Director Real World Evidence Jobs in Raleigh, NC

About Aerogen Pharma:
Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.
We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.
Join us as we embark on this breakthrough and become inspired to deliver.
What is the role?
This Medical Director, under the direction of the Chief Medical Officer (CMO), provides medical and scientific leadership for Aerogen Pharma's clinical development programs, ensuring alignment with corporate strategy and compliance with all regulatory, ethical, and scientific standards.
This role will have direct medical oversight with our ongoing Phase 3 clinical program, with engagement with internal clinical operations team, site and country level principal investigators, study coordinators, respiratory therapists and all associated vendors. In addition, this role will contribute to the design and execution of the synthetic surfactant global clinical development program
You will execute and oversee clinical programs across the product lifecycle, including early- and late-stage development, post-marketing activities, and real-world evidence initiatives, to support business objectives and regulatory submissions.
This role works closely with stakeholders across the business to accomplish delivery of product driven initiatives, build and develop enduring peer-to-peer relationships with healthcare professionals and institutions creating constructive, cross-functional partnerships with internal and external stakeholders. In addition, preparation of scientific presentations/talks, responsibility for internal and external medical publications, and clinical sections of regulatory documents will be a key responsibility.
What are the key responsibilities?
• Lead the clinical and medical strategy for assigned development programs, translating scientific and pre-clinical evidence into clinical development plans and providing medical leadership for study design, execution, interpretation and communication of results.
• Provide medical leadership and oversight of clinical study execution, including protocol development and implementation, eligibility and clinical issue resolution, medical data review, and cross-functional decision-making, in close partnership with Clinical Operations and other functions.
• Lead the clinical and medical aspects of first-in-human development and readiness, including translational assessment, dose and escalation strategy, stopping criteria, biomarkers, safety considerations, protocol development, and clinical contributions to IND/CTA submissions.
• Provide ongoing medical monitoring and clinical safety oversight, including review of emerging safety and efficacy data, identification and escalation of potential trends or signals, and assessment of evolving benefit-risk, in close collaboration with Pharmacovigilance.
• Serve as the clinical subject-matter expert for assigned programs, leading medical and clinical contributions to regulatory strategy, briefing documents, submissions, regulatory interactions and responses to health authorities.
• Develop and maintain trusted scientific relationships with investigators, KOLs, healthcare institutions and other external experts, using external insights to inform development strategy while representing Aerogen Pharma credibly within the neonatal medical and scientific community.
• Build and sustain credible, peer-to-peer scientific relationships that enhance Aerogen Pharma's presence within the medical and scientific community.
• Contribute to safety oversight activities, including review of adverse events, risk management plans, and benefit-risk assessments in collaboration with Pharmacovigilance.
What education and experience are required?
• Neonatalogist (MD) with 5+ years of post-fellowship clinical practice experience with experience to independently lead clinical studies.
• Experience in biotech/pharmaceutical company environment strongly preferred.
• Neonatal clinical trial experience, including study design, implementation, management, and analysis
• Preferably has served as PI or Co-PI on neonatal clinical trials.
• Experience in designing data collection tools (case report forms, study databases) strongly preferred.
• Experience as DSMB and/or IRB/Ethics Committee member is a plus
• Experience in leadership position(s) within Division, Department, or Hospital is a plus
• Experience contributing to or implementing Investigator's Brochures, protocols, CSRs and responses to regulatory and/or ethics questions.
• Experience Authoring clinical sections of briefing documents and regulatory applications
• Experience with translation of pre-clinical models into clinical study, protocol and safety monitoring design.
What key skills will make you great at the role?
• Proven ability to engage effectively with KOLs, investigators, and healthcare institutions.
• Knowledge of pharmacovigilance processes, risk management, and benefit-risk assessment.
• Thorough understanding of compliance requirements and industry codes of practice.
• Strong cross-functional collaboration skills across Clinical, Regulatory, Safety, Commercial, and R&D teams.
• Hands on, results oriented with strong initiative, accountability and willingness to take ownership and drive projects to completion.
• Demonstrated strategic capability and ability to see the overall, 'big' picture, along with examples of showing courage and confidence to develop, lead and implement change across disciplines.
• Strong written and oral communications skills.
• Preference for location near Raleigh, North Carolina. Candidates in San Mateo California will also be considered.
• Must be available for Travel within US, up to 30% of time.
Why Aerogen Pharma?
As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.
We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.