Job Description
Job Type
Full-time
Description
The Chief Medical Officer, "CMO" will work as a strategic partner with other members of the senior executive team to develop and advance their clinical development strategy and drive the clinical research vision and regulatory roadmap for the company. The CMO will have over-arching responsibility for the successful clinical development of the Company's pipeline programs and will be the external "face" of the company for clinical research and development opportunities, interacting with principal investigators, key opinion leaders, and potential pharmaceutical partners. S/he will represent the company with regulatory agencies and meet with members of the investment community.
The CMO will direct the development of clinical strategies and programs, formulating standards and policies to maximize the potential for success of compounds under development. Primary responsibilities will include developing a target product profile and development plan, executing clinical trials, coordinating with clinical research organizations and other vendors, developing and managing clinical advisory boards, broadening the internal clinical research capabilities, and overseeing all clinical collaboration efforts with partners, principal investigators, and key opinion leaders.
Key Responsibilities - Provide insight and guidance with respect to all clinical and medical needs for the strategic direction and new business opportunities across the varied segments of interest for the Company.
- Provide oversight and leadership of the various functional areas within clinical operations, clinical science, medical monitoring, and regulatory affairs consistent with development goals across the company's portfolio.
- Drive execution of clinical trial plans to deliver compelling safety, pharmacokinetic, and efficacy data supportive of regulatory and marketing proof-of-relevance.
- Help prioritize target markets/indications for development.
- Research and identify new opportunities and novel therapeutic opportunities that augment the company's mission, vision, values, and goals
- Establish and maintain relationships with principal investigators, consultants and KOLs to ensure that the Company has a clear understanding of clinician needs and requirements, as well as medical practice patterns.
- Represent and manage the Company's clinical and regulatory programs to diverse audiences including: FDA or EMA, corporate partners, Board of Directors, professional societies and other key stakeholders.
- Act as a liaison for the Company with other pharmaceutical companies and partners to identify and implement collaborative studies, regulatory activities, and other programs.
- Participate as a member of the Safety Monitoring Board.
- Review study publications for scientific and medical content.
- Identify and provide guidance on opportunities to jointly publish / present scientific and medical data in collaboration with partners and investigators.
- Attract and retain a highly skilled clinical development team.
- Maintain an understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and tracking literature.
- Actively assist in seeking product and/or technology alliances with appropriate pharmaceutical company partners to enhance/expedite the development of the company's assets.
- Help to establish and maintain collaborations with partners in academia, government, and industry.
Requirements
- Board Certified MD/PhD, or MD with medical research and drug development experience.
- 10+ years of relevant industry experience in either the pharmaceutical or biotechnology industries with specific experience in the area of oncology is desirable.
- Subject matter expert with exceptional command of medical literature in oncology and related disciplines. Highly developed understanding of the external marketplace to identify long-term benefits for unmet customers' and patients' needs.
- Prior experience in global clinical development of small molecule products, ideally across all phases with emphasis on Phase 1 through Phase 3 clinical studies.
- Demonstrated capabilities leading clinical program(s) to successful filing and approval in both US and globally.
- Broad medical, scientific, regulatory, and technical knowledge of most functional areas involved in clinic development.
- Prior experience in leading interactions with the FDA and knowledge of FDA/EMA GCP clinical requirements.
- Experience in managing a regulatory affairs organization a plus.
- Credibility within the international medical and scientific community. Solid professional relationships with key opinion leaders in oncology fields are desirable.
- Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders. Ability to develop strong positive relationship with senior management and Board of Directors. Ability to provide leadership and guidance to a high functioning clinical and regulatory team.
- Experience presenting to a wide variety of audiences including internal teams, board of directors, investors, medical and scientific communities.
- Solid management skills and a good reputation for managing others to succeed.
Salary Description: $350k-$470k
Salary Description
$350k-$470k
Job Tags
Full time,