Reports to: Vice President, Pharmaceutical Development

Leads and provides direct oversight for Supply Chain management at SCYNEXIS. Ensures a reliable market supply of the product manufactured by the Contract Manufacturing Organizations (CMOs) through transparent and accurate planning information, launch coordination (when applicable), label management, product change and transfer management. Provide proactive supply status of the product manufactured by the CMO. Provide robust and innovative supply chain solutions, supply issue facilitation, and collaboration to exceed expectations. This role will collaborate with Pharmaceutical Development, Regulatory, Quality, and other departments to meet all supply chain requirements.

At SCYNEXIS, we are committed to positively impacting the lives of patients suffering from difficult to treat and often life-threatening infections by developing innovative therapies We are seeking a talented and highly motivated individual for the role of Director, Manufacturing and Supply Chain Management. Join us and make a difference. 

Responsibilities:

• Create drug product demand based on clinical protocol requirements and commercial forecasts.
• Work actively and align with the Clinical Operations and Commercial team to create initial and continued supply plan for clinical and commercial drug product.
• Manage forecasting of clinical supplies as needed based on strategy changes (enrollment per country, number of sites per country, addition of new countries, etc.)
• Create IRT threshold levels and optimize as needed for efficient use of clinical supplies while avoiding supply risk at study sites. Adjust supply plan due to short dating or limited drug product availability.
• Lead label creation and approvals process, including translations for all countries, on assigned studies and programs
• Supports return and destruction of IMPs from sites to depots for assigned studies
• Responsible for inventory management which includes monitoring and optimizing inventory levels for all components of drug product including key raw materials and drug substance.
• Monitor regularly API and drug expiry. Manage temperature excursions during storage and transportation.
• Responsible for evaluation and selection of CMO’s meeting industry standards for excellence for packaging, labeling and distribution of clinical and commercial drug product
• Collaborate with internal commercial team and external CMO’s in designing key primary and secondary packaging activities for commercial drug product including material selection, packaging design, equipment and tooling design and qualification, labeling
• Plan, schedule and drive supply chain activities at CMO’s to expected timelines and desired deliverables.
• In collaboration with Quality Assurance, ensure that all activities are executed in compliance with global regulatory guidelines

Skills and Requirements:

• Bachelor's degree in a scientific field. Master’s degree preferred
• 15+ years of relevant industry experience with at least 5 years in supply management and demonstrable knowledge of the complete clinical supplies life cycle and commercial launch preferred
• Global logistics experience/understanding related to supply chains, import/export and drug depots, global trade compliance and regulations, and comparator or co-therapy product sourcing and project management
• Thorough knowledge of primary and secondary packaging materials and container closure systems for pharmaceutical drug products and their global regulatory requirements
• Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR),
• Strong understanding and application of validation processes (IQ/OQ/PQ/PV)
• Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical supply
• Ability to travel domestic and international as needed (Approximately 15%)
• Excellent interpersonal skills and problem solving/decision making skills
• Willingness to learn and sense of urgency to meet patient and program needs

SCYNEXIS is pioneering a new class of antifungal medicines to help millions of patients worldwide in need of new options to overcome and prevent difficult-to-treat and drug resistant infections. Our lead candidate, ibrexafungerp, is a broad-spectrum, intravenous (IV)/oral agent in late stage development for multiple indications, ranging from the treatment of vaginal yeast infections in the community setting to life-threatening invasive fungal infections in hospitalized patients. Our passion for the patient is the core foundation of our company and we use our resourceful mindset to drive our efficiency.  We believe that our differences make us stronger and our flexibility allows us to quickly adjust to opportunities. We are seeking a talented and highly motivated leader for the role of Executive Director, Market Access. We are committed to positively impacting the lives of patients by developing innovative therapies, come join us and make a difference.

Position Summary

The Executive Director, Market Access will be responsible for all development and direction of all market access activities, including strategy, value proposition, pricing, value proposition, contracting, and pharmacy network. This person will lead a team with an initial goal of achieving favorable market access with minimal restrictions for the company’s first product launch. The position will have supervisory responsibility for payer marketers, agency management, and budget management. The selected individual will also build and hire a field-based managed markets team. This position is based in Jersey City, NJ with flexibility for remote work when required. This role reports to the Chief Commercial Officer (CCO) and is a member of the senior commercial leadership team.

Key Responsibilities
Strategy Development & Implementation

• In partnership with the CCO, develop market access strategies in line with Company sales goals, customer needs and in alignment with Sales, Marketing, Medical and other functions
• In partnership with the CCO, develop clear and compelling product value proposition and any needed HEOR analyses, based on available evidence and objective methodologies for company products at all stages of the product life cycle
• Build U.S. pricing strategy, (rebating and contracting strategy if/when necessary) to maximize sales while meeting customer needs and ensuring consistency of implementation to optimize GtN
• Recommend U.S. pharmacy network strategy; build and manage a network supporting that strategy to enhance competitive offerings aligned to product strategy
• Apply significant strategic and commercial insights to inform and drive product strategy, commercial launch strategy and tactical execution

People Management

• Build and lead a US managed markets team, covering primarily commercial plans and pharmacy distribution
• Hire and manage a Payer Marketer, who will be responsible for development of all Payer Marketing strategies and tactical implementation, including research, materials, tools and related systems
• Set team goals and objectives, provide clear and concise direction and appropriate level of support, developing team skill sets to continuously improve performance and support career progression

Customer Management

• Create and implement contract strategies designed to ensure access & reimbursement with key accounts
• Build senior level relationships and develop deep understanding of strategic customers organization, structure, needs, perspective, issues, business strategy and priorities; lead negotiations with top accounts

Launch Preparation

• Work closely with cross-functional leadership to effectively prepare organization for product launches
• Ensure appropriate account resourcing is available for both pre-launch and post-launch success
• Advise management on key U.S. access policies and reimbursement practices affecting corporate objectives, quantify risks and opportunities and make recommendations for action
• Provide insights to clinical development teams to ensure adequate market access and health economic outcomes-related input in clinical trials and other evidence generation activities
• Integrate with the brand marketing team in connection with economic patient support programs such as co-pay cards
• Manage oversight and governance of agencies, vendors and manage assigned budget to accomplish all required tasks
• Liaison with Legal / Regulatory / Compliance to ensure all materials, processes and systems meet legal and compliance requirements

Qualifications

• Bachelor’s degree (business discipline preferred); Master’s degree preferred
• 10 or more years of pharmaceutical / biotech experience, with 5 or more years in Market Access
• Experienced individual with track record of leadership in pharma/biotech, experience in healthcare contracting, contract operations, government price reporting, PBM/National Health Plan business
• Demonstrated ability to impact payer perceptions, establish unmet needs and the use of surrogate endpoints
• Experience in working with reimbursement and access issues for Women’s health (required) and Hospital Infections (preferred).

Required Skills:

• Ability to view issues from multiple functional perspectives while managing organizational ambiguity
• Proven ability to navigate complex customers and build relationships across key stakeholders
• Strong strategic, analytical, time and priority management abilities
• Proven expertise in cross-functional collaboration and teamwork
• Possess excellent written and oral communication skills
• Demonstrated leadership, people management and team-building skills
• Exhibits a drive for results, sense of urgency and solution-oriented approach
• Leads with enthusiasm and passion for work, kindness and empathy