Director, US Field Medical Affairs | BioNJ Talent Services

Director, US Field Medical Affairs

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHARTâ„¢) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

The Director of US Field Medical Affairs provides strategic and tactical leadership to all US MSLs. This person is responsible for support across all products including those with marketing authorization and those in development in accordance with the highest standards of ethics and compliance. The Director ensures close strategic and operational alignment between Medical Affairs and the MSL team as well as between all cross-functional stakeholders and partners in the field. This position is responsible for the recruitment, development, leadership and ongoing management of the field MSL team including staffing, budgeting, tracking of spending and ensuring they meet goals and objectives that are aligned with Medical Affairs.

Roles and Responsibilities
Manage the MSL team in supporting scientific and medical communications and building strong peer-to-peer relationships with thought leaders in support of Amicus marketed products and those in development. This includes hiring, coaching/training, setting direction, motivation, territory alignment, appraisal and review of MSLs.
Responsible for approval of MSL team travel and field expenses
Manage the provision of all training and required resources for successful group utilization of education and research opportunities. Collaborate with internal and external stakeholders to provide product/therapeutic training and other skill development.
Plan and develop budget; track spend and ensures adherence to approved budget.
Conduct KOL mapping and provide periodic updates; ensure that all MSLs develop KOL engagement plans that are aligned with Medical Affairs strategic objectives.
Oversee MSL team involvement, attendance and reporting at scientific meetings/congresses and ensures that MSLs are well-prepared for clinical data presentations, conferences, and internal or external meetings.
Work with individual MSLs to identify and develop collaborative working relationships with regional and national thought leaders.
Assist in strategic management of investigator initiated studies (IIS).
Ensure that the MSLs track their individual projects according to the agreed milestones and that IIS are completed as budgeted.
Manage the MSL team to support R&D and the clinical operations team with all US clinical studies
Collaborate with Clinical Operations to identify potential research sites.
Collaborate with Patient & Professional Advocacy to provide medical support.
Communicate to investigators and KOLs regarding study progress, results, etc. and provide any additional on-site assistance to facilitate study progress.
Provide strategic input, interact, collaborate and ensure alignment with Medical Affairs objectives. Collaborate and communicate with Marketing, Clinical Research, Regulatory Affairs, and Quality Assurance as appropriate.
Interact and collaborate with Legal/Compliance, Human Resources and Finance Departments to ensure an effective, compliant and strategically focused US MSL Team.
Ensure compliance with legal and regulatory guidelines to emphasize and provide medical and scientific accuracy and fair balance in all MSL communications.
Assure cutting edge benchmarked expertise in thought leader development, investigator research, competitive intelligence, and R & D / marketing support. Also, assure that the entire MSL team maintains clinical, scientific, and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings
Foster an atmosphere conducive to teamwork and collaboration - a strong leader of highly trained clinicians and field team managers.

Qualifications: 

MD, PharmD, or PhD, (will consider candidates with a Master degree with >10yrs experience in MSL field management)
MSL experience and 5+ years management experience preferred
Experience in rare diseases is a plus
Track record of success in building, developing and managing a strong MSL team
Must know FDA regulations, PhRMA Code, OIG and AACME guidelines and regulations
Skilled in reviewing, understanding, and presenting medical and other technical material.
Since this position frequently involves consultation with key decision-makers and opinion leaders, must be able to convey ideas effectively in ways that will influence others.

Experience and Skills
Skilled in communicating with internal and external stakeholders
Strong computer skills including but not limited to MS Word, Excel, PowerPoint
Excellent organization skills, budget management
Must be able to work autonomously
Additional competencies for success: people & team management, time management, negotiating, organizing, process management, and timely decision making.
Travel approximately 60% (nationally), including travel to Company office at least once per month if position is field based
Must live within 45 minutes of a major airport in the U.S.
Must possess a valid driver’s license in the state of residence; must possess and maintain a satisfactory driving record

Travel
Up to 60%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Medical