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Danaher Corporation Study Manager, Medical/Scientific Affairs & Strategy, Oncology (MSASO) in New Haven, Connecticut

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.

The Study Manager, Medical/Scientific Affairs & Strategy, Oncology for Cepheid, leader in molecular diagnostics, is responsible for preclinical and post-marketing studies & research responsibilities that drive significant impact to the organization.

This can be a US based remote position preferably in a major city in the US Eastern or Central time zone..

This position is part of the Scientific and Medical Affairs group and can work remotely. Medical and Scientific Affairs and Strategy, Oncology is responsible for leading operational activities for new and/or ongoing cancer diagnostic test preclinical and post-marketing clinical studies and research in the US and Globally!

Job Responsibilities:

  • Implements strategies and designs for preclinical or post-marketing MSASO studies & research collaborations in support of Cepheid Oncology products.

  • Runs operational aspects of assigned projects, from study/collaboration planning, protocol development, contracts, study initiation, forecasting and ordering of study supplies, training of on- site personnel, study monitoring with on-site audits of clinical data as needed, tracking study progress and budget milestones, and study close out visits.

  • Develops project budgets, schedules, and ensures performance requirements are met. Leads global clinical study resource needs in conjunction with the EU-based study manager, Sr. Director and the VP of MSASO to ensure projects are resourced appropriately.

  • Leads the development of study-specific documents (e.g. monitoring plans, data collection forms/eCRFs, informed consents, and other documents as required).

  • Reports study progress/milestones to VP and Sr. Director, MSASO, and relevant departments.

  • Interacts with Government Affairs & Market Access (GAMA), Clinical Affairs and Regulatory Affairs, and Marketing regarding scientific evidence needed in support of product registration and successful product launch.

  • Identifies problems or issues that could affect the results or timely completion of the study, or any protocol deviations, and suggests mechanisms to solve the problem(s).

  • Stays up to date on major advances in cancer detection, diagnosis, and monitoring, and the use of new tests and advances in clinical practice.

  • May serve as a delegate for the Med-Sci Oncology function on core teams and act as a cross functional liaison to ensure overall product study plans align with clinical needs and business development strategies.

Training responsibilities:

  • Complete all assigned and required training satisfactorily and on time.

Minimum requirements:

Education and Experience (in years):

  • A college degree in a scientific, biological or medical science discipline (Clinical Sciences, Health/Life Sciences, Nursing, Molecular Biology, Biochemistry and/or Human Physiology) is required as follows:

  • Bachelor’s degree in field with 5+ years of related work experience OR Master’s degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience.

  • Minimum of 2-5 years experience in managing performance studies of In Vitro Diagnostic (IVD) products.

Knowledge and skills:

  • Excellent verbal and written English language skills, including the ability to write excellent study protocols and study reports. Ability to work on multiple projects simultaneously.

  • Knowledge of clinical trial design, and current regulatory/compliance and clinical requirements for diagnostic products, including post-marketing studies.

  • Proficient with Microsoft Office applications, such as Word, Excel, Access, Powerpoint.

  • Good understanding of cancer biology and molecular diagnostics, medical terminology, and laboratory testing.

  • Knowledge of GCP & ICH guidelines and FDA regulations; bonus if the candidate has knowledge of IVDR regulations in EU.

  • Fluency/proficiency with other languages besides English is a plus but is not required.

  • Excellent organizational skills and willingness to continuously improve together with the business.

Other: Travel

  • Approximately 10-35% travel (once COVID-19 travel restrictions are lifted)

Preferred requirements:

  • A Masters or PhD/Professional degree in a Scientific Discipline, preferably biological or medical science discipline

  • 5+ years of IVD experience.

  • Experience working in oncology / oncology diagnostics

  • Experience as a Clinical Research Associate (CRA) or Clinical Study Manager in IVD industry and/or experience in running post-marketing Medical-Scientific Affairs sponsored studies, investigator initiated research program/studies, and preclinical research studies of molecular in vitro diagnostics.

  • Knowledge of how to apply clinical development expertise to create excellent clinical protocols

#remote

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 is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Operating Company: Cepheid

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