Job Description

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. As a member of our team, youll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, to develop rapid groundbreaking solutions for the worlds most complex health challenges.

Are you a Clinical Research Scientist with experience in IVD, medical device or oncology clinical development?

Cepheid is looking for a Senior Clinical Research Scientist who develops and independently writes clinical documentation including clinical protocols, clinical study reports and clinical justifications in support of research and new product development, registration and commercialization of products. The scientist works on complex projects requiring state of the art knowledge in infectious diseases and oncology molecular diagnostics.

PRIMARY RESPONSIBILITIES:

* Work closely with cross-functional teams (Clinical Affairs, Medical Affairs, Regulatory, R&D, Quality) to strategize and compile clinical data to support current and new products submissions per Invitro Diagnostics Device (IVD) regulations.

* Provide scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.

* Assess clinical evidence and state of the art in medicine related to the Cepheid products and intended use to demonstrate safety and performance.

* Solves complex problems, proposes solutions, and exercises judgment based multiple sources of information

* Develop and write high quality clinical plans and reports with minimal supervision. Support development and drafting of clinical study protocols, and other study materials as needed.

* Collaborate with a multidisciplinary team in the development and, creation of study protocols in clinical procedures

* Prepare clinical study reports and critically-review clinical section for regulatory submissions

* Conduct comprehensive literature searches for product/technology evaluations and will write ad hoc reports based on these literature searches towards regulatory submission.

* Ensure that activities are conducted in compliance with current applicable regulations, laws and guidance including but not limited to US and EU regulation as well as with Cepheids policies and procedures.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES):

* Bachelors with 5+ years of experience OR, Masters with 3+ years of experience OR PhD with 0-2 years of experience

* Experience in the medical device or diagnostics industry, in particular within clinical development

* Strong interpersonal, problem-solving, written communication, and presentation skills

* Robust medical writing skills with a high sense of accuracy and keen sense of attention to detail.

* Performance-oriented with ability to work along agreed timelines with a focus on execution

* Fluent in English (verbal and written communication) and proficient in scientific writing, editing, proof reading skills, including spelling, grammar and formatting

PREFERRED QUALIFICATIONS:

* A Bachelors, Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology

* Strong scientific background with good understanding of infectious diseases, oncology and the molecular diagnostic area

* Experience with in vitro diagnostic (IVD) products, in molecular diagnostics or immunodiagnostics and oncology preferred

* Preferred experience in IVDD/IVDR or MDD/MDR regulations

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.