Senior Director, US Medical Affairs | BioNJ Talent Services

Senior Director, US 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 (CHART™) 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:

The Senior Director, U.S. Medical Affairs will build and manage the U.S. Medical Affairs team, closely leading and overseeing medical strategy, project execution, Investigator Initial Trials, MSLs and medical communications for all Amicus medicines. The Senior Director, U.S. Medical Affairs will be responsible for providing medical insight, guidance, strategy, medical review, and training as needed to Medical Affairs and to senior management and will work with Market Access teams to develop compelling medical evidence to support optimal patient access to medicines. He/she will develop the regional Medical Affairs strategies as well as provide operational guidance and oversight of US activities related to Medical Communication, Medical Education, Investigator Initiated Research (IIT) and Key Opinion Leader (KOL) outreach.

The Senior Director, U.S. Medical Affairs will represent Amicus in scientific presentations, conferences and industry groups; serve as lead spokesperson with KOLs and interact with various Government agencies, and support optimal life- cycle management. He/she will partner with the Compliance and Legal Departments to ensure that Medical Affairs activities are conducted in a manner that is compliant with Amicus policies, procedures, and local regulatory/legal requirements.

Roles and Responsibilities
Build and lead the US Medical Affairs organization, setting the strategic direction of US Medical Affairs in alignment with the Global Medical Affairs objectives.
Build partnerships and relationships with the scientific and medical community. Represent Amicus externally in scientific presentations, conferences and industry groups.
Oversee the interpretation, publication/public disclosure, and accurate use of scientific data concerning migalastat in Fabry disease and ATB200 in Pompe disease (as well as future products), and oversee the development of scientific content for medical communication and scientific education initiatives.
Provide strategic input into the development of Phase III b/IV trials in collaboration with other stakeholders.
Interact with key members of the medical community to assist in understanding current practice issues for Fabry disease, including developing and maintaining
Form and enhance working relationships with key external research collaborative groups.
Actively participate and ensure US Medical Affairs contributions to various teams and taskforces to build and support the Amicus portfolio in all facets of the business, with an emphasis on:
Pricing and reimbursement
Lifecycle management
Serve as an ethics and compliance role model for the US Medical Affairs function and broader Amicus community.
Drive a high performance culture by fostering innovation, customer focus, personal accountability and commitment for results.
Lead regional medical strategies and project executions that support clinical development, including trial design and recruitment, early access initiatives, investigator initiated research/studies (IIRs/IISes), publications and other medical communications.
Provides medical insights and guidance including strategy, medical review, competitive intelligence and training for key commercial projects and business development opportunities.
Works closely with commercial team to develop compelling medical evidence to support optimal patient access to our medicines.
Works closely with Patient & Professional Advocacy
Works with headquartered and field-based medical teams (MSLs) to grow and manage a thought leader network to support successful implementation of plans.
Ensures safe and appropriate use of medicines.

Qualifications: 

MD preferred, board certified in internal medicine or pediatrics preferred. Will consider PharmD, PhD with significant experience and a proven record of accomplishment
10+ years of relevant academic, clinical and industry experience.
Rare Disease experience highly desirable.
Demonstrable executive leadership experience in Medical Affairs in a pharmaceutical/biotech organization, having led a regional/global medical affairs team.
Track record of having played a central role (from a medical perspective) in product launches.
Specific knowledge of the metabolic diseases field advantageous.
Solid understanding of the global regulations that govern Medical Affairs activities as well as detailed knowledge of common local, medical practices and treatment habits.

Experience and Skills
Experience in negotiations with payers in the US, with the ability to shape and articulate the value story of specialty therapeutics along with proven lobbying and relationship building skills.
Experience with products in the orphan drug arena would be advantageous, however more important is the understanding of specialty therapeutics addressing unmet medical needs.
Demonstrated ability to maintain scientific credibility while being commercially supportive, and to communicate scientific results and effectively respond to data queries from customers and/or consultants.
High proficiency in problem solving ability and strong scientific analytical skills.
Experience with and understanding of the drug development process, including scientific understanding of basic physiology, pharmacology/biology, pharmacokinetics, and the role of preclinical studies in drug development.
Proven leadership skills and building effective teams.
Confidence and credibility to partner as peers with commercial counterparts.
Demonstrated ability to work effectively in a matrix environment, and hold position without extensive medical infrastructure support.
Will have clear alignment with Amicus values and culture including the ability and desire to interact with multidisciplinary teams, setting up a collaborative environment.
Learning agile and ‘scalable’ to take on increasing responsibility and management as Amicus grows.
Passion and fortitude to lead initiatives and willing to take stand to advocate for programs.
Passion for science and strong professional customer and patient orientation.
Excellent written and oral communication skills (in English), including strong formal presentation skills in front of internal and external audiences with the ability to “speak up” in meetings with scientific leaders and experts and to communicate in lay language in meetings with patients and caregivers.
Ability to hire, manage and develop home-office based and field-based medical teams.
Ability to define strategy and execute short- and long-term medical plans.
Strong organizational and communication skills.
Experience reviewing, approving and overseeing post marketing clinical studies.

Travel
30%-40 - Domestic/International

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