Ascendis Pharma is applying its innovative TransCon technologies to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies.

Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development. The company continues to expand into additional therapeutic areas to address unmet patient needs.

Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, Palo Alto and Redwood City, California, and Princeton, New Jersey.

Ascendis Pharma

Operations

Lead global pharmacovigilance operations for Ascendis pharmaceutical products.

• Support Study Management Teams (SMTs) as an active member representing PV Operations team.
• Participate in the conduct of Sponsored and Investigator Initiated Trials for Ascendis products
• Responsible for the review of study documents including but not limited to Study Protocol, Safety Management Plan (SMPs), Data Management Plan etc.
• Support SAE Reconciliation activities for assigned studies as applicable
• Responsible for study classification (i.e. interventional studies, noninterventional studies, Post Approval Safety Studies (PASS) etc.)
• Oversees the PV vendors/service providers to ensure that they fulfill their accountabilities and responsibilities, which includes, but is not limited to:
• Responsible for assigned PV activities/projects and working collaboratively with other teams within Ascendis.
• Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products.
• Ensures that adverse events from spontaneous cases, solicited cases and from studies and programs involving Ascendis products be collected, reported, and handled in accordance with global/local regulatory requirements and company policies
• Responsible for operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable
• Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
• Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff
• Ensures processes are adhered to that support on-time and appropriate ICSR submissions
• Supports the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc.)
• Provides pharmacovigilance expertise to Ascendis or CRO/Vendor staff when needed
• Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and other Service Providers (SPs) vendors. These activities include, but is not limited to:
• Ensuring SP/vendor oversight under the guidance of Head of Global PV Operations by contributing to the Vendor Quality Agreements
• Liaise with functional units to identify Market Research and Patient Support programs (MAPs)
• Provide strategic input on the conduct of MAPs to ensure compliance with PV requirements
• Accountable for maintaining oversight over Source data quality check [SDQC] activities and/ or Case Transmission Verification (CTV) activities and ensure tracking and timely completion
• Raises or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required.
• Monitoring GVP and PSP SPs to identify areas of risk and develop strategy and action plans to ensure compliance
• Overseeing and supporting implementation of CAPAs as necessary
• Work Closely with Ascendis GCP/PV Compliance team and Commercial organization as required to ensure oversight of GVP and PSP SPs
• Additional activities may include but is not limited to:
• Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
• Work collaboratively with Medical Safety Science team for assigned activities
• Is responsible for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as necessary
• Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head of Global PV Operations (example: Local PV agreements, CRMs, Digital Media etc.)
• Participate in relevant crisis management activities within the scope of Ascendis PV group

Associate Director - Global PV Operations

Sales

• The Regional Sales Director (RSD) will serve as a critical member of the Sales Leadership Team and will have an exciting opportunity to lead the development and expansion of Ascendis Pharma’s sales organization in preparation for the successful launch of the Company’s second biologic product in the rare endocrine disease area. The RSD will initially be responsible for the identification, interviewing & hiring of our expanded Field Sales Team and transition into leading his/her geographical area to meet or exceed all assigned goals by maximizing the effectiveness and productivity of the Endocrine Clinical Specialists (ECS), while maintaining compliance with Ascendis Pharma’s policies that govern field sales activity. This role will have a a primary focus on supporting the anticipated launch of an investigational treatment for hypoparathyroidism currently under review by the FDA
• The role also requires the ability to create a culture of winning through effective recruitment & hiring, coaching & development, collaboration across the organization, strategic decision making and timely performance management. Developing strong, business focused partnerships with internal Ascendis colleagues in Marketing, Market Access, Medical Affairs, Commercial Operations, Human Resources & Training will be essential for success.
• Location is flexible; access to a major airport is needed
• As the first line management job within Sales at Ascendis Pharma, RSDs act as liaisons between field sales and the various internal departments whose work impacts or is impacted by field activity. As a conduit of information to and from the field, RSDs must facilitate ECS recognition and understanding of how changes in the industry, or within Ascendis Pharma, affect their approach to selling. As a way of maintaining high motivation and commitment from the sales team, the RSD must transfer information from corporate, translating it into terms that can be easily understood and accepted.
• The RSD will establish and inspect clear and rigorous business fundamentals, behaviors and metrics, set high performance standards and meet or exceed sales goals across the business
• The RSD will create immediate impact by successfully hiring, leading, coaching and motivating the high-performance sales team
• RSDs are expected to adapt quickly to needs/adjustments necessitated by launch preparations and contribute to supporting both corporate and field- based colleagues in navigating a dynamic and evolving market to achieve and exceed expected results in a complex specialty environment
• Coaching ECSs in line with Ascendis Pharma’s sales model to drive sustained improvement in core sales competencies; this includes clinical, product, business acumen as well as reimbursement skillsets. Routinely participate in Sales field rides, face to face customer meetings, target planning, territory alignment and develop employees based on observed knowledge, skill & behavior opportunities
• Contribute to the development of the National Sales plan that aligns to organizational goals, leveraging analysis and interpretation of general economic, industry, marketing and sales data
• Ensures the timely and accurate completion of all territory and regional level administrative tasks, including; expense reporting, program funding requests and management communications

Regional Sales Director

• Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
• Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
• Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
• We are currently conducting a national expansion and seeking Endocrine Clinical Sales Specialists who will be responsible for understanding and identifying a customer’s needs, support pull-through activities relative to the customer strategy, and to ensure that Ascendis Pharma is viewed as a valued partner to healthcare professionals and their patients. This person will have a primary focus on supporting the anticipated launch of an investigational treatment for hypoparathyroidism currently under review by the FDA. The Endocrine Clinical Sales Specialist is accountable to develop superior product and disease state knowledge that allows them to engage in appropriate clinical dialogue with healthcare professionals. They must effectively educate on approved indications and product efficacy/safety profiles to support on-label prescribing for appropriate patients. Using your product knowledge to engage in customized discussions and in person interactions based on customer’s needs in a compliant and ethical manner. Drive outstanding sales performance that ensures sales forecasts are met or exceeded. Effectively uses assigned budgets to drive therapeutic and territory expectations. Maintains current understanding of local market, practice structures, business models, and key influencers. Routinely shares such information with relevant Ascendis stakeholders (e.g., Sales and Commercial Leaders). Works with appropriate customers and accounts to understand practice structure, business model, key influencers, network structure, customer needs and to identify business opportunities. Can effectively and routinely use a variety of analytical tools to understand and evaluate the business to best determine how to accomplish sales objectives and apply appropriate resources in an effective and ethical manner. Work with leaders to develop a business plan that ensures achievement of all goals and delivery on all sales objectives. Also work to understand formulary approvals and other opportunities and how they fit into the effective implementation of the business plan. Collaborate with internal stakeholders to deliver appropriate resources and pull-through within the territory. Demonstrate administrative excellence to ensure competent management of work hours, sales call data, customer objectives responses, sample and expense reporting and other administrative items.

Endocrine Clinical Sales Specialist

• The Endocrine Clinical Specialist will promote Skytrofa and be accountable to develop superior product and disease state knowledge that allows them to engage in appropriate face to face clinical dialogue with healthcare professionals.
• Use product knowledge and selling skills to engage in customized client discussions and interactions based on specific customer needs in a compliant and ethical manner.
• Drive outstanding performance that ensures sales forecasts are met or exceeded.
• Executes strategies and tactics and invest assigned budget and resources to drive territory expectations while focusing on the needs of customers and patients.
• Maintains current understanding of local market, practice structures, business models, and key influencers and conduct in person meetings with health care professionals.
• Calling on Pediatric Endocrinologists as the primary customer and have demonstrated experience with gaining access into institutions and the ability to navigate children’s hospitals and delivery networks.
• Proactively shares such information with relevant Ascendis stakeholders (e.g., Sales and Commercial Leaders)
• Demonstrates tenacity in challenging market access scenarios
• Utilizes technology platforms to engage and educate HCPs
• Effectively and routinely uses a variety of analytical tools to understand and evaluate the business to best determine how to accomplish sales objectives and apply appropriate resources in an effective and ethical manner
• Develops, communicates & executes a business plan to achieve and surpass all goals and delivers on all sales objectives and behaviors
• Proactively collaborate with peers and internal stakeholders to maximize impact of appropriate resources to pull-through value within the territory and across Ascendis
• Effectively sell on approved indications and product efficacy/safety profiles to support on-label prescribing for appropriate patients
• Demonstrate administrative excellence to ensure competent management of work hours, timely and accurate sales call data, customer objectives responses, sample and expense reporting and other administrative items
• Partner with the access team to develop appropriate strategies that drive access to the brand
• Supporting the Mission and Values of Ascendis; Patients, Science & Passion

• The Regional Sales Director (RSD) will serve as a critical member of the Sales Leadership Team
• Lead the development and expansion of Ascendis Pharma’s sales organization
• Identify, interview & hire the expanded Field Sales Team
• Develop and lead geographical area to meet or exceed all assigned goals
• Maximize the effectiveness and productivity of the Endocrine Clinical Specialists (ECS)
• Create a culture of winning through effective recruitment, hiring, coaching, development, collaboration, strategic decision making, and timely performance management
• Develop strong, business-focused partnerships with internal Ascendis colleagues
• Establish and inspect clear and rigorous business fundamentals, behaviors, and metrics
• Create immediate impact by successfully hiring, leading, coaching and motivating the high-performance sales team
• Adapt quickly to needs/adjustments necessitated by launch preparations
• Contribute to the development of the National Sales plan
• Ensure timely and accurate completion of all territory and regional level administrative tasks

Ascendis Pharma Jobs in New York City