Associate Director, Medical Affairs Reparixin Clinical Programs

Employer
Dompe U.S.
Location
Field Based
Posted
Mar 23, 2021
Ref
Field Based
Required Education
Masters Degree/MBA
Position Type
Full time

Ciao! At Dompé, our success is rooted in our team and our history. We are a private, rapidly growing global biopharmaceutical company.  Founded in Milan, Italy, we have a 165-year legacy of medical innovation. Dompé’s rich history has greatly influenced its priorities today: to innovate for the benefit of patients facing both everyday wellness needs and rare conditions. Dompé operates in two strategic areas in select markets around the world: Primary Care, which includes prescription and over-the-counter products; and Biotechnology and Rare Disease, which recently expanded into the United States.

Today Dompé has 700 employees worldwide and we are excited to be rapidly scaling in the United States. Our R&D hub is currently based in Boston, and the commercial organization is housed in the San Francisco Bay Area. 

YOUR ROLE AT DOMPÉ

Associate Director, Medical Affairs

Under the direction of the Global Head of Medical Affairs, the Associate Director of Medical Affairs is responsible for working with key stakeholders to develop and execute the medical affairs plan, including medical education, research, grants, medical advisory boards, and scientific communications, educational materials prelaunch-launch. As well as support and drive enrollment for clinical trials and maintain primary investigators relationships and support. Primary areas of focus will include Reparixin Clinical Programs, specifically the area of cancer related fatigue (CRF), inflammatory diseases and COVID, with the educational need focusing on high-unmet medical needs. Utilize expert medical/scientific knowledge in assigned therapeutic areas to provide medical insights to further expand medical education and medical affairs plan and contribute to growth of clinical trial programs through commercialization. Liaise with external stakeholders and key opinion leaders to solicit feedback and strengthen medical reputation in the disease state community and to increase disease awareness. Maintains personal expertise in relevant disease areas and medical affairs compliant practices and drives growth and support externally and internally. Support pivotal trial activities to liaise PI activities and drive study enrollment. 

 

MAIN AREAS OF RESPONSIBILITIES OF THE ROLE:

• KOL/PI Engagement: Lead for identification of KOL/PI list and KOL engagement plan. Manage all 1:1 US meetings, executive encounters, investigator meetings with CRO, KOLs and researchers. Coordination of advisory boards including KOL identification, content development and internal review and approval. Develop and maintain list of investigators that can contribute to pre and post marketing study activities by advanced site selection process. 

• Clinical Development/Clinical Trial Activities: Responsible for working cross functionally with clinical development and CRO to ensure US site selection is validated and appropriate for therapeutic target.  Works with multifunctional consortia teams to design study protocol and selection/support of CRO. Lead and support steering committee meetings for study and review of sites and clinical content. Support all PI activities and develop yearly clinical trial plan for medical affairs to help drive enrollment through PI/KOL support and other digital and external strategies.

• Internal Leadership:  Manage budget and resources relevant to medical affairs function and manage metrics to track success. Ensure development and execution of clinical development plan, in partnership with the Global Head of Medical Affairs and Head of Clinical Development. Ensure SOPs are implemented and updated as needed as therapeutic area responsibilities advance. Lead all approval activities for Reparixin in both PRC and MLR.

• External Leadership: Establish and maintain scientific and clinical relationships with medical professionals, researchers, PIs, payor groups and other members of the scientific community in alignment with a therapeutic area of focus.  Manage external vendors supporting medical activities, providing clear direction and ensuring timely completion of key deliverables. 

• Clinical Expertise: Serve as the clinical expert in Reparixin and the role of IL-8 in disease and be the voice for medical affairs to internal and external stakeholders. Attend and provide scientific support and intel reports for all medical and scientific sessions at regional and national congress meetings. Serve as the lead for the Global Product Teams.

• Medical Leadership: Development and refinement of medical strategies and tactics in coordination with Global Head of Medical Affairs and the CMO. Provide scientific input and participate in local medical and cross-functional initiatives. Provide field-based medical support to clinical research programs, registries, and facilitation of clinical trial recruitment process. Ensure recruitment is managed for the trial and implement strategies to have continuous recruitment. Support all regulatory and clinical development programs in pre-IND phases. 

• Publication and Communications Management: Maintain awareness of and access to internal and external information sources available to support high-quality scientific exchange with HCP through collection portal. Development and execution of publication strategy and tactics to increase knowledge in CRF to include but not limited to manuscripts, abstracts, posters, presentations, medical education, guidelines/consensus. Continuous medical literature and critical appraisal of scientific publications to ensure business is aligned to direction of therapeutic area. Development of publications and abstracts for clinical programs internally.

• Medical Affairs Strategy Development and Execution Prelaunch-Launch: Under the direction of the Global Head of Medical Affairs, work with key stakeholders and functional area leads in the development and execution of key elements of the medical plan for Reparixin.  Ensure all activities are conducted with the highest levels of scientific rigor and in full compliance with applicable rules and regulations. Responsible for the development and review of all medical content as related to therapeutic area. Ensure close collaboration with all internal cross functional partners to ensure medical prelaunch and launch plans are aligned to business goals.

We are seeking team members who will live by and promote the core values of our Dompé culture: Integrity, Speed, Knowledge, Passion, Attention to Detail, Reliability, Flexibility and Teamwork. We are looking for individuals who possess an entrepreneurial spirit, flexible attitude, and adaptable nature to join our team.

BUILDING INTERNAL RELATIONSHIPS: WHO THE AD, MEDICAL AFFAIRS WORKS WITH WITHIN DOMPÉ

  • Global Medical Affairs 
  • Regulatory Affairs
  • Global Clinical Development
  • Drug Safety
  • Commercial and Sales 
  • Legal, Ethics and Compliance
  • HR

BUILDING EXTERNAL RELATIONSHIPS: WHO THE AD, MEDICAL AFFAIRS WORKS WITH OUTSIDE OF DOMPÉ

  • Key opinion leaders (KOLs)
  • Principal Investigators (PIs)
  • HCPs and Allied Health Professionals 
  • Patient advocacy groups
  • Regional policy makers
  • National & Regional Societies

YOU COULD BE THE PERFECT FIT IF YOU HAVE:

  • An advanced degree in life sciences (MD, DO, DNP, PharmD or PhD) required

  • Clinical expertise in CXC chemokine receptor (CXCR) 1 and CXCR2. Specific expertise in inflammatory disorders required

  • Clinical or Medical affairs experience in inflammatory and autoimmune diseases, specifically ones with manifestations related to IL-8. Oncology (cancer related fatigue) or COVID as an area of interest in research or KOL relationships.

SKILLS YOU’LL NEED FOR SUCCESS: TECHNICAL

  • Minimum of 4 years of industry experience in a diagnostics or pharmaceutical Medical Affairs setting
  • Experience with new product launches preferred
  • Clinical research experience, including conducting clinical trials required 
  • Experience working with cross-functional medical, clinical development and commercial teams
  • Exceptional verbal and written communication skills
  • Strong problem-solving skills, good attention to detail, time management skills and personal initiative
  • Experience working with experts at academic medical centers to build consensus around new products and/or services

SKILLS YOU’LL NEED FOR SUCCESS: PERSONAL

  • Communication

  • Self-Motivation

  • Leadership, Inspiring & Influencing

  • Teamwork & Collaboration

  • Problem Solving

  • Decisiveness

  • Time-Management

LOCATION AND TRAVEL:

  • This position is field based 
  • Ability to travel 60-70%, including weekend conferences

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.