Medical Director

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job Summary:

The Medical Director position is responsible for medical monitoring, medical input for RFI and RFP development, and other study related medical services as requested.

Essential Functions:

• Oversees the management of medical monitoring during clinical trials and projects, including development of Medical Monitoring Plan.
• Acts as liaison for investigators and monitors regarding study-related medical/safety issues and resolution of study protocol and patient eligibility issues, per contract deliverables.
• Provides and/or oversees medical review of key clinical documents, Individual Case Safety Reports, and medical or safety-related regulatory documents.
• Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
• May present topline results to Sponsors or Competent Authorities.
• Trains project team on therapeutic indication and/or treatment modality.
• Oversees, reviews, and directs medical and safety sections of regulatory document submissions.
• Assists with RFI/RFP completion and contributes medical/scientific expertise to proposal development.
• Actively participates in early client engagement calls, representing the medical/scientific function and supporting business development discussions.
• Partners with internal teams to develop strategic input for proposals and study design, ensuring alignment with client objectives and scientific rigor.
• Attends and supports sales capabilities meetings, providing subject matter expertise to showcase organizational strengths.
• Other duties as assigned

Necessary Skills and Abilities:

• Excellent organizational skills.
• Strong written communication skills.
• Ability to prioritize workload and meet deadlines.
• Flexible and proactive toward changing needs.
• Effective interpersonal communication skills.
• Must have the ability to understand and analyze complex clinical and statistical data

Educational Requirements:

• Medical Degree (MD/DO) or international equivalent from an accredited university.
• Completion of an accredited residency program.
• Certification: Preferably board certified in the US.

Experience Requirements:

• Minimum of one (1) year in a CRO environment.
• Minimum of three (3) years of clinical research and medical/safety management experience in the pharmaceutical industry;
• Minimum of five (5) years of clinical, patient-facing experience, post-residency.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***