Senior Manager, Scientific Alignment - job ID: 1463

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.

Scientific Affairs is a key division within Global Medical Affairs responsible for Medical Communications, Scientific Training and Development, Medical Information, and Scientific Alignment. As a member of the Global Medical Affairs team, the Senior Manager, Scientific Alignment will serve as a member of the US Legal, Medical, and Regulatory (LMR) review committee, reviewing US Commercial and Medical materials. The Senior Manager ensures materials are medically accurate, fair-balanced and aligned to core scientific global messaging. Further, this individual will work collaboratively with Regulatory, Legal, and US Commercial to facilitate delivery of promotional materials with excellent clarity, consistency, precision, and accessibility.

To foster high scientific standards, the Senior Manager will be a subject matter expert and will engage in early concept reviews, constructive discussions, and provide actionable and clear guidance for Medical and Commercial colleagues on various externally facing and internal training materials. The individual will work closely with the entire Global Medical Affairs organization, particularly within Global Medical Strategy, Medical Information, Medical Communications, and Scientific Training and Development. The Senior Manager will be a key contributor to the development and review of aligned global scientific messaging in Ascendis Pharma’s Scientific Communication Platforms across current and future therapeutic areas.

The position reports to the Director, Global Head of Scientific Alignment.

Key Responsibilities

• Represents Global Medical Affairs as the Medical Reviewer in US LMR, responsible for review of US Commercial and Medical materials
• Demonstrates a command of therapeutic areas and expertise with products in growth hormone deficiency, hypoparathyroidism, achondroplasia, and other therapeutic areas in development
• Analyzes and critically evaluates scientific data in medical, non-promotional, and promotional materials
• A key contributor and project lead for Scientific Communication Platforms for aligned and strategic global scientific messaging
• Supports content development for Medical Information across products (Medical Content Letters, Custom Response Letters, FAQs., etc.)
• Provides perspective on the development and revision of SOPs, implementation guidelines (IGs), and Work Instructions (WIs) as necessary
• Contributes to the development and execution of Global Medical Affairs strategy and strategic imperatives across therapeutic areas
• Develops medical slide presentations for internal and external use
• Provides guidance for the appropriate use of scientific evidence by reviewing materials developed by external compendia (e.g., Medical Letter, MediSpan, treatment guidelines)
• Ability to research, develop, and write content that is scientifically accurate, evidence-based, grammatically accurate, referenced using appropriate sources, and consistent with quality and regulatory standards
• Supports development of internal scientific training materials for Field Teams, Medical Information Call Center, and others as appropriate
• Participate in vendor selection activities and manage various vendors and associated budgets
• Works closely and develop strong partnerships with internal stakeholders including Marketing, Market Access, Regulatory, Legal, Clinical Development, Clinical Operations, Biometrics, Corporate Communications, Program Management and other functional group contributors to ensure successful alignment of communications
• Stays abreast of up-to-date knowledge on all clinical data relevant to all Ascendis Pharma programs, the competitive landscape, new therapies, clinical trends, and newly issued regulatory laws and FDA guidance to promptly identify possible impact, competition or improvements to product programs

Requirements

• At least 6 years of industry experience in Medical Communications or Medical Affairs, or as part of a Medical Communications agency required
• Previous Medical Reviewer expe