Medical affairs Jobs in Raleigh, NC

Who we are looking for

Purpose

The primary responsibility of this role is to lead the development, execution, and implementation of the global Medical Affairs strategy for Seralutinib within the US market in partnership with Gossamer Bio, our Alliance Partner. This includes internal and external engagement, generation of clinical and scientific data, pre-launch activities, publication planning and oversight of educational initiatives. Additionally, this role involves a key partnership and co-creation with the ex-US (ROW) Medical Affairs Head for Seralutinib to shape and align the global medical affairs strategy. The individual is accountable for building the bridge between global strategic considerations and ROW input, ensuring the strategy effectively addresses the distinct needs and regulatory landscapes of both the US and ROW markets.

The role works closely with sales, marketing, and other commercial teams to provide strategic medical input into product strategies, and to support both medical and marketing activities and market access. The individual is responsible for supporting the successful medical launch and product commercialization, always prioritizing patient care within the Chiesi Values and Behaviors framework.

Ideal candidate will be located in North Carolina to work a hybrid model out of our Cary, NC office.

Main Responsibilities

• Drives the development and execution of the global medical strategy for Seralutinib in close partnership with the alliance partner and the ROW Medical Affairs Head.
• Incorporates insights from the ROW Medical Affairs Head to ensure the global strategy is comprehensive and reflective of ROW market perspectives.
• Aligns medical and scientific initiatives with Scientific Communication Platform and contributes to the development of and execution of the Medical Education, Advisory Boards and External Engagement Plan.
• Partners with the ROW Medical Head to co-create, integrate, and complement these initiatives with ROW efforts.
• Oversees the US Conference planning and execution.
• Map Patient Journeys for Seralutinib in the US, identifying key patient needs and apply the framework to the possible solutions, collaborating with commercial, market access, and the alliance partner.
• Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.
• Co-Leads the development of the global evidence generation plan, partnership with the Alliance Partner and the ROW Medical Affairs Head to integrate insights from ROW markets.
• Contribute to the Investigator Initiated Study (IIS) and educational grants strategy and reviews and makes recommendations regarding submitted proposals, and where necessary Chiesi USA sponsored studies.
• Co-leads the global publications strategy alongside the alliance partner, while developing a tailored publication plan for the US. The ROW Medical Head will provide insights for complementing the publication strategy for the ROW market needs.
• Participates in the Medical Affairs Respiratory Team, providing medical input on US labeling and regulatory interactions.
• Collaborates with clinical operations and teams to support US clinical studies and aligns with the ROW Medical Affairs Head on global development.
• Acts as an active member of the Core Team conducting medial activities and planning for the US in partnership with the alliance partner.
• Single Point of Contact for Gossamer Medical Affairs : Acts as the primary liaison between Chiesi and Gossamer, ensuring alignment and fostering collaboration.
• Develops and implements effective alliance processes for medical affairs.

Experience Required

Education

Completion of a graduate level degree (PharmD, MD, DO, DNP, PhD, MSN, MS)

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business.  All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.