VP, Clinical Development - Infectious Disease
Tonix Pharmaceuticals
19 days ago
Remote friendly (Frederick, MD)
United States
$250,000 - $350,000 USD yearly
Clinical Research and Development
Position: Vice President (VP), Clinical Development - Infectious Disease
Responsibilities:
- Define and lead clinical development strategy for assigned vaccines and prophylactic antibodies.
- Oversee planning, design, execution, and completion of clinical trials (Phases I-IV); develop protocols, investigator brochures, statistical analysis plans, and regulatory documents; ensure data quality with Clinical Operations; support scientific communications/publications.
- Oversee selection and management of CROs, academic partnerships, and external collaborations.
- Drive operational excellence and regulatory compliance across Clinical Development (GCP, quality assurance, ethical considerations, scientific integrity).
- Represent the company at scientific conferences/industry consortia/investor presentations.
- Lead Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
- Provide medical/scientific leadership to cross-functional teams (Medical Affairs, Regulatory Affairs, Commercial).
- Lead global regulatory engagement and submissions (IND, NDA, BLA, CTA) and post-approval commitments.
- Build relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations; build/mentor high-performing teams.
Qualifications:
- MD or DO.
- 10–15 years relevant experience with progressive clinical development leadership (Senior Director level or above).
- Demonstrated success leading clinical development programs.
- Extensive regulatory compliance experience (interactions, submissions, approvals).
- Comprehensive budget management experience.
- Board certification in Infectious Disease (plus).
- Expertise in infectious diseases; prior Lyme disease, live viral vaccines, and/or prophylactic monoclonal antibodies (major plus).
Compensation & Benefits (highlights):
- Salary range: $250,000–$350,000 USD.
- Medical/dental/vision, life/AD&D, disability, FSA/HSA, EAP, pet insurance, 401k match & stock options, paid time off/sick time/holidays, career development.
Application instructions:
- Tonix does not accept agency resumes unless contacted by internal Talent Acquisition; do not forward unsolicited resumes to employees or other locations.
Responsibilities:
- Define and lead clinical development strategy for assigned vaccines and prophylactic antibodies.
- Oversee planning, design, execution, and completion of clinical trials (Phases I-IV); develop protocols, investigator brochures, statistical analysis plans, and regulatory documents; ensure data quality with Clinical Operations; support scientific communications/publications.
- Oversee selection and management of CROs, academic partnerships, and external collaborations.
- Drive operational excellence and regulatory compliance across Clinical Development (GCP, quality assurance, ethical considerations, scientific integrity).
- Represent the company at scientific conferences/industry consortia/investor presentations.
- Lead Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
- Provide medical/scientific leadership to cross-functional teams (Medical Affairs, Regulatory Affairs, Commercial).
- Lead global regulatory engagement and submissions (IND, NDA, BLA, CTA) and post-approval commitments.
- Build relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations; build/mentor high-performing teams.
Qualifications:
- MD or DO.
- 10–15 years relevant experience with progressive clinical development leadership (Senior Director level or above).
- Demonstrated success leading clinical development programs.
- Extensive regulatory compliance experience (interactions, submissions, approvals).
- Comprehensive budget management experience.
- Board certification in Infectious Disease (plus).
- Expertise in infectious diseases; prior Lyme disease, live viral vaccines, and/or prophylactic monoclonal antibodies (major plus).
Compensation & Benefits (highlights):
- Salary range: $250,000–$350,000 USD.
- Medical/dental/vision, life/AD&D, disability, FSA/HSA, EAP, pet insurance, 401k match & stock options, paid time off/sick time/holidays, career development.
Application instructions:
- Tonix does not accept agency resumes unless contacted by internal Talent Acquisition; do not forward unsolicited resumes to employees or other locations.