Senior Manager, Clinical Affairs
Business Unit: Strategic Procurement
Requisition Number: 235935
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
The clinical trials for molecular diagnostics products are usually pre-market applications (PMA) or 510(k) with special controls. These trials are complex, usually consisting of several sub studies.
- The Senior Manager, Clinical Affairs, Molecular Products is responsible for implementing strategies for the trials for regulatory filings, product modifications, and new markers.
- Management of clinical research associates and support staff to ensure timely execution of tasks in compliance with company’s procedures
- Responsible for adhering to regulations, guidelines and departmental standard operating procedures and monitoring proposed regulations and guidance documents that concern clinical trials and provide written responses where appropriate.
- Ensuring that the Clinical Affairs group remains compliant with all new regulations and requirements for clinical trial execution and documentation.
- Interactions with regulatory bodies to present clinical plans or clinical data in support of product approvals and registrations.
- Responsible for engaging clinical trial sites and managing relationships with principal investigators, key opinion leaders and key customers
- Provides input to budget and helps allocate expenses efficiently. Manages the clinical teams to execute contracts and ensures that clinical trials are performed within the required time frame.
- Represents the department at cross-functional project teams and business unit level
- Fully accountable for the results and achievements of the area.
- Serves as subject matter expert with contacts at various management levels concerning operationalizing clinical studies and scheduling of specific project phases.
Education & Experience
- Preferably, an MS or Ph.D. in a biological science, with a minimum of Bachelors degree in a scientific discipline or related field
- Minimum of 8+ years of experience in the area of clinical trials plus 3 years in a significant management role
- Experience in infectious disease products, including successful PMA and 510(k) submissions.
- Excellent communication skills, both verbal and written
- Excellent interpersonal skills, including excellent negotiation skills
- Excellent management skills and experience
- Knowledge of regulations concerning the conduct of clinical trials
- Good technical background to understand and communicate new technologies and markers
- Ability to manage multiple high priority projects
- A sense of urgency and the ability to instill this in the CA group
- Excellent relationships with a broad base of clinicians and laboratorians who can perform clinical trials and who have clinical populations appropriate for specimen acquisition a plus
- Laboratory experience is a plus