Medical Director

i-Pharm Consulting; New York (NY); On-site; USD 280,000 - 330,000; Full time

Benefits offered by this job

Mentorship from leadership team

Professional development opportunities

Flexible hybrid work arrangement

Impact on life-changing therapies

Job summary

A leading rare disease biotech company in New York is seeking a Senior/Executive Medical Director to lead clinical development efforts. This position focuses on rare disease programs and includes key responsibilities in regulatory submissions and cross-functional collaboration. The role offers a competitive salary range of $280,000 to $330,000 plus a bonus. Candidates with an MD and 3-5 years of industry experience are encouraged to apply.

Qualifications

• 3-5 years in pharmaceutical/biotech industry required.
• Experience with regulatory submissions and FDA interactions needed.
• Demonstrated experience in cross-functional teams.

Responsibilities

• Lead clinical development activities across rare disease programs.
• Write clinical protocols and oversee safety summaries.
• Support FDA meeting preparations and regulatory submissions.
• Collaborate with external vendors and MSLs.

Skills

Clinical development leadership

Regulatory and compliance expertise

Strong protocol writing skills

Cross-functional team collaboration

Ability to manage multiple priorities

Education

MD degree with US residency training

Residency in Internal Medicine or Pediatrics

Job description

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.