VP, Clinical Development (Infectious Disease)
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Описание вакансии
TL;DR
VP, Clinical Development (Infectious Disease): Leading clinical development strategies for vaccines and prophylactic antibodies with an accent on regulatory excellence and clinical trial design. Focus on driving pipeline programs through Phase I-IV trials, managing cross-functional teams, and ensuring compliance with global regulatory standards.
Location: Must be based in Frederick, Maryland or Berkeley Heights, New Jersey
Salary: $250,000 - $350,000 USD
Company
is a commercial-stage biotechnology company focused on developing treatments for CNS and immunology conditions, including infectious diseases and rare disorders.
What you will do
- Define and lead clinical development strategies for vaccines and prophylactic antibodies.
- Oversee the design, execution, and completion of clinical trials (Phases I-IV).
- Manage CROs, academic partnerships, and external collaborations to optimize trial execution.
- Lead interactions with global regulatory agencies including FDA and EMA.
- Provide medical and scientific leadership to cross-functional teams and mentor staff.
- Represent the company at scientific conferences and investor presentations.
Requirements
- MD or DO degree required.
- 10-15 years of relevant experience in clinical development within pharma or biotech.
- Must have prior experience at the Senior Director level or above.
- Extensive experience with regulatory interactions, submissions (IND, NDA, BLA, CTA), and product approvals.
- Expertise in infectious diseases; experience with Lyme disease or live viral vaccines is a major plus.
- Must be authorized to work in the U.S. as no sponsorship is provided.
Nice to have
- Board certification in Infectious Disease.
- Prior work with prophylactic monoclonal antibodies.
Culture & Benefits
- Comprehensive medical, dental, and vision insurance.
- 401k retirement savings plan with company match.
- Annual discretionary stock options.
- Generous paid time off, sick time, and paid holidays.
- Career development and training opportunities.
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