Job Description

About the Company : The Chief Medical Officer (CMO) will collaborate strategically with senior executives to develop and advance clinical development strategies, driving the vision for clinical research and regulatory pathways. The CMO will oversee the successful clinical development of the organization's pipeline programs and serve as the external representative for clinical research and development efforts, engaging with principal investigators, key opinion leaders, and potential industry partners. This role includes representation with regulatory agencies and interactions with the investment community. The CMO will lead the creation of clinical strategies and programs, establishing standards and policies to optimize the success of compounds in development. Key responsibilities encompass developing target product profiles and development plans, executing clinical trials, coordinating with research organizations and vendors, managing clinical advisory boards, enhancing internal clinical research capabilities, and overseeing collaborations with partners and key opinion leaders.

Key Responsibilities :

• Provide insights and guidance for clinical and medical needs to align with strategic direction and new business opportunities across various interests.
• Oversee clinical operations, clinical science, medical monitoring, and regulatory affairs to meet development goals.
• Drive execution of clinical trial plans to generate compelling safety, pharmacokinetic, and efficacy data for regulatory and marketing purposes.
• Prioritize target markets and indications for development.
• Research and identify new therapeutic opportunities that align with the organization's mission and goals.
• Establish and maintain relationships with principal investigators and consultants to understand clinician needs and medical practice patterns.
• Represent and manage clinical and regulatory programs to diverse stakeholders, including regulatory agencies and corporate partners.
• Liaise with other organizations to identify and implement collaborative studies and regulatory activities.
• Participate in safety monitoring and review study publications for scientific content.
• Guide opportunities for joint publications and presentations of scientific and medical data with partners.
• Attract and retain a skilled clinical development team.
• Stay informed about competitors and developments in relevant therapeutic areas by attending scientific meetings and reviewing literature.
• Assist in seeking alliances with pharmaceutical partners to expedite development efforts.
• Maintain collaborations with partners in academia, government, and industry.

Qualifications :

• Board Certified MD/PhD or MD with experience in medical research and drug development.
• 10+ years of relevant experience in the pharmaceutical or biotechnology industries, with a preference for oncology expertise.
• Expertise in medical literature related to oncology and a strong understanding of market needs.
• Experience in global clinical development of small molecules, particularly in Phase 1 to Phase 3 studies.
• Proven track record of leading clinical programs to successful regulatory filings and approvals.
• Comprehensive knowledge of medical, scientific, regulatory, and technical aspects of clinical development.
• Experience leading interactions with regulatory agencies, with knowledge of GCP requirements.
• Credibility within the medical and scientific community, with strong professional relationships in the oncology field.
• Excellent interpersonal and communication skills for engaging with various stakeholders, including senior management and boards.
• Experience presenting to diverse audiences, including teams, boards, and scientific communities.
• Strong management skills with a reputation for fostering success in others.

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