM) stage, ensuring readiness for launch.
• Manage brand plans, pricing strategies, forecasts and forecast assumptions, target product profiles (TPPs), and P&Ls over the life of products/brands managed by the franchise. Guide launch archetype development and post-launch enhancements, including line extensions and phase-outs.
• Continuously gather and analyze customer insights to refine product and commercial strategies.
• Oversee product enhancements and line extensions after market introduction, and plan for phase-outs and support withdrawal as products reach end-of-life.
• Support Product Lifecycle Management (PLM) process through all stages under the guidance of VP Franchise Portfolio Management, and coordinate with relevant cross-functional teams to meet stage-gate criteria and timelines and recommend product discontinuations when needed.
• Assist in preparing reports, presentations, and recommendations for portfolio reviews and strategic planning sessions.
• Work with the corporate development team to identify, evaluate, and integrate external assets that enhance the internal portfolio and strengthen product offerings.

Qualifications and Education Requirements

• PharmD or PhD or bachelor’s or master’s degree in a relevant field (e.g., Life Sciences, Business Administration) preferred.
• 5+ years of relevant experience with an advanced degree; 10+ years with a bachelor’s degree
• Experience in pipeline or in-line marketing or new products commercialization
• Familiarity with therapeutic areas and pharmaceutical drug development and commercialization.
• Experience conducting primary and secondary market research and developing, discussion guides, target product profiles (TPPs), forecast assumptions for new product ideas.
• Experience in sales forecasting and financial modeling.
• Knowledge of pharmaceutical product lifecycle management and commercialization processes.
• Detail-oriented with strong organizational skills, capable of managing multiple tasks and priorities.

CRITICAL LEADERSHIP CAPABILITIES

• Provides effective support and coordination within cross-functional teams.
• Make informed decisions and manage resources effectively within the scope of the role.
• Communicate effectively with both technical and commercial stakeholders, supporting alignment and execution of strategic goals.

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