Job Title: Chief Medical Officer
Reports to: Chief Executive Officer
Longeveron (NASDAQ: LGVN) is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company’s mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization, and broad use by the healthcare community.
We are seeking a dynamic and experienced professional to grow with our team as Chief Medical Officer (CMO). Now is an exciting time to join Longeveron. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. Our work atmosphere is fast paced, stimulating, team based and results oriented.
The primary role of the CMO will be to provide leadership and direction for Longeveron’s pipeline of clinical development programs in chronic aging-related diseases and conditions and other life-threatening conditions. The CMO will be responsible for the strategy, direction and execution of Longeveron’s clinical development plans. This is a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth stage biotechnology company.
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform the following:
• Direct the development of clinical strategies and plans to move Longeveron’s investigational products through Phase 1 – 3 clinical trials with the goal of commercialization
• Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities
• Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
• Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders
• Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
• Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners
• In addition to building, leading and supervising the Clinical Research Department the CMO will have direct line responsibility for the Clinical Operations, Patient Advocacy, Medical Affairs, and Biostatistics departments/personnel.
• MD with Board Certification
• 10+ years minimum experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs.
• Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations
• A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s)
Knowledge, Skills and Abilities:
• Knowledge of relevant FDA regulations and guidelines as well as those of the EU, Japan, and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus
• Experience with, or strong knowledge of neurology drug development
• Experience or knowledge of Alzheimer’s disease and geriatrics/gerontology/geroscience drug development a plus
• Experience in regenerative medicine, cell and gene therapy development is desirable
• Excellent knowledge of the competitive environment for therapeutics in the neurology and geriatrics marketplace and in research and development pipelines
• Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
• The successful candidate will read, write and speak fluent English, possess excellent communication skills and will be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community.
• Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence.
• Must be science- and data-driven
• For best fit, the candidate must have the ability and strong desire to “make things happen”.
• Must have a results-oriented work ethic and a positive, can-do attitude. Effective leadership, people management, communication skills and a team builder management style are essential; must be willing and able to be “hands on”.
• Must have the highest personal values and ethical standards.
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 30% or more of time.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Commensurate with experience. Eligible to participate in equity incentive plan, retirement plan, healthcare benefits, paid time off and discretionary bonus.
Longeveron Inc. is dedicated to a diverse workforce and Drug Free work environment.
Qualified candidates are encouraged to apply.
Please send Cover Letters, Resumes and/or CVs to email@example.com