Medical Director, Medical Affairs

REMOTE
Princeton, New Jersey, United StatesClinical Development & Medical Affairs Endocrinology, Medical Affairs1178
Description
Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate 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 (Director) to join our Endocrine Medical Affairs team.
This is an exciting opportunity to join a rapidly growing, innovative company!
Position Summary
With the Head of Medical Affairs office, the Medical Director, is responsible for deliverables and activities associated with management and implementation of late-stage studies; pre-launch-, launch-, and post- launch activities; as well as life-cycle management activities for marketed product(s). The candidate is a scientific and clinical leader in the endocrine space with a specific focus on PTH and growth hormone. Responsible for either the growth or PTH therapeutic area for high a visibility Ascendis TransCon Program.The candidate is expected to lead key strategic, cross-as well functional projects as part of the US and Global Medical Office.They will be accountable and assist the Head of the US medical office (Strategy and Engagement) in the development and implementation of the product medical and medical launch strategy as well as work intricately within the medical affairs and cross -functional teams.
The candidate is expected to build and manage long-term relationships and strategic partnership with Key Opinion Leaders, Influencers, research center, clinical investigators, strategic alliance partners, vendors, professional societies and organizations, and patient advocacy groups. She/He oversees the execution and develops post marketing and phase IV clinical programs including, patient registries and provides oversight of investigator-initiated research (IIRs) as well as Special access programs. Coordinates clinical monitoring process in the Ascendis Medical Affairs Department in accordance with GCP’s and global SOPs. The candidate may be a mentor to colleagues, support education and training the RMS team and related sales force personnel (within the boundaries of company compliance SOP’s and US regulations) and leads the development and execution of US Advisory Boards. The Medical Director is expected to impact presentations, participate in the authoring of publications and collaborating/influencing publication strategy, medical information, and medical communications. Towards effectively 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 Head of the Medical Affairs Office (Strategy and Engagement) based in Princeton, New Jersey.
Key Responsibilities
With the Chief Medical Officer and Vice President, Medical Affairs, With the HMAO the candidate is engagement and co-accountable to define strategy, develop and refine Medical Affairs policies and procedures and SOPs, to ensure and maintain excellence in standards and practices.
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, Pharmacovigilance, Biometrics, Global Communications, and other functional group contributors to ensure successful management of Medical Affairs projects.
Work closely with Commercial and other key parts of the organization in the design and implementing of launch strategies and tactics, as well as life cycle planning.
Provide assessments of product opportunities and threats.
Designing and implementing medical strategies and tactical plans while providing thought leadership and tactical execution for medical publication planning, medical education, medical information system development.
Serve as a clinical and scientific expert for Medical Affairs projects within the designated TransCon Program.
Develop strategic imperatives and tactical plans to enhance healthcare practitioner education to improve patient outcome.
Provide leadership to the Medical Affairs team and actively participate in design and conducting Phase IIIB/IV studies and medical materials review; serve as a Medical Monitors for these studies.
Oversee investigator-initiated Research (IIRs) and compassionate use programs.
Lead the development, management, and execution of US Advisory Boards.
Foster research relationships with key research centers in the US.
Provide medical expertise, and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling, advertising, and promotional materials.
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 possible impact, competition, or improvements to product programs.
Requirements
M.D. degree highly preferred (PharmD, Doctorate level Nurse, or PA may also be considered assuming at least 5 years of direct clinical practice in a relevant therapeutic area)
At least 7+ years of industry with at least 3 years of clinical practice in NA or EU or similar (academic experience is a plus and not mandatory)
Substantial knowledge/experience in endocrinology especially rare and Orphan diseases (preferred)
Strong track record of scientific and clinical inquiry
Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.
Demonstrated strategic and critical thinking.
Excellent communication skills (oral and written) and demonstrated organizational skills.
The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analysis.
Estimated salary: $275-$320,000/year DOE, salary and title commiserate with experience.
Benefits
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid maternity leave
Paid paternity leave
Commuter benefits
Disability insurance