Description

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

• Recruit, hire, train and manage a leadership team of Field Access Managers to support HCP staff on insurance coverage and reimbursement policies for current and potential new products
• Create a high-performance team driven by common values of trust, respect and commitment in winning the right way (culture of compliance)
• Establish a strong vision and clear objectives for the Field Access Management department that aligns with Ardelyx’s values
• Conduct performance evaluations, mentor, develop and lead a diverse and talented leadership team who are competent and skilled in the healthcare marketplace and in access and reimbursement
• Collaborate with Field Sales, Market Access, and Patient Support Services leadership to proactively identify, prioritize and address patient access trends
• Provide strategic direction to Field Access Management leaders
• Ensure adherence to all corporate and industry policies, following training provided by Ardelyx's Commercial, Legal, Regulatory, and Compliance. Implement quality assurance processes to uphold high service delivery standards 
• Achieve annual key objectives and demonstrate accountability for execution, driving results and performance 
• Monitor and assess program effectiveness, implementing data-driven improvements as necessary to enhance outcomes 
• Ensure adherence to all corporate and industry policies, following training provided by Ironwood's Commercial, Legal, Regulatory, and Compliance. Implement quality assurance processes to uphold high service delivery standards. 
• Optimize resource allocation to maximize the impact and efficiency of field access support 
• Manage program analytics and metrics via dashboards/reports to maintain program transparency, identify trends, measure program success, and support strategic decision-making for the Field Access Management functions 

• Bachelor’s degree with 10-12 years of commercial experience in the pharmaceutical or biotech industry or 12+ years of total healthcare experience, including field access and reimbursement. Other experience that will be considered market access, payer marketing, patient support programs, clinical and/or sales experience
• 5+ years leadership experience demonstrating ability to build and sustain compliant, high performing teams
• Experience in recruiting and hiring high-performing teams required
• Experience leading a field access team preferred
• Leadership product launch experience required
• Excellent understanding of prescription patient journey, drug coverage/benefit design, and reimbursement process
• Demonstrated strength in strategic planning and tactical plan development and execution
• Attention to detail, self-motivated with a sense of urgency
• Creative problem solver
• Demonstrated leadership and leading high-performance teams; can persuade and influence others; manage conflict appropriately
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
• Excellent written and verbal communication skills
• Ability to travel up to 40% of the time as needed

• Remote with regular travel to Ardelyx corporate offices.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.

Description

• Work collaboratively and cross-functionally with internal stakeholders on evaluating and analyzing various strategic business development projects, including acquisitions, licenses, and collaborations.
• Coordinate and execute cross-functional due diligence processes, including the management of virtual data rooms.
• Take ownership of generating financial deal models to support business development objectives.
• Prepare high-quality presentation materials for senior leaders and key stakeholders as business development opportunities are advanced through the internal deal governance process.
• Assist in prospecting new business development opportunities and lead the management and tracking of current and historical business development engagements.
• Actively monitor industry trends and strive to make continuous improvements to the deal management process.

• Bachelor's degree in business, finance, or a related field.
• 1-3 years of transaction experience in corporate development, business development, investment banking, or consulting, preferably in the biopharmaceutical industry.
• Proficient knowledge of accounting, finance, and valuation, with demonstrated experience in building complex financial models using Excel, including deep knowledge of formulas, charts, and pivot tables.
• Strong verbal and written communication skills, with the ability to present complex data and insights clearly in effective, concise reports and presentations.

Description

• With oversight, develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes writing, interpreting, and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines. 
• Write, format, and edit clear, concise content that meets the target audience's needs, adhering to style guidelines and documentation standards. 
• Clinical documents may include investigator brochures,standard response documents (SRDs), FAQs, protocols, clinical study reports, integrated reports, clinical sections of core technical documents/new drug applications/briefing documents per regulations, manuscripts/abstracts for publication and/or presentation. 
• Ensure compliance of clinical documents with regulatory requirements. 
• Provide scientific evaluation of company products to key internal stakeholders, and collaborate with cross-functional teams to implement medical-driven communication strategies. 

• Act as a scientific point of contact within the company, facilitating clear and effective communication of scientific information. 

• Prepare document timelines, with guidance from manager, as needed. 
• Conduct literature searches. 
• Summarize data from statistical tables and other sources as needed. 
• Coordinate quality control reviews of clinical documents and maintain audit trails of changes. 

• Review and ensure the accuracy, clarity, and consistency of all clinical documents. 

• Advanced degree in a scientific discipline (PhD, PharmD, MD) preferred; Master’s degree with significant relevant experience considered. 

• Minimum of 3-5 years of medical writing experience in the pharmaceutical or biotechnology industry, with a strong understanding of regulatory submission requirements.
• Exceptional writing, editing, and formatting skills.
• Detail-oriented with a focus on accuracy and precision. 
• Ability to interpret and summarize complex scientific data. 

• Excellent communication and interpersonal skills. 
• Proven ability to manage multiple projects and meet deadlines. 
• Strong organizational and project management skills.
• Ability to work independently and as part of a team. 

• Remote position with up to 15% travel to meetings throughout the year. 

Description

• A key component of this role is to establish collaborative relationships with Patient Services Program Partners, Field Sales, and Healthcare Providers to support patient access. Additional responsibilities will include, but not necessarily limited to, the following:
• Partner with internal and external stakeholders to identify, anticipate and address patient and HCP access barriers; Implement updates/changes based on solutions generated to address barriers
• Educate HCPs on access solutions for core and launch products
• Collaborate with key team members such as Patient Services partners, Field Sales, and other internal stakeholders to serve as access and reimbursement expert for assigned geographies
• Build strong, trust-based relationships with HCPs, Field Sales, and Patient Services partners
• Create and maintain business plans to deliver effective geography-based updates to Field Sales 
• Monitor patient start trends in assigned geographies/plans, and collaborate with Field Sales and Patient Services partners to proactively address and mitigate challenges
• Maintain and grow knowledge of national, regional, local, and account market dynamics for payors and prescribers
• Grow the knowledge of hub and specialty distribution channels to understand current policies, potential future changes, and improve patient support needs
• Collaborate with internal departments such as marketing, market access, field sales, patient services, to support patient drug accessibility
• Serve as subject matter expert regarding education and insights on access and affordability solutions across multiple payer types and plans (i.e., Medicare, Medicaid Managed Care, Commercial)
• Execute business in accordance with the highest ethical, legal, and compliance standards, including timely and successful completion of all required training 
• Remains current on and anticipates changes in product coverage and access knowledge, marketplace conditions, and stakeholder practices to deliver the most effective delivery of approved materials 
• Understands and adapts to the changing healthcare ecosystem to customize resourcing and messaging to HCPs and HCP staff

• A minimum of a B.A/B.S. required; Advanced degree within business or healthcare preferred.
• 5-8 years of experience within public or private reimbursement services, healthcare operations, and/or sales. Other backgrounds with related experience in market access, or healthcare will be considered. Pharmaceutical industry experience strongly preferred.
• Extensive knowledge of medication access channels.
• Strong functional knowledge of specialty pharmacy and health insurance and benefits (i.e. Medicare Part D, commercial and Medicaid) with a demonstrated expert understanding of insurance eligibility, benefit verification, prior authorization processes, reimbursement coverage, appealing insurance denials, application of financial assistance, co-pay support and free product programs
• Knowledge of HCP office processes regarding patient flow, prescription flow and clinic office operations. Direct experience with GI or Nephrology products or providers preferred.
• Outstanding customer relationship, interpersonal, and communication skills with the established ability to effectively work with diverse audiences and influence cross-functionally.
• Ability to master product information to effectively represent product access and information to customers.
• Ability to evaluate data and identify trends, barriers, and translate into actionable steps
• Excellent organizational and time management skills.
• Possesses integrity, work with honesty, accuracy, and attention to detail.
• Exemplary collaboration, interpersonal and listening skills.
• Patient-centric and service-oriented mindset, with a high degree of emotional intelligence and empathy
• Knowledge of Microsoft product suite & CRM systems preferred.
• An understanding of the laws and regulations applicable to sales and marketing of pharmaceutical products to physicians and healthcare organizations not required, but preferred.
• Demonstrate strong drive, initiative, and willingness to work with a sense of urgency.
• Excellent written and verbal communication skills with the ability to translate and communicate technical/scientific concepts.
• High enthusiasm with a drive to success within a team – demonstrated ability to reach common goals in collaboration with multiple therapeutic specialists, sales leadership, market access, and patient support services colleagues
• Highly organized with a strong attention to detail
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

• This position reports to an Associate Director, Field Access Management
• This position is field based with partial remote home office responsibilities.
• This position may require up to 40-50% travel for customer visits, company meetings, conferences (dependent on area geography/size).

The anticipated annualized base pay range for this full-time position is $115,000-$155,000.  Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.  Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity.  The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.

Description

• A key component of this role is to establish collaborative relationships with Patient Services Program Partners, Field Sales, and Healthcare Providers to support patient access. Additional responsibilities will include, but not necessarily limited to, the following:
• Partner with internal and external stakeholders to identify, anticipate and address patient and HCP access barriers; Implement updates/changes based on solutions generated to address barriers
• Educate HCPs on access solutions for core and launch products
• Collaborate with key team members such as Patient Services partners, Field Sales, and other internal stakeholders to serve as access and reimbursement expert for assigned geographies
• Build strong, trust-based relationships with HCPs, Field Sales, and Patient Services partners
• Create and maintain business plans to deliver effective geography-based updates to Field Sales 
• Monitor patient start trends in assigned geographies/plans, and collaborate with Field Sales and Patient Services partners to proactively address and mitigate challenges
• Maintain and grow knowledge of national, regional, local, and account market dynamics for payors and prescribers
• Grow the knowledge of hub and specialty distribution channels to understand current policies, potential future changes, and improve patient support needs
• Collaborate with internal departments such as marketing, market access, field sales, patient services, to support patient drug accessibility
• Serve as subject matter expert regarding education and insights on access and affordability solutions across multiple payer types and plans (i.e., Medicare, Medicaid Managed Care, Commercial)
• Execute business in accordance with the highest ethical, legal, and compliance standards, including timely and successful completion of all required training 
• Remains current on and anticipates changes in product coverage and access knowledge, marketplace conditions, and stakeholder practices to deliver the most effective delivery of approved materials 
• Understands and adapts to the changing healthcare ecosystem to customize resourcing and messaging to HCPs and HCP staff

• A minimum of a B.A/B.S. required; Advanced degree within business or healthcare preferred.
• 5-8 years of experience within public or private reimbursement services, healthcare operations, and/or sales. Other backgrounds with related experience in market access, or healthcare will be considered. Pharmaceutical industry experience strongly preferred.
• Extensive knowledge of medication access channels.
• Strong functional knowledge of specialty pharmacy and health insurance and benefits (i.e. Medicare Part D, commercial and Medicaid) with a demonstrated expert understanding of insurance eligibility, benefit verification, prior authorization processes, reimbursement coverage, appealing insurance denials, application of financial assistance, co-pay support and free product programs
• Knowledge of HCP office processes regarding patient flow, prescription flow and clinic office operations. Direct experience with GI or Nephrology products or providers preferred.
• Outstanding customer relationship, interpersonal, and communication skills with the established ability to effectively work with diverse audiences and influence cross-functionally.
• Ability to master product information to effectively represent product access and information to customers.
• Ability to evaluate data and identify trends, barriers, and translate into actionable steps
• Excellent organizational and time management skills.
• Possesses integrity, work with honesty, accuracy, and attention to detail.
• Exemplary collaboration, interpersonal and listening skills.
• Patient-centric and service-oriented mindset, with a high degree of emotional intelligence and empathy
• Knowledge of Microsoft product suite & CRM systems preferred.
• An understanding of the laws and regulations applicable to sales and marketing of pharmaceutical products to physicians and healthcare organizations not required, but preferred.
• Demonstrate strong drive, initiative, and willingness to work with a sense of urgency.
• Excellent written and verbal communication skills with the ability to translate and communicate technical/scientific concepts.
• High enthusiasm with a drive to success within a team – demonstrated ability to reach common goals in collaboration with multiple therapeutic specialists, sales leadership, market access, and patient support services colleagues
• Highly organized with a strong attention to detail
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

• This position reports to an Associate Director, Field Access Management
• This position is field based with partial remote home office responsibilities.
• This position may require up to 40-50% travel for customer visits, company meetings, conferences (dependent on area geography/size).

The anticipated annualized base pay range for this full-time position is $115,000-$155,000.  Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.  Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity.  The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.

Description

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. 

• Support the reporting of Quality metrics on a monthly, and quarterly basis in support of Management reviews and KPI 
• Support various quality risk management frameworks 
• Perform batch record review and product dispositions in support of clinical trials, registration, validation, and commercial product distribution  
• Evaluate compliance of completed manufacturing records (batch records, COC/ COA, and any related data as applicable) from CMO as necessary to ensure that they are accurate and complete
• Maintain Continued Process Verification data collection in real-time at batch release 
• Review all the supporting documents regarding Quality System documentation including deviations, OOS, product complaints, CAPAs, and document /change controls-related processes
• Evaluate document changes for compliance requirements (SOPs, Master Batch records, etc.) 
• Support the analysis and reporting of product and process quality trends, and quality system performance against internal and external guidelines, standards, and regulations
• Support QA CMO oversight activities to ensure required quality standards are maintained
• Liaise with Regulatory Affairs on any manufacturing process changes that may impact regulatory filings
• Collaborate with CMC to continually improve compliance with quality systems, internal SOPs, and regulatory requirements and to resolve minor and major deviations
• Support Product complaint-handling activities. 
• Support the Annual Product Quality Report preparation
• Support cGMP compliance audits of GMP suppliers’ quality systems
• Support and conduct training for employees, as necessary
• Perform other related duties as assigned from time to time-based on company needs 

• Bachelor’s degree in science or equivalent relevant experience
• 7+ years of combined GxP experience in drug substance and drug product manufacturing process development, commercial manufacturing, analytical development, and/or quality control experience in biotechnology or pharmaceutical industries
• Experience in a manufacturing setting as a Quality person in the plant (QA PIP)
• Working knowledge and/or understanding of quality risk assessment management principles 
• Extensive knowledge of GMP regulations and guidance (such as US, EU, and ICH)
• Extensive experience with Quality Assurance systems and processes
• Effective organization and planning skills
• Demonstrated ability to deal with frequent changes, delays, or unexpected events
• Strong technical writing skills
• Advanced software skills (including SharePoint, Visio, Project, Acrobat Pro, and Veeva (a plus)) and demonstrated troubleshooting and problem-solving techniques
• Strategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groups
• Proven ability to work independently and under tight deadlines and pressure in a composed manner
• Effective interpersonal and communication skills
• Comfortable communicating with all levels of staff, including executives
• Strong team player

Location

•  Remote

Description