Base pay range
$280,000.00/yr - $380,000.00/yr
Executive Consultant-Clinical Development, Medical Affairs and Commercial
Senior/Executive Medical Director - Clinical Development
Company: a leading rare disease biotech company
Location: New York, US (Hybrid - Remote with 2-3 days per fortnight/ 3 weeks in office). A substantial amount of the business are based in surrounding areas such as Boston, New Jersey and Pennsylvania
About Our Client
Our client is a well-established clinical-stage biopharmaceutical company with a focused pipeline of novel therapeutics for rare and orphan diseases. The company has multiple programs in late-stage development approaching key regulatory milestones including NDA submissions and confirmatory studies across metabolic and neurological indications.
Position Summary
We are seeking a hands-on Senior / Executive Medical Director to join the Clinical Development team during an exciting period of growth. This role will provide critical support to the Chief Medical Officer across multiple rare disease programs, with immediate focus on lead programs as the company prepares for NDA submissions and potential confirmatory studies.
This role will be an excellent position for a Medical Director who is professionally trained in the following areas:
- Rare disease or orphan drug development
Key Responsibilities
Clinical Development Leadership
- Lead day-to-day clinical development activities across multiple rare disease programs
- Write and review clinical protocols, particularly for Phase 3 studies and open-label extensions
- Oversee safety summaries and investigator brochure updates
- Manage expanded access programs (multiple currently ongoing)
- Design and implement confirmatory studies as required by regulatory agencies
Regulatory & Compliance
- Support FDA meeting preparations and regulatory submissions
- Ensure compliance with regulatory requirements across all clinical programs
- Contribute to NDA submission activities and regulatory strategy
Cross-Functional Collaboration
- Work closely with Clinical Operations, Data Management, and Medical Affairs teams
- Collaborate with MSLs on scientific publications and congress presentations
- Interface with external vendors including CROs and statistical consultants
- Support medical monitoring activities as needed
Strategic Contribution
- Participate in clinical development strategy discussions
- Provide medical expertise to support business development activities
- Contribute to investor presentations and scientific communications
Required Qualifications
Education & Training
- MD degree with completion of US residency training
- Residency in Internal Medicine, Pediatrics, or relevant medical subspecialty
- Previous academic medicine experience preferred
Industry Experience
- 3-5 years of pharmaceutical/biotechnology industry experience
- Experience with regulatory submissions and FDA interactions
- Demonstrated experience in cross-functional team environments
Core Competencies
- Strong protocol writing and clinical development skills
- Regulatory and compliance expertise
- Ability to work independently and manage multiple priorities
- Doer mentality - hands-on approach
- Flexibility to wear multiple hats in a dynamic biotech environment
Whats on offer:
- Competitive base salary: $280,000 - $330,000 and compensation package + bonus
- Professional development: opportunity to work across multiple rare disease programs, experience with NDA submissions and regulatory interactions
- Mentorship from an experienced senior leadership team
- Collaborative, mission-driven team focused on rare diseases
- Flexible hybrid work arrangement
- Direct impact on bringing life-changing therapies to patients
End of refined description.
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