Chief Medical Officer

Clinical Dynamix, Inc.; Jersey City (NJ); On-site; USD 300,000 - 600,000; Full time

Job summary

Clinical Dynamix, Inc. seeks a Chief Medical Officer to partner with the CEO and guide the company’s drug development from preclinical to regulatory milestones, prioritizing programs and accelerating candidates.

The CMO will represent the company to regulators and investors and build a high-performing clinical team. The role requires extensive senior-level experience in clinical development, leadership and a strong track record with nephrology-focused programs, IND/NDA submissions, and global

Qualifications

• Senior-level experience in clinical development in pharma/biotech.
• Thorough understanding of drug development and registration processes.
• MD or MD/PhD in Nephrology/Internal Medicine required.

Responsibilities

• Provide leadership and clinical perspective to research, development, quality and regulatory strategies.
• Manage overall clinical development for lead programs from early development to pivotal studies and regulatory submissions.
• Ensure Company meets its clinical and regulatory milestones.
• Represent Company at FDA, EMEA and other regulatory agencies.
• Maintain understanding of competitors and developments by attending meetings and tracking literature.
• Represent and manage clinical and regulatory programs to diverse audiences including FDA, shareholders, partners and Board members.
• Lead interactions with the scientific and business communities at conferences and collaborations.
• Establish and foster relationships with key opinion leaders and international medical community.
• Assist in seeking product and technology alliances to accelerate development of assets.
• Establish collaborations with partners in academia, government and industry.

Skills

Leadership

Regulatory experience

Clinical development

Communication

Stakeholder management

FDA/EMA interactions

Education

MD or MD/PhD (Nephrology/Internal Medicine)

Job description

Chief Medical Officer

POSITION SUMMARY

The Chief Medical Officer is a strategic partner to the Chief Executive Officer, helps build, develop, lead and drive the Company’s preclinical through clinical pipeline. This leader is responsible for the company’s drug development portfolio including responsibility for prioritizing and accelerating the development of Company’s drug candidates. The CMO serves as the key member of the Executive Team and actively participates in strategic planning, partnering discussions and presentations to the Board of Directors and investors.

Key Responsibilities

• Provide leadership and clinical perspective to the research, development, quality and comprehensive regulatory strategies.


• Manage the overall clinical development for lead programs including early development, clinical proof of concept, pivotal studies and regulatory submissions.


• Ensure Company meets its clinical and regulatory milestones.


• Represent Company at the highest level at the FDA, EMEA and other regulatory agencies.


• Maintain understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and tracking literature.


• Represent and manage the company’s clinical and regulatory programs to diverse audiences including: FDA, shareholders, corporate partners, Board of Directors and other key stakeholders.


• Represent Company both internally and externally vis‑a‑vis the scientific and business communities including scientific conferences, presentations, industry and Wall Street.


• Build and maintain solid working relationships with key opinion leaders and lead clinical investigators. Establish and foster relationships with the international scientific and medical community.


• Actively assist in seeking product and/or technology alliances with appropriate pharmaceutical company partners to enhance/expedite the development of the company’s assets.


• Helping to establish and maintain collaborations with partners in academia, government and industry.

PROFESSIONAL Experience/QUALIFICATIONS

The successful candidate must have extensive senior-level experience in clinical development, ideally with both larger pharmaceutical as well as with biotechnology companies. This person will have a thorough understanding of all the requirements and processes needed to take a potential drug through clinical development and ultimately registration.

Key requirements will include:

• An MD or MD/PhD with strong leadership skills and proven biopharmaceutical industry experience in leading clinical development of therapeutic programs, specifically in the Nephrology space is essential.


• Strong leadership skills and proven biopharmaceutical industry experience in leading clinical development from preclinical to phase 3 therapeutic programs. A record of accomplishment including developing, planning, designing and implementing clinical studies in the Nephrology space and experience with the successful registration of therapeutics is highly desirable.


• Experience with IND and NDA submissions including formal interaction with regulatory agencies is essential.


• A thorough understanding of the drug development process.


• Entrepreneurial, resourceful, strategic and energetic leader who is an assertive, driven and hands‑on individual with unquestionable integrity.


• Credibility within the international medical and scientific community. Solid personal and professional relationships with key opinion leaders in the nephrology field is 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 and provide leadership and guidance to a high functioning development team.


• Experience presenting to a wide variety of audiences including internal teams, Board of Directors, investors, medical and scientific communities.


• Highly developed understanding of the external market place to identify long-term benefits for unmet patients’ and customers’ needs.


• Strong management skills and a good reputation for managing others to succeed.

EDUCATION

An MD or MD/PhD is required. (Nephrology / Internal Medicine)