The Associate Director, Medical Monitor, plays a critical role in the Clinical Development team, collaborating with cross-functional teams such as the Pharmacovigilance and Regulatory teams to make informed decisions. This role specializes in providing medical expertise and clinical support throughout clinical development, including but not limited to medical/clinical authorship and maintenance of clinical study protocols, informed consent forms and other protocol-related documents, clinical development plans, investigator’s brochures, and clinical study reports. The Medical Monitor will be the Sponsor’s primary medical and scientific point of contact for CROs and investigational sites for Melinta-sponsored studies.

Responsibilities:

• Provide clinical leadership and medical strategic input for deliverables for the company. Deliverables may include clinical development plans, data review, program specific standards, clinical components of regulatory documents, and publications (e.g., investigator’s brochures, briefing books, safety updates, submission dossiers, and responses to health authorities)
• Support the Head of Development by providing medical input and clinical trial reviews and contributing/driving development of clinical standards
• Ensures the medical and scientific quality of clinical trial protocols, case report forms, and clinical trial reports
• Interact with staff across functional areas to ensure highest level of client satisfaction through execution of successful projects
• Maintain working knowledge of Good Clinical Practice and regulatory requirements relating to clinical development and safety compliance with ethical, legal, and regulatory standards
• Occasionally participate in proposal generation, feasibility assessments, and review of proposal/contracts for medical services

Qualifications:

• Medical Doctor (MD) or equivalent medical degree
• 2 to 5 years of experience in clinical development and medical monitoring in a pharmaceutical or biotech setting
• In-depth knowledge of Good Clinical Practice (GCP) and regulatory requirements
• Strong analytical and critical thinking skills
• Excellent communication and interpersonal skills
• Ability to work effectively in a collaborative, cross-functional team environment
• Familiarity with relevant therapeutic areas and the ability to stay abreast of current medical and scientific developments

Position Type

Location / Travel

New Jersey home office preferred