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 the organisation's pipeline of clinical development programs. The CMO will be responsible for the strategy, direction and execution of the company's clinical development plans.
Entrepreneurial; excited by new challenges and not intimidated, but instead invigorated by the ambiguity and risks associated with an 'early-stage' endeavour.
A predisposition to roll-up-the-sleeves and personally engage in the work at hand; comfortable working in the resource-constrained, fast-paced environment of early-stage companies.
Essential Duties and Responsibilities:
- Accountable for developing and executing the medical and clinical development strategy throughout the development life cycle
- Oversight of Development Plans and supervision of medical and scientific experts in clinical development, medical affairs, and pharmacovigilance.
- Close collaboration with internal experts (regulatory, CMC, commercial, medical affairs, program management) and external government agencies, DMCs, scientific networks and KOLs on delivering successful development programs, registration and reimbursement dossiers
- Medical representative of the company during BD&L activities and investor interactions
- Participation in the executive management team of the company
- Direct the development of clinical strategies and plans to integrate organisations compounds into the standard practice of neonatology, immunology, and rare diseases
- Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities
- Accountable for the design, implementation, safety, and data quality for all company sponsored clinical studies
- Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results Chief Medical Officer
- 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
- MD with Board Certification in haematology/oncology or Paediatrics with Oncology training preferred
- 15 years minimum experience or equivalent 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 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 neonatology 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 Immunology/rare disease 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.