Blue Earth Diagnostics, Inc. (U.S.)
Medical Director, Clinical Development
Blue Earth Diagnostics, Inc. (U.S.), Needham Heights, Massachusetts, us, 02494
Overview
Reporting to the CMO, the Medical Director – Clinical Development will provide medical expertise and strategic leadership to product development programs across the Bracco Molecular Imaging platform. Responsibilities will include providing medical and scientific leadership and input to product development strategies, product profile development, competitive positioning, and pipeline asset lifecycle. With relevant program/project teams, the Medical Director will realize strategic goals by developing and executing Blue Earth sponsored clinical trials across multiple jurisdictions to GCP standards, engaging with thought leaders and stakeholders, contribution to upholding and improvement of policies and processes and supporting cross-functional teams as required. You will collaborate with cross functional teams including medical affairs, regulatory, imaging, pharmacovigilance, non-clinical, clinical operations, biostatistics, editorial and commercial to achieve company goals. This position will operate on a hybrid work schedule, with the expectation of working onsite 3 days a week in our office located at 197 First Avenue, Needham, MA. Responsibilities
Provide medical leadership within cross-functional Programme Management Teams and projects related to clinical development. Provide medical expertise to BED/Bracco MI clinical development programs and strategy including Phase I to successful product approval, and lifecycle management. Activities include: Developing the product development strategy for pipeline assets with cross-functional partners Serving as the primary medical representative in regulatory interactions related to product development Developing clinical protocols, case report forms and clinical study reports for company sponsored programs, as well as medical review of other study-related documents (e.g. imaging charter, statistical analysis plan). Acting as medical monitor for company sponsored clinical studies where appropriate. Supporting the identification and recruitment of potential investigators for participation in Phase I-IV trials, and management of investigator relationships Tracking medical safety for clinical trials and providing medical support for pharmacovigilance activities, including individual case report assessment. Input and review of product investigator brochures and aggregate reports (e.g. development safety update reports) Verifying scientific accuracy of safety and efficacy summaries for regulatory/commercial purposes and assisting with the clinical sections of regulatory dossiers Medical and scientific oversight for Advisory Boards and Conference participation supporting clinical development activities. Providing key medical input into publications and acting as a company medical voice within publication steering committees and managing author relationships Providing strategic input and medical leadership in developing business cases for lifecycle opportunities with cross-functional partners within product development teams, especially medical affairs and commercial Communicating medical and product development strategy with key internal and external stakeholders. Responsibility for planned project activities, agreed upon and executed according to the milestones and the overall clinical development plan (including pre- and post-marketing activities) Interpreting clinical study data and clearly communicating results to internal and external stakeholders Medical input and direction to development of image acquisition and interpretation materials for pipeline assets. Work collaboratively with the New Assets Evaluation team in co-development of clinical development plans for potential new assets, as required. Work collaboratively with the Investigator Initiated Trials (IIT) team to define the IIT strategy and review proposals for pipeline assets Contribute to appropriate SOP and policy development related to product development Perform other duties and activities as assigned, including line management and acting as an internal imaging SME to provide ad-hoc support to medical affairs/commercial teams, in accordance with the needs of the business. Other duties as determined by business needs Education/Qualifications
Medical Degree required Professional Experience, Knowledge, & Technical Skills
Clinical care and research experience in the therapeutic areas in which BED has products/developmental assets, preferred. Minimum of five (5) years post Medical Degree experience, preferably with training and/or work experience in radiology or nuclear medicine, of which at least: Three (3) years are within the Pharmaceutical or Biotech Industry working in Clinical Development Understanding of the clinical trials and FDA approval processes, preferably with experience of FDA interactions. Experience in Real World Evidence / Observational research preferred Knowledge and understanding of US regulatory rules landscape (pertinent FDA Guidance for Industry). Strong business and product marketing acumen, vision and perspective. An ability to lead teams with or without management authority, empowering others while ensuring the quality of deliverables. Ability to comprehend and combine complex sets of data, spanning multiple projects and products/agents. Ability to handle multiple demands in a fast-paced environment and to interact within the context of multidisciplinary teams. Ability to work independently to manage the activities of the function and to be accountable for these activities. Able to effectively plan in the medium to long term. Able to proactively identify issues and problems, describe and assess risk and chances of product development success, and offer solutions and recommendations on product development issues. Able to make decisions under conditions of uncertainty. If required, able to manage, develop and recruit high quality personnel to form, develop and maintain highly effective teams. Ability to travel, domestic and international, estimated at approximately 30%, via airplane, train and/or motor vehicle will be required. Qualified candidate must be legally authorized to be employed in the United States. Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. We also offer a comprehensive benefits package including a complete healthcare plan, 401k with matching, generous paid holidays, and promote work/life harmony. Blue Earth Diagnostics is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law.
#J-18808-Ljbffr
Reporting to the CMO, the Medical Director – Clinical Development will provide medical expertise and strategic leadership to product development programs across the Bracco Molecular Imaging platform. Responsibilities will include providing medical and scientific leadership and input to product development strategies, product profile development, competitive positioning, and pipeline asset lifecycle. With relevant program/project teams, the Medical Director will realize strategic goals by developing and executing Blue Earth sponsored clinical trials across multiple jurisdictions to GCP standards, engaging with thought leaders and stakeholders, contribution to upholding and improvement of policies and processes and supporting cross-functional teams as required. You will collaborate with cross functional teams including medical affairs, regulatory, imaging, pharmacovigilance, non-clinical, clinical operations, biostatistics, editorial and commercial to achieve company goals. This position will operate on a hybrid work schedule, with the expectation of working onsite 3 days a week in our office located at 197 First Avenue, Needham, MA. Responsibilities
Provide medical leadership within cross-functional Programme Management Teams and projects related to clinical development. Provide medical expertise to BED/Bracco MI clinical development programs and strategy including Phase I to successful product approval, and lifecycle management. Activities include: Developing the product development strategy for pipeline assets with cross-functional partners Serving as the primary medical representative in regulatory interactions related to product development Developing clinical protocols, case report forms and clinical study reports for company sponsored programs, as well as medical review of other study-related documents (e.g. imaging charter, statistical analysis plan). Acting as medical monitor for company sponsored clinical studies where appropriate. Supporting the identification and recruitment of potential investigators for participation in Phase I-IV trials, and management of investigator relationships Tracking medical safety for clinical trials and providing medical support for pharmacovigilance activities, including individual case report assessment. Input and review of product investigator brochures and aggregate reports (e.g. development safety update reports) Verifying scientific accuracy of safety and efficacy summaries for regulatory/commercial purposes and assisting with the clinical sections of regulatory dossiers Medical and scientific oversight for Advisory Boards and Conference participation supporting clinical development activities. Providing key medical input into publications and acting as a company medical voice within publication steering committees and managing author relationships Providing strategic input and medical leadership in developing business cases for lifecycle opportunities with cross-functional partners within product development teams, especially medical affairs and commercial Communicating medical and product development strategy with key internal and external stakeholders. Responsibility for planned project activities, agreed upon and executed according to the milestones and the overall clinical development plan (including pre- and post-marketing activities) Interpreting clinical study data and clearly communicating results to internal and external stakeholders Medical input and direction to development of image acquisition and interpretation materials for pipeline assets. Work collaboratively with the New Assets Evaluation team in co-development of clinical development plans for potential new assets, as required. Work collaboratively with the Investigator Initiated Trials (IIT) team to define the IIT strategy and review proposals for pipeline assets Contribute to appropriate SOP and policy development related to product development Perform other duties and activities as assigned, including line management and acting as an internal imaging SME to provide ad-hoc support to medical affairs/commercial teams, in accordance with the needs of the business. Other duties as determined by business needs Education/Qualifications
Medical Degree required Professional Experience, Knowledge, & Technical Skills
Clinical care and research experience in the therapeutic areas in which BED has products/developmental assets, preferred. Minimum of five (5) years post Medical Degree experience, preferably with training and/or work experience in radiology or nuclear medicine, of which at least: Three (3) years are within the Pharmaceutical or Biotech Industry working in Clinical Development Understanding of the clinical trials and FDA approval processes, preferably with experience of FDA interactions. Experience in Real World Evidence / Observational research preferred Knowledge and understanding of US regulatory rules landscape (pertinent FDA Guidance for Industry). Strong business and product marketing acumen, vision and perspective. An ability to lead teams with or without management authority, empowering others while ensuring the quality of deliverables. Ability to comprehend and combine complex sets of data, spanning multiple projects and products/agents. Ability to handle multiple demands in a fast-paced environment and to interact within the context of multidisciplinary teams. Ability to work independently to manage the activities of the function and to be accountable for these activities. Able to effectively plan in the medium to long term. Able to proactively identify issues and problems, describe and assess risk and chances of product development success, and offer solutions and recommendations on product development issues. Able to make decisions under conditions of uncertainty. If required, able to manage, develop and recruit high quality personnel to form, develop and maintain highly effective teams. Ability to travel, domestic and international, estimated at approximately 30%, via airplane, train and/or motor vehicle will be required. Qualified candidate must be legally authorized to be employed in the United States. Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. We also offer a comprehensive benefits package including a complete healthcare plan, 401k with matching, generous paid holidays, and promote work/life harmony. Blue Earth Diagnostics is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law.
#J-18808-Ljbffr