Regional Medical Affairs Manager Sr. Regional Medical Affairs Manager
Há 9 horas
Summary The Regional Medical Affairs Manager / Sr Regional Medical Affairs Manager will be responsible for facilitating scientific exchange and clinical support for Gossamer’s clinical studies and will engage with clinical study sites investigators and study personnel to encourage fast study start‑up, identification of patients, and enrollment efforts in Gossamer Bioscience company sponsored studies. Essential Duties and Responsibilities Strategic & Scientific Leadership Demonstrate deep scientific expertise in pulmonary hypertension (PAH / PH‑ILD) and related therapeutic areas to inform strategy and external engagement. Distill feedback from healthcare providers (HCPs) and investigators into actionable insights to shape cross‑functional strategy. Contribute to the development of medical and scientific materials ensuring accuracy, high quality and alignment with corporate standards. Participate in advisory boards, internal project teams and therapeutic area strategy discussions. Execute strategic medical affairs initiatives in support of department priorities as assigned by management. Function as lead on assigned projects within medical affairs (competitive intelligence, Veeva Journal Club, etc.) External Engagement & Relationship Building Develop and maintain trusted relationships with principal investigators, key opinion leaders (KOLs), advocacy groups and other external experts. Educate and support clinical sites on trial protocols, enrollment and patient retention in collaboration with Clinical Operations. Deliver high‑quality scientific and educational presentations to diverse audiences. Represent the company at national/regional congresses, symposia and scientific meetings gathering insights on the competitive and treatment landscape. Serve as a liaison between the scientific community and the company to enhance understanding of scientific foundations and goals for approved, in‑development and active trials sponsored by the company and its partners. Cross‑Functional Collaboration Partner with Medical Monitors, Clinical Development Leads, Clinical Operations and Medical Science Liaisons (MSLs) to ensure coordinated trial and field execution. Support HCP and site staff education on clinical protocols and the scientific rationale. Contribute to the development and execution of strategic KOL engagement plans. Provide medical and scientific support in response to unsolicited questions from HCPs, payers and decision makers. Provide therapeutic area expertise to cross‑functional partners (Marketing, Sales, Market Access, etc.) Collaborate with partners on medical affairs projects that are co‑branded. Education Insights & Value Delivery Coordinate scientific education initiatives for external stakeholders including advocacy groups and HCPs. Provide clinical and economic value information to payers and formulary decision makers. Gather and communicate competitive intelligence, research developments and treatment advances to internal stakeholders. Compliance & Administration Ensure timely, accurate completion of administrative reports and documentation. Provide guidance on the investigator‑initiated study (IIS) process and facilitate communication of review outcomes. Ensure all medical activities adhere to regulations and promote ethical standards. Consistently model company values fostering openness, innovation and collaboration. Job Qualifications Advanced scientific or clinical degree (PhD, PharmD, DNP, MD, DO or equivalent strongly preferred). Minimum 2 years of experience in a field‑based Medical Affairs role; experience in PAH and/or PH‑ILD strongly preferred. 5 years of experience required for a senior level. Broader experience in cardiovascular, pulmonary, transplant or critical care will be considered. Clinical trial experience required with strong understanding of trial design, site operations and enrollment dynamics. Experience with pre‑launch, launch and post‑launch activities. Proven ability to build and sustain relationships with principal investigators, KOLs and other external experts to support clinical trial execution and scientific exchange. Demonstrated ability to translate complex scientific data into clear, impactful communications for a range of stakeholders. Strong analytical skills with the ability to collect, distill and communicate medical insights that shape cross‑functional strategy. Strong organizational skills able to manage competing priorities and timelines in a dynamic environment. Strong presentation and teaching skills with the ability to tailor content to audience needs and facilitate discussions. Excellent communicator skilled at diplomacy and capable of combining scientific expertise with relationship building. Adaptability to a changing scientific and clinical landscape; ability to pivot strategies as new information emerges. Collaborative mindset with demonstrated success working across Clinical Development, Clinical Operations, Commercial and other internal partners. Self‑directed with a strong leadership presence able to represent the company at conferences, advisory boards and other scientific forums. Ability to work independently and manage multiple responsibilities both internally and externally. Must be willing to travel extensively including occasional weekends. Office environment / Domestic and International travel up to 75% may be necessary. Territory encompasses a broad geographical area across Brazil and potentially surrounding LATAM regions. Candidate must reside in Brazil. Required Experience Manager level Key Skills Proofreading Adobe Acrobat FDA Regulations Manufacturing & Controls Biotechnology Clinical Trials Research & Development GLP cGMP Product Development Chemistry Writing Skills Employment Details Employment Type: Full Time Experience: years Vacancy: 1 Equal Opportunity Statement 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. #J-18808-Ljbffr
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