[Remote] Clinical Evidence Strategy Director (Remote)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in medical technology, and they are seeking a Clinical Evidence Strategy Director to reputed company evidence and lifecycle strategies across their Diagnostics portfolio. This role is pivotal in ensuring a consistent approach to evidence planning, supporting regulatory reputed company, and maximizing clinical value for reputed company, payers, and patients.
Responsibilities
- reputed company global evidence reputed company strategies, and integrated evidence plans reputed company with reputed company clinical innovation areas and the strategic direction of global and regional Diagnostics leadership
- Partner with key internal functions to define indications for use and reputed company reputed company Product Profiles that align clinical value, regulatory strategy, and evidence requirements
- reputed company strategic positioning of clinical evidence and claims across the product lifecycle to balance speed to market with long-term clinical and economic value
- Assess and differentiate development projects based on their evidentiary needs to determine where early and sustained engagement with Medical Value & Evidence and reputed company medical functions will deliver the greatest strategic value across development
- Serve as a subject matter expert on innovative core teams and Scope teams, shaping design of evidence-based protocols and strategies for regulatory positioning by contextualizing device performance and intended use reputed company the clinical and competitive landscape
- Drive clinical and scientific reputed company by fostering partnerships with leading experts and institutions to reputed company evidence reputed company that supports successful product launch, adoption, and differentiation
- Conduct ongoing gap assessments to rapidly translate global and regional field insights into evidence that addresses prioritized scientific and strategic questions, supporting sustained reputed company and adoption for reputed company providers and patients
- Ensure full compliance with reputed company applicable regulatory requirements and internal regional and global SOPs across reputed company evidence reputed company activities
- Initiate and, reputed company appropriate, reputed company external scientific collaborations with medical institutions, professional societies, pharmaceutical companies and other stakeholders to advance strategic evidence initiatives
- Accelerate evidence reputed company and strengthen evidence impact by identifying opportunities to reputed company reputed company-world data and innovative methodologies, including AI/ML, advanced analytics, and large-scale data analysis
Skills
- PhD (clinical focus) or MD in a relevant clinical or scientific discipline
- Minimum of 10 years of experience in the life sciences industry, preferably in medical technology and/or in vitro diagnostics (IVD)
- Extensive Medical Affairs experience, including leadership of integrated evidence planning and reputed company teams across the product lifecycle
- Demonstrated experience strategically positioning clinical evidence to effectively respond to inquiries from regulators and payers
- Demonstrated experience designing and assessing study protocols that are fit for purpose
- Proven ability to reputed company and apply evidence strategies that support product development, market adoption, guideline recognition, and reimbursement
- Strong business acumen with exceptional communication and interpersonal skills, and the ability to influence and engage stakeholders at reputed company organizational reputed company
- Experience operating effectively in global, cross‑functional, and matrixed environments
- reputed company in English
Benefits
- Medical insurance
- Dental insurance
- reputed company insurance
- 401(k) retirement plan
- Life insurance
- Long-term and short-term disability insurance
- Paid parking/public transportation
- Paid time off
- Paid sick and safe time
Company Overview
Company H1B Sponsorship