Field Based / Remote (United States) /

Biotech – Medical Affairs /

Full-time

/ Remote

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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 750 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.

PURPOSE OF THE ROLE

Under the guidance of the Global Head of Medical Affairs, the Director/Senior Director of US Medical Affairs develops and ensures execution of the country field medical affairs strategy and tactics. Aligns strategy and tactics to overall company strategy and yearly plans to ensure medical organization is driving the highest scientific value. They will ensure strategic execution of the field medical teams to ensure strong advocacy with PIs/KOLs and other stakeholders in patient care, establishes strong professional relationships, provides credible scientific expertise. Provides effective communication and support to cross functional teams including Medical Communications, Medical Information, BD, Marketing, and Sales. Continuously maintains personal expertise in relevant disease areas, medical affairs compliance and best practices, clinical trial best practices that can be applied externally and internally.

MAIN AREAS OF RESPONSIBILITIES OF THE ROLE

• Medical Affairs (Field Medical-MSLs) Leadership:
• Lead the US field based MSL Directors and support the MSL team
• Develop and manage field strategy, budget, KPIs, individual goals and resources relevant to the MSL team and manage all metrics to track success. Ensure alignment with US medical and brand strategies to ensure field strategies are driving the greatest success.
• Create bi-annual KOL and HCP target lists. Utilizing and creating data to understand and stratify activities based on applicable targets.
• Ensure development and execution of clinical training strategy in partnership with MSL Director to ensure MSL field team are adequately trained and knowledgeable. Join all certification and applicable ride along.
• Provide appropriate mentoring and coaching to direct reports with respect to technical skills, business acumen/planning, and effective territory management.
• Enable an environment for cross functional partnerships to ensure team alignment with marketing, sales, and field marketing as appropriate per company standards. Share monthly updates on a recurring call regarding MSL activities and important medical information and field insights.
• Ensure teams are trained on current SOPs that apply to them and conduct training to ensure compliant execution of their activities. Create and update policies as needed to ensure alignment with tactics.
• Attend cross-functional field leadership meetings to identify current & future business needs and to continuously gather 360 feedbacks.
• Serve as the field representation during QBR meeting as opportunity to communicate field achievements each quarter (quantitative and qualitative reports/slides) and articulate how the MSL team is alignment and executing on the strategy.
• Lead workshops and schedule cross functional meetings to collect feedback on field strategy.


• External Medical Affairs (Field Medical-MSLs) Leadership:
• Attend meetings with Directors and MSLs to exemplify and communicate company and medical organization objective to KOLs and HCPs.
• Attend conference KOL meetings, KOL lunches/dinners, and KOL events to communicate medical affairs priorities and how KOLs can best engage with the field teams.
• Host field advisory boards and consulting sessions to seek feedback on field strategies
• Ensure high standard of professionalism to develop and maintain “peer-to-peer” scientific relationships with key thought leaders in research, healthcare, academia, payer, and government organizations, including the management of strategic scientific partnerships and scientific exchange with key research physicians contracted with Dompe.
• Seek opportunities to exemplify the value of the field medical team to external audiences


• Support Data Generation Strategy (IIRs and Company Sponsored Phase 2- 4):
• Partners with Director of data generation to provide quarterly reports on key field scientific insights
• Develops informal surveys, insight tracking/collection platform that can be fed effectively into the data generation strategy.
• Serves as back up if Data Generation Director is out of office
• Creates and maintains field PI list for all clinical trials in the US. Partnering with phase 4 data gen lead to ensure all company sponsored trials have proper PIs, and partners with clinical operations to ensure pivotal trials have the proper US PIs to drive quick enrollment.
• Develop and support MSL directors to create a strong research focused field plan to engage top research centers. Create metrics to track the success of this.
• Provide leadership support as needed to Investigators currently involved in the sponsored interventional or observational studies and investigator-initiated research either directly or in collaboration with the MSL/MSL leadership to ensure alignment to the business scientific needs.
• Serve as a liaison between global clinical operations, Clinical development and other functions that need field medical support.
• Ensure the MSL team is properly trained on IIR topics of interest and understand the IIR process and execute IIRs appropriately per the company standards.


• Support Scientific Data Generation and Dissemination:
• Co-Develop with the MSL Director the strategy for scientific exchange with HCPs by fostering fair and balanced medical and scientific communications that are not misleading about clinical trials and commercialized products.
• Co-Develop with medical communications the medical education materials for the field to present product and clinical trial information to a variety of audiences (KOLs, HCPs, hospital/decision making teams, payers, internal teams).
• Co-Develop data dissemination plan for congresses in collaboration with medical communications for all IIRs and company sponsored trials.
• Develop medical information plan for field team in collaboration with medical communications for responding, within defined timelines and quality standards, to unsolicited inquiries from HCPs/PIs.
• Support the updating of FAQs for KAMs, MSLs and internal colleagues for all relevant prescribing information and therapeutic information including clinical trials.
• Cross functional support with global medical communications of publication plan for all prelaunch clinical data, development of abstract, poster and manuscript
• Cross functional support of publication plan for phase 4 clinical trials. Serve as field medical reviewer on publication committee.
• Lead Strategic Execution and Operational Excellence:
• Under the direction of the Global Head of Medical Affairs and Global lead for Medical Affairs strategy, work with key stakeholders, management, and functional area leads in the development and execution of key elements of the medical affairs strategy and tactics.
• Ensure all activities are conducted with the highest levels of scientific rigor and in full compliance with applicable rules and regulations.
• Responsible for all CRO activities for all ongoing phase 4 clinical trials in the US, including CRO selection, contract development and timeline execution. Hosting all check in calls and internal communication calls for trials.
• Development and management of clinical affairs and MSL team tactics aligning to the overarching medical affairs and clinical strategy.
• Communicate key medical insights from KOLs/PIs to inform refinement of clinical trials strategies and tactics.
• Lead field-based clinical research programs, registries, and facilitation of the investigator-initiated research process. Including protocol and contract review and approvals.
• Lead development and updates of all related SOPs and policies, ensure training is completed on all applicable SOPs and maintain training logs.
• Lead development and updates of team special projects, goals, and company KPIs.


• Company Cross Functional Leadership:
• Maintain awareness of and access to internal and external information sources and applicable cross functional areas to execute field medical activities.
• Maintain knowledge base and scientific expertise on all assigned disease areas and products and lead all pipeline related activities in that therapeutic area.
• Develop and update knowledge of applicable pharmaceutical guidelines and regulations. Code of Ethical Practices and company policies.
• Gain customer insights, opinions and feedback and share internally regarding present and ongoing clinical trials.
• Ensure execution of team special projects and cross functional support as needed for medical expertise of the team.
• Work cross functionally with medical communications and marketing partners to ensure aligned congress presence and objectives.
• Serve as the field based clinical expert on the cross-functional commercialization team and serve as the voice for the field based MSL team.
• Seek opportunities to provide MSL and MSL activity visibility across the company.
• Serve as backup as needed for Global Head of Medical Affairs or MLR review team.

MAIN AREAS OF RESPONSIBILITIES COMMON TO PEOPLE MANAGER (if applicable)

• Lead the field medical team (MSLs)
• Create goals yearly in partnership with direct reports, and as needed to ensure team is aligned to tactics defined in goals to harness successful execution.
• Support Global Medical Communications with the development of the US medical affairs strategy and create aligned tactics for field team.
• Ensure US field medical teams are meeting individual goals quarter over quarter.
• Conduct mid-year and end of year reviews for all direct repost.
• Host monthly field medical leadership team alignment calls.
• Assist the Global Head of Medical in team hiring, field training, evaluations, motivation, and performance enhancement activities in alignment with the company’s corporate strategies and objectives/KPIs.
• Work with direct reports to identify professional development goals and project opportunities.
• Partner and collaborate with cross functional Directors to ensure company is informed of key drivers from the field medical team.

EDUCATION

• An advanced degree in life sciences (MD, PharmD or PhD or equivalent)
• An MBA or advanced business degree is a plus

FURTHER REQUIREMENTS

• 7+ years of previous experience in Pharmaceutical/Biotech industry or equivalent clinical care setting
• 4+ years of successful management experience with strong skills in leadership, coaching and developing within Medical Affairs or equivalent
• 2+ years of demonstrative therapeutic experience/research or substantive patient care experience in Ophthalmics
• 2+ years working in startup company environment
• Experience in pre-clinical through clinical trials site selection, protocol development, contract reviews and negotiations
• Experience in RFP process for contracting/onboarding medical affairs vendors
• Experience in reviewing and developing medical affairs SOPs and policies
• Frequent travel is required, including international travel ~60% of time
• Availability to attend meetings on holidays and weekends, valid passport to travel internationally

RELATIONSHIPS WITH AREAS INTERNAL TO THE COMPANY

• R&D (Regulatory Affairs, Clinical Development, Drug Safety etc.)
• Medical Affairs (Med Info, Med Comm, Ops)
• US Commercial Marketing and Sales
• Field Marketing
• Operations (Medical and Commercial)
• Legal, Ethics and Compliance
• HR

RELATIONSHIPS WITH BODIES/COMPANIES EXTERNAL TO THE COMPANY

• Investigators (PIs)
• Key opinion leaders (KOL)
• HCPs
• Patient advocacy groups
• Regional policy makers
• Payers- Managed Care
• National and Regional Societies

SOFT SKILLS

• Excellent Communication
• Self-Motivation
• Leadership, Inspiring & Influencing
• Teamwork & Collaboration
• Cross functional Collaboration
• Problem Solving
• Decisiveness
• Time-Management

DOMPÉ VALUES

• Integrity
• Speed
• Knowledge
• Passion
• Attention to Detail
• Reliability
• Flexibility
• Teamwork

$195,000 - $285,000 a year

At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.