Reporting to the Chief Executive Officer, the Chief Medical Officer will be a key member of the company's executive team, which determines and sets the overall strategic direction of the company. The CMO will work closely with the executive team and provide leadership and direction for all clinical development programs in the company's pipeline. The CMO will be responsible for the strategy, direction, and execution of the company’s clinical development plans.
Essential Duties & Responsibilities
- Responsible for all major phases of clinical development. Sets and directs the strategy for all clinical development activities. Establishes the conditions essential for determining the safety, efficacy, and marketability of product candidates.
- Directs and/or contributes to all therapeutic product profiles to guide translational, clinical, and commercial development plans.
- Directs and/or contributes to all companion diagnostic and biomarker strategies.
- Orchestrate and manage 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 leadership to the executive team to develop and communicate the overall corporate strategy.
- Active role representing the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners.
- Responsible for hiring and managing appropriate full-, part time-, and/or contract personnel, including leadership in clinical research, pharmacology, biometrics, clinical operations, regulatory affairs, and drug safety and pharmacovigilance, as appropriate and agreed upon with the executive committee.
- MD or equivalent with active board certification in hematology/oncology, rheumatology, immunology or other related sub-specialization.
- 15 years minimum experience in pharmaceutical and/or biotechnology industry experience developing investigational new drugs and leading and building clinical development organizations.
- Multiple years of management experience leading a clinical group including clinical/medical affairs, clinical operations, biometrics, regulatory affairs, and drug safety and pharmacovigilance.
- Proven success record of executing Phase I-IV clinical development programs including successful regulatory submissions of IND’s, BLAs, NDAs MAAs leading to successful marketing approvals
- Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA is essential; experience in interactions with other health authorities strongly desired.
- Experience with drug development in autoimmune and inflammatory diseases and/or oncology, and experience or knowledge of orphan disease drug development a plus.
- Proven experience in translational medicine, clinical pharmacology, and early-stage development.
- Excellent knowledge of the competitive environment for drugs in the autoimmune and inflammation, hematology/oncology, rheumatology, and related therapeutic areas.
Skills and Attributes:
- 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 the best fit, the candidate must have the ability and strong desire to be "hands-on." 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.
- Proven interpersonal and influencing skills. This includes a demonstrated ability to use an open and supportive communication style and to work cross-functionally with multiple corporate sites, teams, and personalities.
- Commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards.
- An entrepreneurial, innovative, energetic, hands-on, team-oriented, and customer-focused, attitude, and approach.
- The ability to think strategically as well as execute project details.
- Ability and strong desire to work in a dynamic “start-up” environment and be able to travel domestically and/or internationally.