Danaher Corporation Senior Clinical Research Scientist - IVD in New York, New York
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications.
Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).
Make an Immediate Impact on a Global Scale At Cepheid, the work you do every day will impact patient care around the world.
You’ll be inspired and invigorated, knowing that you’re part of the team helping to diagnose the most challenging diseases. And you can be proud knowing you work for a company with the highest integrity, creating the quality products clinicians around the world depend on to deliver better, faster diagnosis for the most vulnerable patients.
This can be a REMOTE role!!!
Are you a Senior Clinical Research Scientist with experience developing and independently writing 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.
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 Cepheid’s policies and procedures.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES):
Bachelor’s with 5+ years, Masters with 3+ years or PhD or equivalent experience
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
A Bachelor’s, Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology
5+ years of relevant experience in the medical device or diagnostics industry, in particular within clinical development
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.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or firstname.lastname@example.org to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid