Senior Director, US & LATAM Field Medical Affairs

Job Summary

This position provides subject matter expertise and supports the VP Medical Affairs on the overall Medical Affairs strategy, with focus on the US. The Senior Director plays an integral role in coordinating the US Medical Affairs activities with particular emphasis on the support of the clinical development programs and is a key contributor to the overarching engagement strategy, collaborating with relevant external (HCPs, strategic alliances etc.) and internal stakeholders of the franchise. With focus in the US, this position is responsible for the overall strategic management of the MSL director(s) and team. This role will oversee, lead, and evolve the MSL organization by working with the Director(s) of the MSL team on territory and account planning and by providing leadership and strategic direction to the MSL team to ensure adaptation and execution of the relevant Medical Affairs and organizational plans, and will be an effective internal cross-functional partner.  The Sr. Director works with the Director(s) of the MSL team, clinical operations and clinical development to support cross functional initiatives designed to increase enrollment, ensuring that communication and positioning is targeted to the specific sites for maximum impact and tailored troubleshooting.

This position is further a key contributor to advisory board meeting strategy, planning and execution, as well as publication strategy and congress planning to ensure objectives and messaging are aligned with the overall medical affairs and organizational goals.

This position is the key contributor to the Medical Affairs prelaunch and launch strategy and the corresponding Medical Affairs plans ensuring launch readiness in collaboration with other functions internally and externally, specifically in close exchange and alignment with all commercial functions; including KOL engagement to gain an excellent understanding of market positioning through interface with the clinical and commercial organization. The Sr. Director, Medical Affairs supports the VP Medical Affairs and Medical Affairs communication colleagues on the scientific platform and messaging in coordination with clinical and commercial departments. This position also partners with patient advocacy to ensure messaging and activities are aligned with Medical Affairs and company strategy.

Essential Duties and Responsibilities 

• Lead Medical Science Liaison Function in the US.
• Work with the ROW MSLs Leadership and team and the global trainer on training plans, training needs, materials development for training and field use, and field coaching needs within and across the overall MSL team.
• Work closely with the Director MSL’s, clinical operations and clinical development to ensure alignment as it pertains to clinical study sites, communications and enrollment plans and activities.
• Provide analysis of clinical trial site activities, patient enrollment tracking and performance metrics and in conjunction with the Director of MSL’s, clinical development and clinical operations to identity enrollment success and challenges.
• In collaboration with Director MSL’s, clinical operations and clinical development, identify, communicate, and escalate critical issues, risks, lack of site responsiveness with a plan-of-action including deploying resources to address/mitigate.
• In collaboration with Medical Affairs VP, Sr Directors and directors facilitate overall Medical Affairs planning and provide guidance/recommendations to ensure alignment with medical affairs and company strategy and goals; develop and track timelines, monitor status, prioritize tasks and alert team to potential risks or concerns and support appropriate triage.
• Work with VP and Directors of Med Affairs on thought leader and HCP engagement through planning and execution of Advisory Board Meetings, round tables etc., and ensure alignment with key Gossamer Bio functions on strategic messaging. Lead strategic conversations and liaise with external stakeholders to strengthen Gossamer's medical reputation in the disease-state community.
• Attend regional, national and international conferences on Gossamer’s behalf to provide and solicit feedback on current landscape, competitive landscape and for continued cultivation of relationships.
• Educate the PAH, PH and IPF/ILD communities & create awareness of Gossamer and its ongoing clinical studies, with particular focus on phase 3.
• Provide leadership and strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. In collaboration with VP identify all strategically important events and facilitate alignment of functions around participating and key messaging; ensure approval.
• Work with key stakeholders, management, and functional area leads to develop strategic and aligned Medical Affairs Plans for the therapeutic area. Continuously update plans and inform stakeholders of progress.
• Prioritize and map critical activities and line success factors and the corresponding key tactical objectives needed to achieve goals.
• Work closely with patient advocacy consultants on strategy, messaging, and review of materials.
• Facilitate development and cross functional review of IIS strategy in line with company policies.
• Provide medical expertise and direction on key internal business processes including leading and/or active participation in relevant medical review committees.
• Contribute to the Medical Affairs prelaunch and launch strategy and corresponding plans ensuring launch readiness in collaboration with other functions internally and externally, particularly with internal commercial colleagues,
• Participate in special projects and assignments as needed.

JOB QUALIFICATIONS

Education, Certifications, Experience

• Advanced scientific or clinical degree (e.g. PhD, PharmD, MD) strongly preferred; equivalent experience may be considered.
• Minimum of 12 years or more of prior Medical Affairs experience preferred.
• Prior MSL experience required
• Current or prior experience in the PAH and/or PH field required and/or demonstrated aptitude to develop technical expertise in new therapeutic area(s)
• Experience with relationship building and expanding a company’s reach.
• Working knowledge of the clinical trial process and important study milestones, including early study planning, study start up, study execution and closure (e.g. IRBs, contracting, site feasibility, site initiation, etc.)
• Adaptability to changing landscape and ability to pivot quickly as new information becomes available.
• Experience with clinical research and early-stage products preferred.
• Demonstrated leadership and driving results in support of company objectives, in accord with company’s culture and values, including: respect, accountability, leadership, innovation, and collaboration.
• Excellent project management skills and ability to handle a number of different events at any one time. Must be flexible and able to work under pressure
• Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific and clinical expertise, and effective follow-through on requests from thought leaders.
• Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building.
• Strong analytical and problem-solving skills
• Ability to work effectively in a cross-functional environment.
• Must be proficient in creating high-end visuals in communicating scientific concepts.
• Office environment / Domestic and International travel up to 40% may be necessary.

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.