Sr. Manager, Clinical Research & Programs

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

1. Identify new indications or new patient populations that could benefit from BMT’s products.
2. Identify the required level of clinical evidence for new projects.
3. Select and manage CROs and clinical contractors as necessary.
4. Contribute to long-term clinical strategies that support business objectives.
5. Develop and implement a PMCF strategy for BMT products.
6. Ensure the Clinical Affairs department operates at a state-of-the-art level in clinical evidence generation.
7. Build and maintain a strong network and close relationships with various internal and external parties.
8. Lead execution for both local and global studies, manages clinical research projects over all the BMT modalities.
9. Provide leadership for the conduct of clinical investigations as it applies to product approval and post-market clinical follow-up activities.
10. Support new product development by creating a clinical plan in conjunction with regulatory and R&D.
11. Oversee the design, plan and development of clinical trials.
12. Oversee the investigator-initiated research program to ensure alignment to the clinical research strategy set in collaboration with Marketing.
13. Develop and monitor financial budget of clinical programs, ensuring appropriate utilization of resources including staff, materials, and equipment.
14. Monitor progress and follow up when issues develop.
15. Work closely with clinical team members and cross-functional teams to ensure that budgets and schedules for deliverables are established and met.
16. Supervise and coordinate the work of the clinical team members.
17. Train, coach and develop team members to ensure consistency of deliverables across team.
18. Work closely with biostatisticians on statistical analysis plans and clinical data analysis.

Scientific Evidence Activities

1. 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).
2. Oversee the strategy, generation, and communication of the product-specific clinical development plans, including pre- and post-market clinical investigations and clinical evaluation reports.
3. Ensure that products have an updated clinical claims matrix.
4. Leadership of product-specific cross-functional clinical evidence collaboration teams to develop, interpret and utilize clinical evidence of products.
5. Clinical lead for creating the clinical claims matrix, working in conjunction with marketing product manager.
6. Responsible for the development of materials including reports, presentations and reviews to support scientific communications.
7. Maintain comprehensive literature database to provide in-depth knowledge and understanding of current clinical practices and research relevant to BMT products.
8. Identify clinical evidence gaps to build into BMT’s clinical research strategy.
9. Maintain and disseminate clinical summary information.
10. Contribute to materials on relevant clinical studies.
11. Collaborate cross-functionally the development and dissemination of new evidence.
12. 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

1. Contribute to the development of new technologies and products by identifying unmet clinical needs.
2. Identify potential product enhancement & new product ideas by understanding and applying the clinical needs of cardiologists and radiologists.
3. Participate in product roadmaps activities for BMT’s medical devices.
4. Engage early in formulation of product requirements.
5. Conduct and provide competitive clinical analysis.
6. Support development of communications/labeling materials.
7. Serve as an internal expert on current clinical topics.

Regulatory, Quality and Marketing Collaboration Activities

1. Contribute to regulatory documents relevant to clinical studies and research.
2. 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.
3. Contribute to and review promotional materials including speaker decks, advertising materials, and white papers.
4. Identify new clinical data developments, practices and guidelines in the current and potential future markets.
5. Assigned as deputy Person Responsible for Regulatory Compliance as per SOP-500-01 Management Responsibility.