The Chief Medical Officer (CMO) plays a critical role in the design, planning, strategy and execution of the clinical programs and activities conducted as part of the Company’s product development portfolio. The Chief Medical Officer will initiate and conduct studies with high scientific integrity and is accountable for managing the overall clinical operational activities, data analysis and interpretation of results. The Chief Medical Officer will provide medical leadership and content expertise to ensure successful completion of all clinical programs.
WHAT YOU WILL DO FOR NOVEOME
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Research therapeutic indications and provides input into the scientific and clinical strategy for product in development in CNS and neuro-ophthalmology. Responsible for the development of Clinical Development Plans to include timelines, budgets, and resource requirements.
- Coordinates the operational aspects of development and delivery of study protocols, informed consents, study plans, and quality initiatives necessary to conduct in CNS and neuro-ophthalmology clinical trials. Reviews tables, listings, graphs and subsequent clinical study reports of completed studies.
- Reviews clinical study reports and summaries for regulatory purposes.
- Manages and troubleshoots the clinical development studies from a compliance and standardization perspective using regulatory references and guidelines.
- Acts as medical monitor to provide safety guidance and ensure compliance with Good Clinical Practices (GCP) and applicable regulatory guidelines within clinical programs and functional areas.
- Possesses an understanding of the complex interface between pre-clinical development, clinical research, and product development and uses this knowledge to provide input when establishing new processes, work instructions, and Standard Operating Procedures (SOPs) to ensure the effective and efficient execution of clinical operations.
- Drafts medical communications with the Food and Drug Administration (FDA) and other health authority agencies. Develops and maintains professional relationships with key opinion and thought leaders. Organizes and leads advisory boards when necessary.
- Leads and collaborates effectively with cross-functional management teams and external partners while leading indication project team meetings.
- Supports the development of scientifically accurate medical communication by authoring, editing and/or presenting abstracts, manuscripts, presentations and other scientific communications on behalf of the Company.
- Participates in grant writing and review as needed to support clinical projects.
- Supports business development efforts by performing clinical assessments on relevant discovery or late stage products.
Please note, as a company rooted in innovation, our positions are consistently evolving, and we champion the development of all roles. This job description is not designed to contain comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.
- CNS and Neuro-Ophthalmic physician leader in eye diseases
- Experience in all phases of eye disease and CNS and neuro-ophthalmology drug development
- Experience leading products through clinical trials to FDA approval and commercialization
- Experience designing successful clinical trials
- Experience in companies with multiple pre-launch and/or launched pharmaceutical products
- Management of CROs
- Clinical Trial Management Software (CTMS)
- Understanding of Medical Terminology
- Experience reviewing/writing eCTD sections
- Financial acumen in creating and managing large clinical program budgets
- Knowledge of safety and pharmacovigilance requirements
- ICH, GCP, EMA guidelines, and US FDA regulations
- Microsoft Office applications: Word, Excel, PowerPoint, Project
- Experience in US/Ex-US Expanded Access Programs (EAPs) and Investigator-Initiated Studies
- Successful project registration in the United States
- Experience with FDA and advisory committee meetings
- BLA submission experience
ATTRIBUTES OF SUCCESS
Communication, Strategic, Collaboration, Leadership, Innovation, Credibility, Self-Motivating, Goal Oriented, Entrepreneurial, Integrity
WORK ENVIRONMENT/PHYSICAL DEMANDS
Annual travel from office location to clinical sites and other areas as needed is about 10-20%. The majority of the work is conducted in a temperature-controlled office environment or clinical environment, subject to extended periods of sitting or standing. The majority of the work is sedentary requiring a proficiency in speaking, comprehending, and reading English, and vision to computer monitor.
This is a salaried exempt regular full-time position. Extended hours may be needed on occasion to complete Company objectives.
ABOUT NOVEOME BIOTHERAPEUTICS, INC.
Noveome Biotherapeutics, Inc. is a clinical stage biopharmaceutical company with an innovative platform technology that represents a paradigm shift in the development of novel therapeutics. Unlike most drugs that are single molecules/single targets, Noveome’s product is a complex mixture of biomolecules that is believed to have the ability to address a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.
WHAT NOVEOME WILL DO FOR YOU
Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment. Eligible employees will appreciate the comprehensive benefits package and wellness perks.
REPORTS TO: MEDICAL AFFAIRS EXECUTIVE VICE PRESIDENT
MANAGERS OTHERS: YES
EDUCATION REQUIREMENTS: DOCTORATE OF MEDICINE WITH A DEGREE IN A RELATED SCIENTIFIC DISCIPLINE
RELATED DEGREE PROGRAMS: BIOLOGY, MICROBIOLOGY, CHEMISTRY, OPHTHALMOLOGY & CENTRAL NERVOUS SYSTEM
YEARS EXPERIENCE REQUIREMENTS:
- 10+ YEARS IN AN FDA REGULATED BIOPHARMACUTICAL INDUSTRY
- 8+ YEARS CLINICAL DEVELOPMENT/PROJECT MANAGEMENT EXPERIENCE
- 4+ YEARS CNS and NEURO-OPHTHALMOLOGY INDUSTRY EXPERIENCE
A combination of experience and/or education will be taken into consideration.
Noveome is an Equal Opportunity Employer.