- Leads and directs the US Medical Directors to drive the development and execution of the US Medical Affairs strategy and tactics in alignment with key stakeholders.
- Develops and executes the US Medical Affairs Plans required for successful launch and life cycle management activities.
- Responsible for the medical content of the launch and life cycle plan.
- Responsible for the strategy and execution of phase IV (post-marketing, Registry, Early Access Programs-EAP).
- Functions as the external medical expert for Ascendis Pharma products during the development and execution of advisory boards, medical education programs, and medical conferences.
- Function as the internal medical expert, supporting the development of product training materials, and developing/reviewing the medical content of medical field force and commercial communication material.
- Maintains medical expertise of the endocrine space including thorough knowledge of relevant products.
- Supports the Field based US Medical teams(MSL/HEOR Field).
- Supports the publication plan and timelines.
- Assists the Medical/Clinical/Commercial teams with support and communication with investigators.
- Pro-actively Identify unmet need and evidence gaps and identify opportunities to address them.
- Establishes and develops relationships with a wide variety of healthcare professionals to achieve scientific, advocacy, educational, and patient outcome goals on behalf of Ascendis Pharma.
- Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs activities and services are fully compliant with Ascendis SOPs and US as well as global regulatory and compliance rules/law.
- MD or MD/PhD or equivalent degree is required.
- Background in a Pharmaceutical Endocrinology leadership role is highly preferred.
- Must HAVE 15+ years of experience working in pharmaceutical or biotech Medical Affairs or Clinical Drug Development.
- Experience with Medical Affairs activities including but not limited to, KOL engagement, clinical research, drug development, commercial planning and medical strategy.
- Ability to work in a fast-paced environment with cross-functional responsibilities including, but not limited, to aid addressing complex problems, and supporting medical and clinical needs.
- Knowledge of drug launch activities, regulatory requirements governing clinical trials and experience in development strategy and the design of drug launch.
- Possess exceptional communication skills, both oral and written with the ability to influence internal and external stakeholders.
- Keen analytical skills and demonstrated ability to translate high-level business needs and objectives to actionable plans.
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Head of US Medical - Princeton, New Jersey, United States - Ascendis Pharma
Description
The Head of US Medical - Endocrine Medical Affairs will report to the US General Manager with primary responsibility to lead the US Medical Directors and ensure the compliant execution of all medical programs and functions associated with the late-stage development and medical aspects of commercialization of endocrine assets at Ascendis Pharma.
In addition to leading the strategy and execution of phase IV (post-marketing, Registry, Early Access Programs-EAP) the role includes being a thought partner with our clinical development colleagues for the purpose of driving innovative development strategies, as well as being a collaborator with commercial colleagues helping to ensure strategies benefit from the insight of an experienced pharmaceutical physician.
Key ResponsibilitiesA note to recruiters:
We do not allow external search party solicitation.
Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from:
Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Benefits
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid maternity leave
Paid paternity leave
Commuter benefits
Disability insurance
