Job Description

Job Description

Job Description

Job Title: Chief Medical Officer

Job Description:

The Chief Medical Officer (CMO) will serve as a key member of the executive leadership team, reporting to the CEO and overseeing the company's clinical and product development strategy. The ideal candidate will bring deep expertise in clinical trial design and execution, particularly for orphan diseases; a strong track record of working with regulatory agencies; and experience in cell or gene therapy. The CMO will play a pivotal role in shaping the company's vision, fostering strategic partnerships, and interacting with stakeholders including investors, potential strategic partners, patient advocacy groups, KOLS, and our Board of Directors. Ideally, the candidate will be willing to relocate to the Dallas-Fort Worth area, but exceptional remote candidates will be considered.

Key Responsibilities:

Clinical Strategy and Leadership :

• Develop and oversee the clinical development strategy for our pipeline candidates, ensuring alignment with corporate goals and regulatory requirements.

• Lead clinical trial design, execution, and interpretation.

Regulatory Affairs :

• Lead interactions with the FDA and other global regulatory agencies, including preparation of INDs, briefing packages, and responses to regulatory queries.

• Ensure compliance with all regulatory standards and oversee regulatory submissions.

Clinical Operations Oversight :

• Oversee the execution of clinical trials, ensuring timelines, budgets, and quality standards are met.

• Collaborate with cross-functional teams, including CMC, preclinical development, and others to drive program success.

Product Development :

• Lead the integration of clinical and preclinical insights into the product development pipeline.

• Guide product strategy to ensure seamless transition from development to commercialization.

• Partner with the R&D and manufacturing teams to refine product profiles and achieve regulatory and commercial readiness.

Data Interpretation and Communication :

• Analyze and interpret clinical trial data, ensuring robust and accurate representation of results.

• Represent the company in scientific meetings, investor presentations, and key external forums.

Patient Advocacy and Medical Affairs :

• Build and maintain relationships with key opinion leaders (KOLs), patient advocacy groups, and scientific collaborators.

• Guide medical affairs strategy to support commercialization planning and post-approval activities.

Team Leadership :

• Mentor and lead a high-performing medical, clinical development, and product development team

Qualifications:

Education :

• MD, MD/PhD, or equivalent with a strong clinical research background.

Experience :

• 10+ years in clinical development, with some experience in orphan diseases and/or cell or gene therapies.

• Proven track record of leading successful clinical trials and advancing drug candidates through regulatory milestones.

• Experience interacting with the FDA, EMA, and other global regulatory bodies.

Skills :

• Deep knowledge of clinical trial design, execution, and data interpretation.

• Exceptional leadership and strategic planning abilities.

• Strong communication and interpersonal skills, with the ability to engage diverse stakeholders, including KOLs, regulators, and investors.

Location Requirement :

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