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| Daiichi Sankyo, Inc. |
Edison |
NJ |
9/9/2010
|
| Clinical Study Manager |
Education/Experience
Bachelor’s Degree in Life Sciences or higher. A minimum of 3 years of experience in clinical research (at least 2 of these in Clinical Development) in pharmaceutical or device company, Academic Research Organization or CRO with BS. Minimum of 2 years of clinical research experience with MS, MPH, PhD or higher. Complete understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Proficient skills in computer applications such as Word, Excel, and PowerPoint. Strong oral and written communication skills. Complete knowledge of GCP, FDA CFRs and ICH Guidelines. Ability to interpret data and to present results in a concise and clear manner. Management and leadership skills to contractors to the successful completion of the project. Working knowledge of the components and key content requirements of IND & NDAs. |
| Daiichi Sankyo, Inc. |
Parsippany |
NJ |
9/9/2010
|
| Project Data Manager |
Education/Experience Qualified candidates must have a Bachelor's degree or Registered Nurse with a minimum of 6 years pharmaceutical/data management experience or a Master's degree plus a minimum of 4 years experience in pharmaceutical/data management. Project management experience is preferred. Clinical database administration and system validation experience; CRO management experience; and demonstrated knowledge of clinical data flow and research design are critical skills in this role. |
| Daiichi Sankyo, Inc. |
Parsippany |
NJ |
9/9/2010
|
| Exec. Medical Dir Medical Research TA Head - Hypertension & Metabolism |
Education/Experience Qualified candidates must have a MD degree with a minimum of 10 years experience in clinical, research or academic medicine and a minimum of 7 years of pharmaceutical industry experience; leadership experience managing scientific staff; and experience with cardiovascular medical strategies and clinical trial implementations. Advanced training in cardiovascular medicine is highly desired. Experience in the business development area would be a plus. Excellent written and oral communication skills, particularly strong formal presentation skills; strong interpersonal skills commensurate with the need to work closely with outside physicians/ scientists and numerous in-house support groups; knowledge of scientific methods, research design and medical practices and procedures that would be acquired through clinical experience and clinical research studies; good understanding of the current legal and regulatory environment are critical skills in this role. Basic knowledge and appropriate application of biostatistics is required in this role. Additional training in the area of cardiovascular medicine is highly desired; experience with hypertension and metabolism products are required Must be willing to travel up to 40% with up to 10% international travel. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
9/9/2010
|
| Staff Biostatistician |
| Education/Experience Qualified candidates must have Statistics, Biostatistics, or Mathematics: MS or PhD. PhD + 8 yrs or MS + 10 years of pharmaceutical industry experience; full knowledge of advanced statistical analytical methods, clinical trial research, regulatory requirements, coding techniques, and statistical software. Excellent oral and written communication skills; project planning skills; demonstrated experience in analyzing clinical trial data; priority setting skills; multi-tasking skills; problem solving skills; eye for detail; exercise good judgment; and works well within team framework. Comprehensive project management skills. Demonstrated competency in SAS. Regular attendance at IDT Meetings is necessary; experience in managing CROs and external vendors. |
| Daiichi Sankyo, Inc. |
Parsippany |
NJ |
9/9/2010
|
| Sr Director Health Economics and Outcomes Research |
Education/Experience Qualified candidates must have a Doctoral degree in Health Economics, Health Services Research, Medicine, Public Health, or Pharmacoepidemiology and a minimum of 12 years relevant experience in the healthcare industry with at least 8 years within a pharmaceutical company. Must have atleast 3 years of successful leadership and people management experience (HEOR specific), with five or more years preferred, and track record of effective application of HEOR data with external stakeholders in the United States and International markets clearly tied to successful business outcomes is required. Combination of leadership and hands on experience with HEOR research methodologies during all phases of product life cycle and knowledge of cardiology and oncology disease is preferred. Strong leadership and managerial skills, and ability to successfully influence cross functional teams including senior level clinical and commercial colleagues in order to drive the “value proposition” development agenda are critical skills in this role. Must be willing to travel 20% of time. |
| Daiichi Sankyo, Inc. |
Parsippany |
NJ |
9/9/2010
|
| Director, Biostatistics and Data Management |
Education/Experience Qualified candidates must have a MS in Statistics, Biostatistics, or Mathematics with a minimum of 15 years of pharmaceutical industry experience or a PhD in Statistics, Biostatistics, or Mathematics with a minimum of 10 years of pharmaceutical industry experience. Extensive experience analyzing clinical trial data; experience managing external contracted resources required; direct personnel management experience is preferred. The incumbent must have full knowledge of advanced statistical analytical methods, data management, clinical trial research, regulatory requirements, programming skills, and statistical software. Demonstrated mastery of advanced statistical analytical methods, competency in SAS, clinical trial search, regulatory requirements; coding techniques, protocol development and personal computing. |
| Daiichi Sankyo, Inc. |
Parsippany |
NJ |
9/9/2010
|
| Exec. Medical Dir Medical Research TA Head - Oncology |
Education/Experience Qualified candidates must have a MD degree with a minimum of 10 years experience in oncology clinical, research or academic medicine and either a minimum of 7 years of pharmaceutical industry experience or 15 years experience in academic medicine with experience conducting industry sponsored trials. Experience with oncology medical strategies and clinical trial implementations are required. Leadership experience managing scientific staff is required. Subspecialty training in the area of oncology is highly desired. Experience in the business development area would be a plus. Excellent written and oral communication skills, particularly strong formal presentation skills; strong interpersonal skills commensurate with the need to work closely with outside physicians/ scientists and numerous in-house support groups; knowledge of scientific methods, research design and medical practices and procedures that would be acquired through clinical experience and clinical research studies; good understanding of the current legal and regulatory environment are critical skills in this role. Basic knowledge and appropriate application of biostatistics is required in this role. Must be willing to travel up to 40% with up to 10% international travel. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
9/9/2010
|
| Clinical Study Manager |
Education/Experience Qualified candidates must have Bachelor’s Degree in Life Sciences or higher. A minimum of 3 years of experience in clinical research (at least 2 of these in Clinical Development) in pharmaceutical or device company, Academic Research Organization or CRO with BS. Minimum of 2 years of clinical research experience with MS, MPH, PhD or higher. Complete understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Proficient skills in computer applications such as Word, Excel, and PowerPoint. Strong oral and written communication skills. Complete knowledge of GCP, FDA CFRs and ICH Guidelines. Ability to interpret data and to present results in a concise and clear manner. Management and leadership skills to contractors to the successful completion of the project. Working knowledge of the components and key content requirements of IND & NDAs. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
9/9/2010
|
| CMO Manager |
Education/Experience Qualified candidates must have a Master's degree in biology, microbiology, biochemistry, or chemical engineering with a minimum of 5 years experience, or a Bachelor's degree with a minimum of 8 years experience of hands on clinical and/or commercial industry experience in the manufacturing science of biologics (mAbs) and/or cell based therapeutics. Interaction with contract manufacturing organizations and biotech product companies is required and technology transfer and process scale-up are a plus. The skills needed for this position are adequate knowledge of cGMPs, regulatory requirements, and CMC operations in a biotech company; and excellent negotiation and communication skills. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
9/9/2010
|
| Manager, Medical Writing |
Education/Experience Qualified candidates must have a PharmD, PhD in biological sciences. MD is strongly preferred. Otherwise exceptional candidates with a MS or BS/BA may be considered. Minimum requirement of 3 years experience with PharmD or PhD, 5 years with Masters’ Degree or 7 years with a BA/BS. Experience in writing regulatory documents (protocols, Investigator Brochures [IBs], Clinical Study Reports (CSRs), clinical sections of the CTD [2.5, 2.7.3, 2.7.4], integrated summaries of efficacy and safety [ISE and ISS], briefing books, and regulatory responses) in the pharmaceutical or CRO environment required; ability to interpret and organize scientific data; and general understanding of clinical research, biostatistics, electronic publishing, and relevant industry guidelines (GCP, eCTD, and ICH). Marketing submission experience (NDAs or MAAs) preferred but not required. Daiichi Sankyo develops or has developed drugs in the following therapeutic areas: cardiovascular diseases, metabolic diseases, inflammation and immunology, infectious diseases, and oncology. Relevant therapeutic area experience preferred. Ability to quickly get up to speed on a therapeutic area, project, or indication with little to no coaching, work concurrently on several complex projects, meet aggressive deadlines, and adjust priorities rapidly as the situation demands. Strong interpersonal and communication skills (both verbal and written) are also required as the individual must be able to work in a team environment and coordinate with the team to move documents forward to completion. Must be a self-motivated person who can work with limited guidance/supervision. Excellent writing skills with a clear concise style and excellent grammar, punctuation, and spelling; proficiency in a Microsoft Windows environment; and strong MS Word skills and ability to work with templates. Excellent attention to details, especially as related to accuracy of numbers/statements and consistency within and across documents. |
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