|
Search Jobs
|
Page 1 |
2 |
3
| >>
|
| Daiichi Sankyo, Inc. |
Parsippany |
NJ |
7/30/2010
|
| Sr. Director, Pharmacoepidemiology and Outcomes Research |
Education/Experience Qualified candidates must have a Ph.D. in Epidemiology (or related field) or M.D. with advanced training in Epidemiology and a minimum of 8 years of experience in overseeing/conducting pharmacoepidemiological research in the pharmaceutical industry or a consulting organization. Experience in cardiovascular and oncology pharmacoepidemiological & outcomes research is preferred. Proficiency in scientific literature synthesis and clinical/retrospective database management and analyses utilizing inferential biostatistics (multiple regression, ANOVA, survival analysis, etc); and designing and applying appropriate multivariate statistical techniques in pharmacoepidemiological and health economics & outcomes research projects. Must be willing to travel 10% of the time. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Manager QA Computer System Validation |
Education/Experience Qualified candidates had a minimum of 5 years experience with a world class pharmaceutical quality organization; first hand knowledge of computer system validation related to pharmaceutical manufacturing, clinical development, QC/QA, and regulatory affairs; and experience in auditing computer system validation/software development life cycle (SDLC) processes. Direct dealings with FDA and other regulatory agencies is a plus. Strong appreciation of the impact of regulatory bodies on pharmaceutical operations.International experience is a plus; but at minimum, experiences working with diverse cultures and employees. Quality processes and regulations (e.g., cGMP, GCP, and GLP regulations) Computer system validation/SDLC processes; auditing skills; risk management skills Sets high performance expectations and holds others responsible for the expected results. Acts with a sense of urgency; is able to work with a wide variety of people and takes actions that are best for Daiichi Sankyo versus any individual operating group. Enhances performance by doing things that are unique and takes well-calculated risks in decision making. Adapts easily to new circumstances and is flexible in a work environment that makes frequent changes in its demands. Coaches both internal and external employees on ways to improve performance. Encourages the free exchange of information and opinion even when they may be negative or unpopular. Asks for support from others when necessary and genuinely respects their point of view. Demonstrates respect for and capitalizes on cultural diversity and seeks out perspectives when developing strategies, both international and domestic. Has a natural “can-do” attitude and approach to issues and instills this attitude in others. Takes ownership of processes and results regardless of their outcome. Realizes the contribution that others are making and gives credit to them when appropriate. Creates an environment that enhances trust. Demonstrates principled leadership and ethics and expects the same from others. Must be willing to commute 20% of time. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Director Risk Management |
Education/Experience MD (or PhD in a relevant scientific discipline), Board certification or eligibility. 3-5 years experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology. Senior Director 7- 10 years. Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist. Ability to review and analyze data and communicate complex information and analyses to a variety of scientific and non-scientific audiences. Proven ability to think creatively and to develop strategic plans that demonstrate sound judgment. Experience working cross-culturally in a global pharmaceutical environment. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Associate Director Experimental Medicine |
Education/Experience MD or PhD in Life Sciences. At least 3 years of academic or 2 year of pharmaceutical industry experience (preferably in experimental medicine, translational medicine, or clinical pharmacology), with experience in a role having primary responsibility for design and conduct of Phase 1 study protocols. Experience across multiple therapeutic areas is very desirable. Ability to work with minimal supervision to identify, prioritize and resolve problems. Ability to work effectively in a team environment. Strategic orientation with evidence of implementation and oversight of novel methodological approaches coupled with a strong focus on set up and conduct of exploratory clinical studies. Must have had personal experience and involvement within project teams in issues around design and conduct of Phase 1 studies. Familiarity with ICH, FDA and GCP guidelines governing clinical trial design and conduct, biomarkers, pharmacogenomics and clinical technologies. Ability to collaborate with interdisciplinary functions within and outside Daiichi Sankyo on effective set up and execution of Experimental Medicine Phase 1 studies. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Project Data Manager |
Education/Experience Qualified canddiates must have a Master's degree; Bachelors degree or registered nurse in life sciences; 4 to 6 years (MS) pharmaceutical/data management; 6 to 8 years (BS/RN) pharmaceutical/data management. Project management experience is preferred. Demonstrated knowledge of clinical data flow and research design; clinical database administration and system validation experience; demonstrated competence with GCP/regional regulatory guidelines, SOPs (including WPs), medical terminology, standard coding dictionaries, and demonstrated proficiency in applying them to all relevant therapeutic areas and CRO management experience, including a thorough knowledge of CRO audits are critical skills in this role. EDC and SDTM experience is preferred. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| 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. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| 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 |
7/30/2010
|
| Sr Scientist Clinical Pharmacogenomics |
Education/Experience Qualified candidates must have MD, PharmD, or PhD in Life Sciences. Minimum requirement 0-5 years; Background of academic or pharmaceutical industry research experience, with a role having responsibility for pharmacogenomic strategies in clinical research projects. Experience leading clinical research studies is very desirable. Post-doctoral training/experience is also very desirable. Proven strong science background as evidenced by a good publication record. Ability to work with minimal supervision to identify, prioritize and resolve problems. Ability to work effectively in a team environment. Strategic orientation with evidence of implementation and oversight of clinical pharmacogenomic plans and/or studies. Familiarity with ICH, FDA and GCP guidelines to effectively provide guidance around clinical trial design and the medical, ethical, legal and social issues concerning pharmacogenomics. Ability to collaborate with interdisciplinary functions within and outside Daiichi Sankyo to implement novel pharmacogenomic research activities. Must be willing to travel 10% of time. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| 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. |
Edison |
NJ |
7/30/2010
|
| Sr. Director, Clinical Development, Oncology |
Education/Experience Qualified candidates must have a MD and a minimum 5 years of pharmaceutical development experience and at least 3 years of hands-on experience managing a major, multi-country, clinical program. Must be an Oncologist. Knowledge of pharmaceutical business, worldwide drug development and regulatory process. Expertise in complex clinical trial design (i.e. factorial design, etc.) and complex implementation (i.e. including Steering Committees, Safety Monitoring Boards, etc.) as well as the interpretation of scientific data. Independent thinking, creativity and innovation. Ability to deliver high quality products. Strong interpersonal skills and ability to interface effectively with multinational development teams in a multicultural working environment. Excellent communication, presentation and negotiation skills with emphasis on building consensus. Ability to effectively manage interactions with academic thought leaders ensuring optimal cooperation for achieving program and department goals. Ability to anticipate and facilitate issue resolution in a multicultural working and business environment. |
|
Page 1 |
2 |
3
| >>
|
|
