Clinical Affairs Manager
T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies. We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter, or CFU/ml. Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis. Upon receiving regulatory clearance, we intend to commercialize T2Dx and T2 Candida and our goal is to launch these product candidates commercially in the United States in the first half of 2015.
T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014.
We are seeking a talented and highly motivated individual to join our team as the Clinical Affairs Manager. This position will report directly to the V.P., Clinical, Regulatory & QA.
Manage all aspects of T2 Biosystems’ clinical research in support of worldwide product approvals and company goals including the direction, planning, execution, analysis, and interpretation of clinical studies. Manage multiple projects, and interface with a variety of internal and external stakeholders. Solve complex problems where analysis of situations or data requires an in-depth evaluation of various factors and creative problem solving techniques. Provide hands-on execution of clinical trial activities as needed.
Minimum Education & Experience:
- B.S. degree in science or related field required
- 5+ years of medical device experience experience
- 3+ years people management experience
- Medical device/IVD industry experience required.
- Experience managing the design and implementation of clinical studies
- In-depth knowledge of domestic and international regulatory requirements relating to the clinical study of medical devices/IVDs required (e.g. FDA)
- Demonstrated leadership and self-motivation. Possesses the ability to motivate and guide subordinates and colleagues to meet objectives.
- Excellent communications skills (oral and written); proven ability to deal effectively with clinical practice thought leaders; effective communications to superior, peer and subordinate levels.
- Strong organizational and interpersonal skills.
- Demonstrable project management and creative problem solving skills.
- Hands-on capability in all areas of clinical trial execution.
- Experience writing scientific, FDA Clinical submissions and final study reports.
- Demonstrated skill in clinical research as evidenced by clinical publications and/or industry experience as evidenced by successful management of and participation in domestic and international clinical trials and associated regulatory submissions.
Travel: 25 - 35% travel required
Interested? Say hello to us and send a cover letter, along with your resume, to firstname.lastname@example.org. Please write the job title in the subject line.
T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.