[Voronoi, Inc.] Contract Medical Director (Remote work available)
경력사항
경력 5년 이상근무지
One Broadway, 1 Broadway, Cambridge, MA 02142, USAOne Broadway, 1 Broadway, Cambridge, MA 02142, USA
Voronoi is seeking a dynamic Medical Director who thrives in a fast-paced environment to partner cross functionally with drug discovery, translational medicine, clinical operations, clinical investigators and disease-specific experts, to oversee the design and conduct of clinical trials, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
Responsibilities:
- Author protocols and contributes to authoring of clinical study reports, IBs, IND summary documents, CTAs, ICFs, training documents, and other clinical and regulatory documents.
- Perform medical and related safety/efficacy data reviews with minimal oversight. may be responsible for analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Prepare and communicate a clear overview of trial results for internal presentations, external scientific publications and regulatory purposes.
- Manage drug safety and pharmacovigilance activities for trials
- Attend and support clinical site initiation visits
- Rapidly integrate new insights derived from trials, translational science or basic science into Voronoi's development plans and clinical trial activities
- Collaborate with research leadership and drug discovery teams to shape Voronoi's drug discovery portfolio
- Provide organizational support for data monitoring review, prepare updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
- Proactively manage communication and build strong collaborative relationships with key internal and external stakeholders (study sites, vendors, committees, etc.) in support of program-level development strategy as well as clinical trial objectives; respond to or triage questions for appropriate escalations.
- Ensure Voronoi maintains the highest standards of compliance and ethical behavior in the design, conduct, interpretation and communication of clinical trials, clinical trial data, and clinical trial results.
- Conduct literature reviews as needed
Background and Requirements:
- MD, MD/PhD or other advanced degree with 5+ years of clinical development experience in industry settings. Experience with global early stage oncology trials is required.
- A minimum of 3 years of clinical experience in oncology within the biotechnology or pharmaceutical industry.
- Experience with the design and execution of clinical trials; protocol development and design, development of case report forms, and statistical analysis plans
- Prior experience working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials
- Excellent written and oral communication skills
- Ability to work flexible hours. Internal team and study sites are spread across EU and Asia
- Travel required as per project demands
- Previous experience with pharmacovigilance and statistical principles desirable
공유하기
[Voronoi, Inc.] Contract Medical Director (Remote work available)
Voronoi is seeking a dynamic Medical Director who thrives in a fast-paced environment to partner cross functionally with drug discovery, translational medicine, clinical operations, clinical investigators and disease-specific experts, to oversee the design and conduct of clinical trials, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
Responsibilities:
- Author protocols and contributes to authoring of clinical study reports, IBs, IND summary documents, CTAs, ICFs, training documents, and other clinical and regulatory documents.
- Perform medical and related safety/efficacy data reviews with minimal oversight. may be responsible for analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Prepare and communicate a clear overview of trial results for internal presentations, external scientific publications and regulatory purposes.
- Manage drug safety and pharmacovigilance activities for trials
- Attend and support clinical site initiation visits
- Rapidly integrate new insights derived from trials, translational science or basic science into Voronoi's development plans and clinical trial activities
- Collaborate with research leadership and drug discovery teams to shape Voronoi's drug discovery portfolio
- Provide organizational support for data monitoring review, prepare updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
- Proactively manage communication and build strong collaborative relationships with key internal and external stakeholders (study sites, vendors, committees, etc.) in support of program-level development strategy as well as clinical trial objectives; respond to or triage questions for appropriate escalations.
- Ensure Voronoi maintains the highest standards of compliance and ethical behavior in the design, conduct, interpretation and communication of clinical trials, clinical trial data, and clinical trial results.
- Conduct literature reviews as needed
Background and Requirements:
- MD, MD/PhD or other advanced degree with 5+ years of clinical development experience in industry settings. Experience with global early stage oncology trials is required.
- A minimum of 3 years of clinical experience in oncology within the biotechnology or pharmaceutical industry.
- Experience with the design and execution of clinical trials; protocol development and design, development of case report forms, and statistical analysis plans
- Prior experience working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials
- Excellent written and oral communication skills
- Ability to work flexible hours. Internal team and study sites are spread across EU and Asia
- Travel required as per project demands
- Previous experience with pharmacovigilance and statistical principles desirable