Lead Agilist

Position Summary: The Senior Manager, Clinical Research & Programs will lead all Bracco Medical Technologies (BMT) clinical programs, activities, and team members to establish the scientific basis and support for BMT product differentiation. This role will oversee the general clinical research strategy for BMT, as well as develop, plan, and execute product-specific clinical research strategy for BMT. This role will collaborate and partner across functions to identify new opportunities for BMT business through clinical trials, evidence generation, and influencing medical standards of care. This person will contribute to new market expansion by providing clinical assessment of existing and proposed clinical data in support of submissions, contribute significantly to sales and marketing materials intended to educate and inform customers, professionally and credibly represent BMT when presenting to numerous audiences: physicians, clinical staff, clinical and advisory boards and internal teams. Additionally, this role will develop and implement the policies and processes associated with clinical trials, oversee all clinical studies, and manage all scientific communications intended for customers including publications, promotional materials, and training materials. This role will liaise with clinical scientific thought leaders and external researchers for both company-sponsored clinical research and physician-initiated research. Primary Duties & Responsibilities: Clinical Research Identify new indications or new patient populations that could benefit from BMT’s products. Identify the required level of clinical evidence for new projects. Select and manage CROs and clinical contractors as necessary. Contribute to long-term clinical strategies that support business objectives. Develop and implement a PMCF strategy for BMT products. Ensure the Clinical Affairs department operates at a state-of-the-art level in clinical evidence generation. Build and maintain a strong network and close relationships with various internal and external parties. Lead execution for both local and global studies, manages clinical research projects over all the BMT modalities. Provide leadership for the conduct of clinical investigations as it applies to product approval and post-market clinical follow-up activities. Support new product development by creating a clinical plan in conjunction with regulatory and R&D. Oversee the design, plan and development of clinical trials. Oversee the investigator-initiated research program to ensure alignment to the clinical research strategy set in collaboration with Marketing. Develop and monitor financial budget of clinical programs, ensuring appropriate utilization of resources including staff, materials, and equipment. Monitor progress and follow up when issues develop. Work closely with clinical team members and cross-functional teams to ensure that budgets and schedules for deliverables are established and met. Supervise and coordinate the work of the clinical team members. Train, coach and develop team members to ensure consistency of deliverables across team. Work closely with biostatisticians on statistical analysis plans and clinical data analysis. Scientific Evidence Activities Lead the development and execution of the clinical evidence portfolio for multiple programs, ensuring that global market needs are designed into the plan for clinical trial investments (pre-market and post-market). Oversee the strategy, generation, and communication of the product-specific clinical development plans, including pre- and post-market clinical investigations and clinical evaluation reports. Ensure that products have an updated clinical claims matrix. Leadership of product-specific cross-functional clinical evidence collaboration teams to develop, interpret and utilize clinical evidence of products. Clinical lead for creating the clinical claims matrix, working in conjunction with marketing product manager. Responsible for the development of materials including reports, presentations and reviews to support scientific communications. Maintain comprehensive literature database to provide in-depth knowledge and understanding of current clinical practices and research relevant to BMT products. Identify clinical evidence gaps to build into BMT’s clinical research strategy. Maintain and disseminate clinical summary information. Contribute to materials on relevant clinical studies. Collaborate cross-functionally the development and dissemination of new evidence. Development of expertise in the scientific, technical, medical and clinical aspects of BMT products and the disease states they aim to treat. Product Development Activities Contribute to the development of new technologies and products by identifying unmet clinical needs. Identify potential product enhancement & new product ideas by understanding and applying the clinical needs of cardiologists and radiologists. Participate in product roadmaps activities for BMT’s medical devices. Engage early in formulation of product requirements. Conduct and provide competitive clinical analysis. Support development of communications/labeling materials. Serve as an internal expert on current clinical topics. Regulatory, Quality and Marketing Collaboration Activities Contribute to regulatory documents relevant to clinical studies and research. Support the development of medical device labeling including promotional material based on results of clinical research, including providing appropriate reference and support based on valid scientific evidence. Contribute to and review promotional materials including speaker decks, advertising materials, and white papers. Identify new clinical data developments, practices and guidelines in the current and potential future markets. Assigned as deputy Person Responsible for Regulatory Compliance as per SOP-500-01 Management Responsibility Required Skills Minimum Bachelor’s degree required, Master’s degree preferred. 10+ years of Clinical Affairs experience in the medical device industry. 10+ years of experience in medical writing, including authoring/overseeing Clinical Evaluation Reports. Expert knowledge of medical terminology and research methodology. Demonstrated ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors. Experience in accessing and appraising scientific, clinical evidence, including ability to perform relevant clinical literature searches using PubMED, MedLINE, EMBASE or other similar medical literature databases. Working experience with clinical and outcomes research study design, Good Clinical Practices and global clinical regulations, including FDA regulations and ICH guidelines for devices, biologics and/or pharmaceuticals. Experience in publication planning. Project management skills and experience with related tools (Microsoft Project). Ability to work independently, manage multiple tasks/projects, and self-motivate. Must be comfortable presenting in front of a group of peers, other company’s employees or customers. Strong attention to detail and the ability to handle multiple tasks. Excellent organizational, computer and documentation skills and an ability to prioritize effectively. Ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel. Strong document management skills including proficiency with MS Word, Outlook, Excel, etc. Strong written and verbal communication skills and interpersonal skills to effectively translate ideas, concepts and information. Preferred Masters or PhD in health sciences or medicine. 15+ years of Clinical Affairs experience in the medical device industry. 15+ years experience in medical writing, including authoring/overseeing Clinical Evaluation Reports. 7+years of people management experience in Clinical Affairs. Expert knowledge of cardiovascular interventional and diagnostics products and the ability to teach both internally and externally. Understanding of product development process. Working knowledge and experience with quality systems regulations and guidelines, ISO, cGMP, Medical Device Directive (MDD), Canadian Medical Device regulations, Japanese PAL and FDA regulatory requirements. Experience in providing case support to collect clinical research data in diagnostic/interventional cardiology procedures. Other Ability to travel to approximately six (6) conferences per year, domestic and international, plus additional physician meetings as required. **Compensation & Total Rewards: ** Estimated Starting Salary Range: $150,000 - $190,000 *Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position. Total Rewards: **Paid Time Off, Company Holidays & Paid Family Leave **– We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well. Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions. Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc. Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally. Choose – You won’t find “stuffy” here—whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible. Required Experience Qualifications: Minimum Bachelor’s degree required, Master’s degree preferred. 10+ years of Clinical Affairs experience in the medical device industry. 10+ years of experience in medical writing, including authoring/overseeing Clinical Evaluation Reports. Expert knowledge of medical terminology and research methodology. Demonstrated ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors. Experience in accessing and appraising scientific, clinical evidence, including ability to perform relevant clinical literature searches using PubMED, MedLINE, EMBASE or other similar medical literature databases. Working experience with clinical and outcomes research study design, Good Clinical Practices and global clinical regulations, including FDA regulations and ICH guidelines for devices, biologics and/or pharmaceuticals. Experience in publication planning. Project management skills and experience with related tools (Microsoft Project). Ability to work independently, manage multiple tasks/projects, and self-motivate. Must be comfortable presenting in front of a group of peers, other company’s employees or customers. Strong attention to detail and the ability to handle multiple tasks. Excellent organizational, computer and documentation skills and an ability to prioritize effectively. Ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel. Strong document management skills including proficiency with MS Word, Outlook, Excel, etc. Strong written and verbal communication skills and interpersonal skills to effectively translate ideas, concepts and information. Preferred Masters or PhD in health sciences or medicine. 15+ years of Clinical Affairs experience in the medical device industry. 15+ years experience in medical writing, including authoring/overseeing Clinical Evaluation Reports. 7+years of people management experience in Clinical Affairs. Expert knowledge of cardiovascular interventional and diagnostics products and the ability to teach both internally and externally. Understanding of product development process. Working knowledge and experience with quality systems regulations and guidelines, ISO, cGMP, Medical Device Directive (MDD), Canadian Medical Device regulations, Japanese PAL and FDA regulatory requirements. Experience in providing case support to collect clinical research data in diagnostic/interventional cardiology procedures. Other Ability to travel to approximately six (6) conferences per year, domestic and international, plus additional physician meetings as required. **Compensation & Total Rewards: ** Estimated Starting Salary Range: $150,000 - $190,000 *Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position. Total Rewards: **Paid Time Off, Company Holidays & Paid Family Leave **– We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well. Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions. Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc. Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally. Choose – You won’t find “stuffy” here—whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible. #J-18808-Ljbffr Core4ce Careers