Note: The job is a remote job and is open to candidates in USA. Siemens Healthineers is a leader in medical technology, and they are seeking a Clinical Evidence Strategy Director to oversee evidence and lifecycle strategies across their Diagnostics portfolio. This role is pivotal in ensuring a consistent approach to evidence planning, supporting regulatory success, and maximizing clinical value for healthcare professionals, payers, and patients.
Responsibilities
- Develop global evidence generation strategies, and integrated evidence plans aligned with priority clinical innovation areas and the strategic direction of global and regional Diagnostics leadership
- Partner with key internal functions to define indications for use and develop Target Product Profiles that align clinical value, regulatory strategy, and evidence requirements
- Lead 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 related 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 within the clinical and competitive landscape
- Drive clinical and scientific excellence by fostering partnerships with leading experts and institutions to enable evidence generation 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 access and adoption for healthcare providers and patients
- Ensure full compliance with all applicable regulatory requirements and internal regional and global SOPs across all evidence generation activities
- Initiate and, when appropriate, lead external scientific collaborations with medical institutions, professional societies, pharmaceutical companies and other stakeholders to advance strategic evidence initiatives
- Accelerate evidence generation and strengthen evidence impact by identifying opportunities to leverage real-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 generation 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 develop 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 all organizational levels
- Experience operating effectively in global, cross‑functional, and matrixed environments
- Fluency in English
Benefits
- Medical insurance
- Dental insurance
- Vision 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