Medical Director, Clinical Development
184K–245K a year
Behavioral Health Market Context
Apply Nowvia Marit Health
Job Description
or more studies, accountable for study design, execution, monitoring, delivery, and reporting, collaborating with cross-functional teams to ensure scientific rigor and operational excellence.
Practice Info
• Location: Northeast Preferred
Responsibilities
• Lead the conception, study design, study protocols, medical monitoring and medical interpretation of Invivyd's clinical trials in collaboration with other departments (Biometrics, Clinical Operations, Regulatory Affairs and Medical Affairs)
• Provide clinical leadership and medical strategic input for deliverables in the assigned project/program, including sections of individual protocols, data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
• Lead the timely drafting of clinical responses to questions from regulatory authorities
• Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
• Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
• Develop and maintain close professional relationships with key thought leaders and healthcare practitioners within the medical and scientific community
• Provide impactful medical expertise to clinical, commercial, market access and regulatory partners
• Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies
Compensation
• Pay Range: $184,000 - $245,000
• Eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity)
Requirements
• MD required
• Board certification in immunology or infectious diseases strongly preferred
• 7+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in phases I through IV
• Experience with monoclonal antibodies or vaccines strongly preferred
• Medical monitoring experience required
• Hands-on participation in successful regulatory approvals is required
• Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projects
• Ability to motivate, influence and collaborate with others across all levels of the organization
• Ability to engage internal and external experts in constructive scientific dialogue around study design, conduct and data interpretation
• Broad working knowledge of FDA requirements, industry compliance, clinical trial design and strategies
Practice Info
• Location: Northeast Preferred
Responsibilities
• Lead the conception, study design, study protocols, medical monitoring and medical interpretation of Invivyd's clinical trials in collaboration with other departments (Biometrics, Clinical Operations, Regulatory Affairs and Medical Affairs)
• Provide clinical leadership and medical strategic input for deliverables in the assigned project/program, including sections of individual protocols, data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
• Lead the timely drafting of clinical responses to questions from regulatory authorities
• Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
• Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
• Develop and maintain close professional relationships with key thought leaders and healthcare practitioners within the medical and scientific community
• Provide impactful medical expertise to clinical, commercial, market access and regulatory partners
• Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies
Compensation
• Pay Range: $184,000 - $245,000
• Eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity)
Requirements
• MD required
• Board certification in immunology or infectious diseases strongly preferred
• 7+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in phases I through IV
• Experience with monoclonal antibodies or vaccines strongly preferred
• Medical monitoring experience required
• Hands-on participation in successful regulatory approvals is required
• Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projects
• Ability to motivate, influence and collaborate with others across all levels of the organization
• Ability to engage internal and external experts in constructive scientific dialogue around study design, conduct and data interpretation
• Broad working knowledge of FDA requirements, industry compliance, clinical trial design and strategies
Qualifications
- •MD required
- •7+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in phases I through IV
- •Medical monitoring experience required
- •Hands-on participation in successful regulatory approvals is required
- •Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projects
- •Ability to motivate, influence and collaborate with others across all levels of the organization
- •Ability to engage internal and external experts in constructive scientific dialogue around study design, conduct and data interpretation
- •Broad working knowledge of FDA requirements, industry compliance, clinical trial design and strategies
Benefits
- •Pay Range: $184,000 - $245,000
- •Eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity)
Responsibilities
- •This strategic leadership role is central to the company's clinical programs, focusing on shaping development strategy, influencing key decisions, and driving the execution of clinical trials
- •The Medical Director will be the medical and scientific authority for one or more studies, accountable for study design, execution, monitoring, delivery, and reporting, collaborating with cross-functional teams to ensure scientific rigor and operational excellence
- •Lead the conception, study design, study protocols, medical monitoring and medical interpretation of Invivyd's clinical trials in collaboration with other departments (Biometrics, Clinical Operations, Regulatory Affairs and Medical Affairs)
- •Provide clinical leadership and medical strategic input for deliverables in the assigned project/program, including sections of individual protocols, data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
- •Lead the timely drafting of clinical responses to questions from regulatory authorities
- •Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
- •Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
- •Develop and maintain close professional relationships with key thought leaders and healthcare practitioners within the medical and scientific community
- •Provide impactful medical expertise to clinical, commercial, market access and regulatory partners
- •Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies
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