Senior Director, Medical Affairs
Behavioral Health Market Context
Apply Nowvia Marit Health
Job Description
metry panel and LDTs, alongside a deep understanding of laboratory operations, hematology, hematology-oncology, and relevant guidelines and regulations.
Practice Info
• Oversight of internal medical laboratory and other medical affairs teams
• Focus on Biosciences Clinical portfolio of products
• Collaboration with internal and external stakeholders
• Collaboration with Clinical Development and Operations teams and Field Facing Medical Affairs functions
• Collaboration with Clinical Platforms Program Management
• Preferred location in Milpitas, with remote candidates considered with regular travel to company location
Responsibilities
• Provide leadership for overall Medical Affairs and Clinical Affairs teams
• Provide leadership for clinical projects in collaboration with both internal and external stakeholders to further Biosciences business goals and objectives
• Develop and manage the team of laboratory professionals who work in the Biosciences Medical Laboratory, to ensure timely and productive services as requested or required
• Develop and manage Medical Affairs team to ensure effective and compliant clinical products, performance evaluation studies, and clinical trials to support regulatory and commercial goals
• Develop and manage the Clinical Affairs team in support of clinical site selection, study design and execution of clinical trials and analytical validation studies to support regulatory and commercial goals
• Oversee internal medical input into verification and validation studies for clinical products
• Develop strategic relationships with key customers to advance supporting evidence generation of Biosciences products
• Ownership of on-time quality assessments, medical device reporting and health risk assessments to the FDA and other regulatory bodies
Shift & Schedule
• Travel up to 30% as needed to support organizational goals
Requirements
• Minimum 10-15 years of experience in a regulated diagnostic healthcare environment
• Prior experience in clinical trial design, operations, and execution
• Prior experience in clinical site engagement and clinical sample acquisition
• Deep understanding of regulations pertaining to S. LDT and IVD development
• Deep understanding of CLSI guidelines
• Experience managing clinical flow cytometry laboratory operations and laboratory personnel
• Experience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites
• Experience managing all functions related to clinical study design and execution: CSMs, CRAs, etc.
• Requires an MD or MD/PhD, with specialization in Laboratory Medicine
• Board certification in Hematopathology, with extensive experience and a record of scientific achievements in flow cytometry, cell sorting, and molecular biology is preferred
Practice Info
• Oversight of internal medical laboratory and other medical affairs teams
• Focus on Biosciences Clinical portfolio of products
• Collaboration with internal and external stakeholders
• Collaboration with Clinical Development and Operations teams and Field Facing Medical Affairs functions
• Collaboration with Clinical Platforms Program Management
• Preferred location in Milpitas, with remote candidates considered with regular travel to company location
Responsibilities
• Provide leadership for overall Medical Affairs and Clinical Affairs teams
• Provide leadership for clinical projects in collaboration with both internal and external stakeholders to further Biosciences business goals and objectives
• Develop and manage the team of laboratory professionals who work in the Biosciences Medical Laboratory, to ensure timely and productive services as requested or required
• Develop and manage Medical Affairs team to ensure effective and compliant clinical products, performance evaluation studies, and clinical trials to support regulatory and commercial goals
• Develop and manage the Clinical Affairs team in support of clinical site selection, study design and execution of clinical trials and analytical validation studies to support regulatory and commercial goals
• Oversee internal medical input into verification and validation studies for clinical products
• Develop strategic relationships with key customers to advance supporting evidence generation of Biosciences products
• Ownership of on-time quality assessments, medical device reporting and health risk assessments to the FDA and other regulatory bodies
Shift & Schedule
• Travel up to 30% as needed to support organizational goals
Requirements
• Minimum 10-15 years of experience in a regulated diagnostic healthcare environment
• Prior experience in clinical trial design, operations, and execution
• Prior experience in clinical site engagement and clinical sample acquisition
• Deep understanding of regulations pertaining to S. LDT and IVD development
• Deep understanding of CLSI guidelines
• Experience managing clinical flow cytometry laboratory operations and laboratory personnel
• Experience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites
• Experience managing all functions related to clinical study design and execution: CSMs, CRAs, etc.
• Requires an MD or MD/PhD, with specialization in Laboratory Medicine
• Board certification in Hematopathology, with extensive experience and a record of scientific achievements in flow cytometry, cell sorting, and molecular biology is preferred
Qualifications
- •Minimum 10-15 years of experience in a regulated diagnostic healthcare environment
- •Prior experience in clinical trial design, operations, and execution
- •Prior experience in clinical site engagement and clinical sample acquisition
- •Deep understanding of regulations pertaining to S
- •LDT and IVD development
- •Deep understanding of CLSI guidelines
- •Experience managing clinical flow cytometry laboratory operations and laboratory personnel
- •Experience managing all functions related to clinical study design and execution: CSMs, CRAs, etc
- •Requires an MD or MD/PhD, with specialization in Laboratory Medicine
Benefits
Responsibilities
- •This pivotal role involves contributing to strategy, evidence generation, and post-market medical surveillance for the Biosciences Clinical portfolio
- •The successful candidate will possess technical expertise in flow cytometry panel and LDTs, alongside a deep understanding of laboratory operations, hematology, hematology-oncology, and relevant guidelines and regulations
- •Oversight of internal medical laboratory and other medical affairs teams
- •Focus on Biosciences Clinical portfolio of products
- •Collaboration with internal and external stakeholders
- •Collaboration with Clinical Development and Operations teams and Field Facing Medical Affairs functions
- •Collaboration with Clinical Platforms Program Management
- •Preferred location in Milpitas, with remote candidates considered with regular travel to company location
- •Provide leadership for overall Medical Affairs and Clinical Affairs teams
- •Provide leadership for clinical projects in collaboration with both internal and external stakeholders to further Biosciences business goals and objectives
- •Develop and manage the team of laboratory professionals who work in the Biosciences Medical Laboratory, to ensure timely and productive services as requested or required
- •Develop and manage Medical Affairs team to ensure effective and compliant clinical products, performance evaluation studies, and clinical trials to support regulatory and commercial goals
- •Develop and manage the Clinical Affairs team in support of clinical site selection, study design and execution of clinical trials and analytical validation studies to support regulatory and commercial goals
- •Oversee internal medical input into verification and validation studies for clinical products
- •Develop strategic relationships with key customers to advance supporting evidence generation of Biosciences products
- •Ownership of on-time quality assessments, medical device reporting and health risk assessments to the FDA and other regulatory bodies
- •Shift & Schedule
- •Travel up to 30% as needed to support organizational goals
- •Experience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites
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