1+ months

Director of Clinical Affairs

Berkeley, CA
**Director of Clinical Affairs**

Locations:Berkeley, California

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Strategic Procurement

**Requisition Number:** 222709

**Primary Location:** United States-California-Berkeley

**Assignment Category:** Full-time regular

**Experience Level:** Senior level

**Education Required Level:** Master's Degree

**Travel Required:** 20%

**Division Description:**


is a global technology powerhouse that has stood for engineering excellence,

innovation, quality, reliability and internationality for more than 165 years.

As a global technology company, Siemens is rigorously leveraging the advantages

that this setup provides. To tap business opportunities in both new and

established markets, the Company is organized in nine Divisions: Power and Gas,

Wind Power and Renewables, Energy Management, Building Technologies, Mobility,

Digital Factory, Process Industries and Drives, Healthineers and Financial


With 45,000 employees Siemens Healthineers is one of the worlds largest

suppliers of technology to the healthcare industry and a leader in medical

imaging, laboratory diagnostics and healthcare IT. All supported by a

comprehensive portfolio of clinical consulting, training, and services

available across the globe and tailored to customers needs. So that more

people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthcare

**Job Description:**

The Director

of Clinical Affairs is responsible for devising and executing clinical trial

strategies for Molecular In-Vitro Diagnostics products using PCR technology.The Director will define the clinical requirements for

a wide range of assays and drive the clinical development and validation

strategies, and he/shewill collaborate with other teams internationally

to successfully deliver multiple PMA and 510(k) submissions in the United

States and CE-IVD marking under the IVDD and/or the IVDR in the EU. These

trials are complex, consisting of several sub-studies and multiple clinical



include representing clinical affairs in strategic projects, oversight of the

timely execution and compliance of clinical trials, and preparation of regulatory

submissions. This role requires

monitoring of proposed regulations and guidance documents related to clinical

trials, while ensuring that all clinical activities remain compliant with these

requirements. In addition, the Director will serve as a scientific and clinical

liaison between internal teams and external groups such as CROs, regulatory

authorities, professional and public health organizations, key opinion leaders,

and advisory boards.He/she

will be responsible for devising the medical strategy for new products and

their potential medical value, while defining potential clinical utility for

company products. The position provides senior clinical

leadership internationally and across functions andreports to

the Head of Quality and Technology, located in Berkeley, California.

**E** **du** **c** **ation and Experience**

+ An M.S.orPh.D, preferablyinareasofmicrobiology,virology, or immunology

+ 10+ years of experience inclinical trial research and regulatory submissions (PMA and 510k), supportingnew product launches as well as product updates in the IVD or MolecularDiagnostics field

+ 5+ years of managementexperience, with proven track record of delivering projects on time andpromoting high performance behaviors within a team

+ Thoroughknowledge of clinical trial design and statistical methods for clinicalresearch

+ Familiarity with international regulations for IVDClinical Trials and prior experience in the acquisition and management ofclinical trial samples

+ Demonstratedability to design studies, and write and review the resulting study reports andpublications

+ Understandingof molecular and virology laboratory techniques

+ Prior experience working with cross-functionalproject teams, IRBs and business partners

+ Fluency with Microsoft Office and Microsoft Outlook

**Requi** **redKnowledge/Skills**

+ Experiencein interfacing with key opinion leaders including physicians and clinicallaboratorians

+ Provides medical expertise and leadership to theClinical, Regulatory, Quality, Research, Development, and Marketing groups

+ Agile and flexible team player with the ability tomeet project timelines, complete clinical affairs deliverables, andbuild and foster global relationshipsto meet all regulatory requirements related to clinical trials

+ Understanding of regulations and guidelinesgoverning the areas of medical device and in-vitro diagnostic development, witha broad knowledge of requirements and best practices in Clinical Affairs,Regulatory Affairs and Product Development

+ Ability toassist Research and Development Groups with assay design and the design ofperformance verification and troubleshooting experiments.

+ Proven ability to multitask, collaborate incross-functional teams, and work independently

+ Excellent communication skills and workingknowledge of English grammar, punctuation and overall writing skills, with theability write clinical trial reports and documentation independently

+ Critical-thinker with excellent negotiation skillsand the ability to address complex situations independently, and the ability toadopt a systemic view of continuous process improvement to support businessgoals and decisions

+ Proven ability to manage multiple time-sensitivehigh priority projects

+ Ability to develop or revise clinical trialprocedures and processes

+ Willingness to travel up to 30%

**PreferredKnowledge/Skills, Education, and Experience**

+ Excellent relationshipswith a broad base of clinicians and laboratorians who can perform field orclinical trials and who have clinical populations appropriate for specimenacquisition

+ Direct Laboratoryexperience

+ Professionaldesignationsarenotrequired,buttrainingandcertificatesinqualityorregulatoryaffairsisaplus( _e.g_ _._ ,CQM,CQE,CQA,RAC,CLIA,SixSigma,LeanPrinciples)


**Equal Employment Opportunity Statement**

Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

**EEO is the Law**

Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

**Pay Transparency Non-Discrimination Provision**

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


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Director of Clinical Affairs

Berkeley, CA

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