The Head of Clinical Research and Development will report to the CMO and will be responsible for leading clinical strategy and development across the Beyond air program portfolio. This role will provide medical oversight for studies with a focus on safety. This role oversees data generation in house and with CROs and collaborators meeting the highest standards scientifically and ethically to enable highly effective regulatory interactions. This individual will lead the clinical development programs for branded products, as well as provide key subject matter expertise to portfolio expansion and business development opportunities.
- Responsible for the preparation of the Global-initiated clinical development plans, medical input to Investigator’s Brochures, study protocols, study reports, clinical components of IND/IDE and NDA/PMA applications.
- Establish and assess the strategy for clinical trial planning, design, execution, and analysis with assurance of alignment with regulatory activities.
- Contribute to assessment of medical safety in clinical trials
- Coordinate with Regulatory Affairs to ensure adequate input into clinical dossiers and labelling matters. Participate in FDA and Scientific Advisory Committee meetings. Provide annual IND clinical updates.
- Lead a team focused on the clinical development programs associated with the branded products and business development opportunities.
- Advise clinical team on protocol development and execution
- Interact with internal and external stakeholders for the clinical strategy and study operations, inclusive of external engagement with consulting healthcare professionals, trial site investigators, Contract Research Organizations, and other vendors.
- Identification and maintenance of key resource support to the clinical project managers for study execution, project management, program management, data integrity, and medical writing.
- Accountability for Clinical R&D compliance with policies, procedures, and standard operating procedures.
- Evaluate and contribute to potential business development opportunities.
- Attend, and if relevant, lead in training curricula, symposia, and conferences in order to maintain medical and leadership expertise associated with Clinical R&D’s goals and objectives.
- Communicate effectively with partners, affiliates, and stakeholders to ensure alignment and time-bound clinical and business commitments.
- Adhere to Good Clinical Practice (GCP) and assure the adherence of all clinical team members (internal and external) to GCP.
- Work closely with functional partners to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s)
- Regularly interact with cross-functional teams to provide input on strategic clinical development issues and clinical trial operations relating to R&D projects.
- Serve as the clinical representative to lead key regulatory discussions
- Ensures adherence to Good Clinical Practices, standards, standard operating procedures and to all other quality standards in conducting research
- Develop high quality and relevant real world evidence data that demonstrate clinical, economic, and humanistic value to healthcare decision-makers.
- Ensure Medical, R&D, and cross organizational alignment on publication strategy.
- Demonstrate a high level of credibility with external KOLs, and internal stakeholders to identify tactical gaps in strategy and utilize understanding of clinical trial design, statistical methods, and clinical data to develop studies and communicate their results to address those deficiencies.
- Driving the medical writing strategy for all clinical programs, and for the provision of managerial oversight
- Leads cross-functional teams to develop a medical communication strategy
- A minimum of 10 years of experience in clinical research.
- MD/PhD/PharmD required
- Requires proven experience with developing efficient discovery processes and directing complex cross-functional team collaborations.
- Must have a proven track record of advancing programs through discovery, IND-enabling studies and IND filing.
- Demonstrated expertise in therapeutic development process including technical, business, and regulatory issues.
- Evidence of successful ongoing career development and leadership skills; additional Medical, Safety, or other pharmaceutical development experience is preferable. Experience as a project team leader with major responsibility for at least one New Drug Application (NDA) or equivalent device submission desired
- Experience in leading discussions with FDA and other health authorities at all phases of development
- Requires the ability to build strong relationships with key stakeholders.
- Excellent scientific writing and editing as well as written/oral communication skills with several years of professional experience in medical or scientific writing (clinical protocols)
- Experience managing CROs and working within cross functional teams
- Self-starter with ability to learn new disciplines
- Strong analytic skills, problem-solving skills, and medical writing skills. Experience in writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis, and presenting data to internal and external audiences.
- Ability to think strategically and communicate/problem-solve within a team structure.
Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.