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

• A minimum 7+ years Pharmaceutical Industry experience and at least 5 years of relevant work experience in the US and in the pulmonary hypertension (i.e. PAH, PH-ILD, PH-COPD) therapeutic area
• Demonstrated ability to think and act strategically, with demonstrated tactical execution.
• In-depth knowledge of Pulmonary Hypertension (i.e. PAH, PH-ILD, PH-COPD) with expert insight to drive the disease vision through rigorous scientific debates with medical thought leaders.
• Ability to influence, work and align with multiple Chiesi-internal and external stakeholders, and navigate within cross-functional Chiesi teams.
• Experience working with alliance partnerships and co-promotion setups, effectively navigating collaborative relationships to drive brand success.
• Prior experience working on a launch product for pulmonary hypertension (i.e. PAH, PH-ILD, PH-COPD) is preferred.
• Understanding of HCP, Payer, and Policy Maker informational needs and what is required to support them, including promotional review boards or committees.
• Proven planning and organizational skills with great attention to detail as well as the ability to prioritize in a changing environment with a sense of urgency.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols is preferred.
• Well-organized, operationally effective, and able to both develop project strategies and ensure reliable implementation of projects with a flexible and solution-driven attitude.
• Strong interpersonal skills in developing and maintaining successful stakeholder relationships (internal and external)
• Excellent written and oral communication skills.
• Understanding of global markets, including ROW regulations and market dynamics, to inform medical strategy.
• Innovative thinker with a passion for adopting emerging technologies.

Education

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