Chief Medical Officer
Elucida Oncology, Inc. is a Monmouth, New Jersey based biotechnology company committed to developing targeted C’Dot Drug Conjugates, or CDCs, for the treatment of cancer. Elucida Oncology is currently identifying lead CDC candidates and anticipates initiating clinical studies in mid-2021.
Elucida’s C’Dot platform has unique properties due to its ultra-small size and composition that enables CDCs to both rapidly target and penetrate tumors, even those in difficult to access regions like the brain, and to clear from the body primarily through the kidneys. Our CDCs are functionalized with multiple targeting ligands to promote tumor-targeting specificity and potent payloads via linkers designed to maintain their stability in the circulation and release in the tumor.
The Chief Medical Officer will report directly to the Chief Executive Officer. The primary role of the CMO will be to provide leadership and direction for Elucida’s pipeline of clinical development programs in the field of oncology. The CMO will be responsible for the strategy, direction and execution of the company’s clinical development plans. The CMO will be a key member of the management team which determines and oversees research and drug development at Elucida and sets the overall strategic direction of the company. The CMO will be a major contributor to the success of a well-positioned growth stage biotechnology company with an exciting and versatile platform.
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 for Elucida Oncology’s CDCs including working with the management team to identify indications where the platform has the greatest potential for success
- Manage the clinical aspects of regulatory strategies and interactions with the FDA
- Oversee CROs and Elucida employees focused on the clinical development of the CDC pipeline
- Lead the analysis and interpretation of clinical trial data and the reporting of clinical trial results
- Lead interactions with clinical and academic thought leaders, investigators, cooperative groups, and other 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
Education/Experience: The ideal candidate will offer:
- MD with Board Certification in hematology/oncology
- 15 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-III clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s and NDA’s)
- Knowledge of relevant FDA regulations and guidelines as well as those of the EU 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 Oncology drug development
- Experience or knowledge of Orphan or genetic rare disease drug development a plus
- Experience in translational medicine, clinical pharmacology and early stage development is desirable
- Excellent knowledge of the competitive environment for drugs in the Hematology/Oncology 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 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 with an 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.
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.
Elucida Oncology is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
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