Scientific Director, Medical Affairs - Respiratory
Cary, NC, US
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."
Purpose
The primary responsibility of this role is the execution and implementation of the US Medical Affairs strategy for Trimbow, including internal and external engagement, generation of clinical and scientific data, and oversight of educational initiatives. This role works closely with sales, marketing and the commercial teams to provide strategic medical input into product strategies, and to support medical and marketing activities and market access. He/she supports successful medical launch and product commercialization, while putting the patient first within the Chiesi Values and Behaviors framework.
Main Responsibilities
Strategy- Contributes to the development of brand strategies. 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. Oversees the US Conference planning and execution.
Medical/Legal/Regulatory Review- 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.
Evidence Generation- 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.
Medical Information- Contributes to the generation of MI communication content and supports training on Medical Information (MI) materials. Generates clinical and scientific data as well as data on file (DOF) as needed to support external communication.
Matrix Partnership- As appropriate, participates in Medical Affairs Respiratory Team consisting of cross-functional medical colleagues including provides medical input on US labeling and regulatory interactions.
Experience Required
• At least 5 years of relevant work experience in the respiratory therapeutic area; experience in Medical Affairs with increasing levels of responsibility preferred.
• Demonstrated ability to think and act strategically, with demonstrated tactical execution.
• In-depth knowledge of respiratory diseases 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.
• 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)
• Prior experience working on a launch product in a respiratory disease is preferred.
• Excellent written and oral communication skills.
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.
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