Senior Manager Clinical Research

4 weeks ago

TX United States Abbott Full time
Job Summary

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

We are seeking a Senior Manager, Clinical Research to join our rapidly growing clinical team within Abbott Neuromodulation. This position will lead clinical evidence generation activities associated with Neuromodulation products, primarily within the DBS therapies for movement disorders and psychiatric disorders.

The successful candidate will have a strong background in clinical research, with experience in medical devices and a deep understanding of movement disorders, brain therapies, depression or other psychiatric disorders or neuromodulation therapies.

Key Responsibilities
  • Manage and lead the clinical evidence generation for DBS products, including the design and conduct of clinical studies, from prospective pre-market and post-market studies to RWE data generation.
  • Lead the process of clinical evidence generation for medical devices, by collaborating closely with the statistician, medical affairs, and regulatory affairs personnel, that appropriately satisfy the needs of the business as determined by marketing and reimbursement organizations.
  • Provide scientific justification to trial design and ongoing scientific analyses during protocol development and provide scientific guidance to the development of statistical analyses plans.
  • Contribute to the scientific analyses, presentation, and interpretation of clinical data generated from Abbott-sponsored clinical studies.
  • Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area.
  • Lead study-level (and franchise-level where applicable) publication planning, and ensure successful execution of the publication plan.
  • Collaborate closely with external stakeholders, including physician investigators and key opinion leaders, and successfully represent Abbott as the primary scientific expert for the therapy.
  • Generate clinical strategy and documents to support pre and post-market regulatory medical devices submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions.
  • Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts.
  • Contribute to the optimization of internal processes and workflows.
  • Participate in and oversee scientific report writing. Presentation of methods, results, and conclusions to a publishable standard.
  • Contribute to planning and execution of collaborative projects with leading academic and commercial research groups worldwide.
  • Develop new ideas for both external and internal projects.
  • Attend and prepare for meetings with global regulatory agencies involving clinical data.
Accountability Scope and Budget
  • Understand the business environment and relate extensive knowledge of internal and external technological activities to trends.
  • Interface with senior management on significant matters, often requiring the coordination of activity across organizational units.
  • Participate in the development of other technical contributors by facilitating training and providing feedback and guidance.
  • Elevate potential changes in regulatory or clinical environment to leadership.
  • Prioritize across teams to ensure strategic goals/milestones within Clinical Development are met.
  • Provide technical leadership to business units, physicians, and oversee and direct external CROs and medical writers.
  • Act as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
Qualifications
  • Minimum requirements: MS in medical or scientific field alongside relevant clinical research experience in medical devices is required. Preference for a PhD in biomedical engineering, biological sciences, biostatistics, or related field.
  • 5+ years of related clinical research for medical devices work experience with in-depth knowledge of movement disorders, brain therapies, depression or other psychiatric disorders or neuromodulation therapies.
  • Experience in data analytics, image processing, or brain imaging is a plus.
  • Demonstrated ability to solve problems independently by taking into account multiple points of view.
  • Ability to work within a team and as a manager to other scientists in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.
  • Demonstrated skill and tactfulness in working as a cross-functional team member.
  • Experience in clinical research studies collaborating with cross-functional clinical research partners, physicians, and other healthcare providers.
  • Well-organized and self-motivated with an ability to initiate and follow through on assignments.
Key Attributes Considered Necessary for Success
  • Ability to work collaboratively, internally and externally.
  • Ability to manage/prioritize multiple tasks and adapt to a changing, fast-paced environment.
  • Ability to work in a group environment.
  • Ability to drive effective communication with a cross-functional team.
  • Excellent oral and written communication skills.
  • Highly analytical.
  • Strong interpersonal skills, including influencing, negotiation, and teamwork skills.

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