Chief Medical Officer
New York
Permanent
$300,000 - $350,000
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Pre-IPO biotech company looking for an experienced Chief Medical Officer
Oversight of Regulatory Affairs, Clinical Development, and Medical Affairs
About Our Client
A global biotech company with innovative and proprietary technology platforms focusing on oncology and inflammatory diseases
Job Description
- Direct the development of clinical strategies and plans
- 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
- Ensure the highest quality and integrity across all aspects of clinical/medical information and communications; including but not limited to content for customer education, commercial clinical team, medical information requests and promotional review
- Strengthen engagement with medical community through various channels, including advisory boards, user meetings, CME programs, academic collaborations and professional societies. Build and maintain key opinion leader relationships consistent with commercial and development objectives.
- Establish the systems, processes and procedures to ensure safety and performance of marketed products.
- Work with the commercial team to design internal/external training programs and support the delivery of those training events as requested
- Collaborate with management to evaluate growth opportunities based on unmet clinical needs, emerging technology, and competitive landscape
The Successful Applicant
- MD with Board Certification in hematology/oncology with Oncology training preferred
- 15 years minimum experience in clinical development within 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
- 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
- Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other global 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 in translational medicine, clinical pharmacology and early stage development is desirable
- 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
What's on Offer
Excellent base and bonus package with long-term incentive equity once company goes public