Description

This person will independently lead, direct and coordinate team activities (development and/or clinical) to ensure completion of the clinical development of projects. Knowledge in a broad area of science/technology, and CNS applications is essential. The successful candidate will be a member of the executive management team to ensure clinical projects are adequately resourced to meet development project milestones. He/She will determine and pursue courses of action necessary to meet the goals and objectives for the company. He/She will be the primary contact for Clinical related questions, the FDA and other regulatory agencies.

Responsibilities

• Provide leadership, direction and medical expertise to the clinical department as a corporate officer.
• Evaluate safety and efficacy data.
• Be the primary contact with the FDA, clinical investigators and the clinical advisory board.
• Effectively utilize outsourcing, as appropriate, to achieve project goals in a timely manner.
• Develop detailed clinical development plans and clinical protocols acceptable to global regulatory authorities; apply principles of drug development science and regulatory science to build thorough but compact clinical development plans.
• Responsible for recruiting key opinion leaders.
• Responsible for developing patterning strategy and conducting due diligence.
• Presenting to potential business partners.
• Responsible for writing the clinical sections of IND and NDA.

Requirements

• An M.D. or M.D./Ph.D., preferably with board certification in Neurology or other relevant specialty.
• 8-10 or more years of industry clinical trials/drug development experience.
• Ability to work in a team environment.
• Must have enthusiasm for formulating and executing clinical development plans.
• VP/CMO will have the skills and perspective of clinical development with sufficient experience to take charge and complete all necessary development steps for drug approval.
• Experience with both US and ex-US regulatory filings.
• Experience with multiple regulatory disciplines (CMC, clinical, labeling, etc.).
• Deep and broad knowledge of worldwide compliance requirements; direct experience with pharmaceutical development and commercial processes worldwide.
• Proven track record of effective collaboration with regulatory agencies (FDA and DEA).
• Minimum of 5-7 years of supervisory experience with strong problem-solving skills.
• Must be willing to travel as needed. Proficient oral/written communication skills are essential.
• Strong work ethic and personal desire for success.
• A proven track record working with key opinion leaders and SAB.
• Proven track record in conducting Phase I-III clinical trials.
• Proven track record in filing an IND and NDA.

To apply for this position at Neuraltus, please send a cover letter and CV to hr@neuraltus.com.