Overview
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.
Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are enthusiastic about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to support your personal development on our journey towards becoming a leading company in rare diseases.
Ascendis Pharma is looking to hire an experienced pharmaceutical clinician to join our Endocrine Medical Sciences team. This is an exciting opportunity to join a rapidly growing, innovative company!
Position Summary
As a member of the Endocrine Medical Sciences team for the US business, the Associate Medical Director supports the US Medical Director for deliverables and activities associated with management and implementation of phase 4 studies and registries; pre-launch-, launch-, and post- launch activities; as well as medical review of promotional materials for marketed product(s). You are a scientific contributor with expertise in endocrine and rare disorders. Responsible for either the growth-related disorders and/or hypoparathyroidism for highly visibility Ascendis TransCon Program(s), a specific focus/expertise in these areas is a major advantage. The candidate is expected to support the US Medical Director in key strategic, cross-as well functional projects as part of the US Medical Affairs Team. They will be accountable and help the US Medical Director in the development and implementation of the product medical and medical launch strategy as well as working intricately within the other medical affairs and cross -functional teams.
The candidate is expected to provide medical expertise and collaborate with a cross-functional team in the development and review of Labeling, advertising, and promotional materials. You are responsible for ensuring all promotional material for our products are medically and scientifically accurate, balanced, and aligned with brand strategy and approved indications. The ideal candidate will have significant experience in promotional reviews of materials.
The candidate may function as mentor to colleagues, support education and training of the MSL team and therapeutically focused commercial personnel (within the boundaries of company compliance SOP’s and US regulations). The Associate Medical Director is expected to develop and deliver impactful presentations and support the US Medical Director in the review and authoring of publications and collaborating/influencing publication strategy, medical information, and medical communications. Effectively conveying and communicating sound and fair balanced medical information. Represents Ascendis Medical Affairs at internal and external meetings of all levels, scientific conventions, and corporate liaison boards.
The position reports to the US Medical Director. The candidate must have availability to work in the Princeton, NJ on a weekly basis.
Key Responsibilities
- Serve as the medical/scientific reviewer of promotional assets for assigned product(s), and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling, advertising, and promotional materials.
- Ensure the materials are medically accurate, including that claims are appropriately supported by evidence, references are correctly cited, and the overall impression is fair and not misleading.
- Verify that statements in the promotional materials are consistent with the approved indication/label.
- Cross-check everything against the underlying clinical data, literature, abstracts/manuscripts and ensure that summary data are accurate and in context.
- Provide ongoing therapeutic area, product and competitive intelligence knowledge to the team to maintain up-to-date scientific accuracy.
- Build and manage relationships and strategic partnerships, and interact regularly with Key Opinion Leaders/Influencers, clinical investigators, healthcare customers, strategic alliance partners, vendors, professional societies and organizations, and patient advocacy groups.
- Work with internal stakeholders including Commercial, Legal, Regulatory, Clinical Development, Clinical Operations, Compliance, Pharmacovigilance, Biometrics, Global Communications, and other functional group contributors to support the US Medical Director in successful management of Medical Affairs projects.
- Support the US Medical Director in the design and implement medical strategies and tactical plans while providing thought leadership for medical publication planning, medical education, and medical information system development.
- Serve as a scientific expert for Medical Affairs projects within the designated TransCon Program(s).
- Support the US Medical Director in the development of strategic imperatives and tactical medical plans to enhance healthcare practitioner education to improve patient outcome.
- Support the Medical Affairs team and the US Medical Director in design and conducting post-marketing studies and medical materials review.
- Support the development, management, and execution of US Medical Advisory Boards.
- Develop and deliver presentations on MA projects to both internal and external audiences within legal, compliance and regulatory guidelines.
- Represent Ascendis Medical Affairs internally and externally.
- Stay abreast of up-to-date knowledge on all clinical data relevant to TransCon programs, competitive landscape, new therapies, clinical trends, and newly issued regulatory rules and FDA guidance to promptly identify any potential impact on existing medical programs or strategies, competitive environment, or changes to product programs.
