Director, Medical Information

ELKA Search Partners; Philadelphia (Philadelphia County); On-site; USD 170,000 - 230,000; Full time

Job summary

ELKA Search Partners is seeking an experienced Director, Medical Information to lead the Medical Information function for a growing clinical-stage biotechnology company in the greater Philadelphia area. The role requires four days per week on-site and coordination across Medical Affairs, Commercial, Regulatory, Legal, Pharmacovigilance, Clinical Development and Quality.

The ideal candidate will oversee external partners, ensure timely, accurate and compliant scientific information, and drive

Qualifications

• 8+ years of pharmaceutical or biotechnology industry experience, including significant Medical Affairs/Medical Information experience.
• Experience developing Medical Information response documents and managing complex inquiries.
• Experience reviewing promotional and scientific materials with compliance knowledge.
• Strong scientific judgment and ability to translate clinical information into clear responses.

Responsibilities

• Lead the Medical Information function and oversee outsourced call center vendors.
• Develop and maintain Medical Information processes, SOPs, and governance documents.
• Draft and approve standard response letters and scientifically accurate materials.
• Manage complex inquiry escalations and route adverse events and other reportable information appropriately.
• Serve as Medical reviewer for promotional/scientific materials in collaboration with multiple functions.

Skills

Medical Information

Pharma/Biotech experience

Regulatory compliance

Scientific communication

Education

PharmD/PhD/MD or equivalent

Job description

We are seeking an experienced Director, Medical Information to lead the Medical Information function for a growing clinical-stage biotechnology company approaching an important period of regulatory and commercial development. This is a highly visible, hands-on role with responsibility for overseeing external partners and ensuring healthcare professionals, patients, caregivers and other stakeholders receive timely, accurate and compliant scientific information.

The ideal candidate will be comfortable working in a lean biotech environment where leaders are expected to think strategically while remaining close to execution. This individual will partner across Medical Affairs, Commercial, Regulatory, Legal, Pharmacovigilance, Clinical Development and Quality.

This position is based in the greater Philadelphia area and requires four days per week on-site.

Key Responsibilities:

• Lead the Medical Information function and oversee the company’s third-party Medical Information call center, including vendor performance, quality, compliance and service levels
• Develop and maintain Medical Information processes, training, quality standards, performance metrics, SOPs and governance documents
• Review, approve and draft Standard Response Letters and other scientifically accurate, balanced, appropriately referenced and compliant response materials
• Manage complex inquiry escalations, monitor inquiry trends and ensure adverse events, product complaints and other reportable information are routed appropriately
• Serve as a Medical reviewer for promotional and scientific materials, partnering closely with Medical Affairs, Commercial, Regulatory, Legal, Pharmacovigilance, Clinical Development and Quality

Qualifications:

• 8+ years of pharmaceutical or biotechnology industry experience, including significant experience in Medical Affairs and/or Medical Information
• Demonstrated experience developing Medical Information response documents, managing complex inquiries and overseeing outsourced vendors or call centers
• Experience reviewing promotional and scientific materials, with a strong understanding of pharmaceutical compliance requirements and scientific exchange principles
• Strong scientific judgment and communication skills, with the ability to translate complex clinical information into clear, accurate and practical responses
• PharmD, Ph.D., MD or another relevant advanced degree preferred, with experience in a small biotech environment and supporting product launches strongly preferred