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.

Education/Experience

Qualified candidates must have a MD with training in Internal Medicine. Subspecialty training in Endocrine and Metabolism or related therapeutic area preferred. PhD or PharmD degree candidates with extensive clinical development experience will be considered.

For MD, a minimum 2 years of hands-on industry experience in drug and clinical development is required. For PhD or Pharm. D, a minimum of 4 years of clinical development is required. Knowledge of pharmaceutical business, worldwide drug development and regulatory process are preferred. 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, self starting 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.

Education/Experience

Qualified candidates must have a PhD degree preferred or other advanced degree (i.e., MS or MBA) with additional relevant experience.

Minimum of 10 years experience in an R&D function within a biotech or pharmaceutical company with 5 years of pharmaceutical research and development project management experience, and an understanding of drug commercialization and marketing.

Demonstrated experience motivating and leading project teams to completing all activities associated with managing product candidates through all stages of development and registration including submission of at least one major NDA/MAA or major supplemental regulatory submission. This includes coordinating integrated drug development plans, project team meeting minutes, and project schedules.

Education/Experience

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.

Education/Experience

Qualified candidatees must have a Bachelors Degree in Computer Science, Life science, Engineering, Business Administration and / or a related discipline is required.Masters Degree in Life Science or Engineering or Information systems is preferred.

At least 4 years experience in working in pharmaceutical industry clinical research and development with its regulatory constraints, preferably with experience in 21 CFR Part 11; participating in multi-discipline implementation teams to deliver information systems on budget and against aggressive timelines; experience working with senior level scientific and/or professional staff in the Drug Development/Discovery area on the implementation and use of computer-based technologies; working with software and information technology providers; MS Project, PowerPoint, Access, Excel, Word; working knowledge of SDLC; and end-user support.

Ability to define, select and implement robust regulatory-compliant information systems solutions to support drug development. Understanding of scientific enterprise and business requirements gathering. Detail-oriented; ability to work independently.

Diplomatic and assertive user-facing skills (to manage and meet user expectations).

Business and technical problem-solving skills, including root-cause analysis, SWOT, and risk analysis.

Strong and persuasive interpersonal skills (to obtain cooperation across multiple functional areas – both internal and external – for on-time and on-budget project implementation). Strong oral and written communication skills.

Demonstrated technical skills in computer development environment (e.g., SQL, MySQL, R, S-Plus, SAS, Oracle, Perl, InforSense).

Education/Experience

Education/Experience:

Education/Experience

Qualified candidates must have a Ph.D. in Pharmaceutical science or equivalent.

Minimum requirement 8 years clinical pharmacology and pharmacokinetics experience, including implementation of state of art modeling and simulation to support compound development. Expertise in M&S in support of cardiovascular, oncology and diabetics preferred.

In-depth knowledge of current regulatory requirements (FDA, GCP and ICH).

Ability to work independently and to effectively prioritize, proactively identify and resolve problems and work in a team environment.

Must possess excellent communication and interpersonal skills, as well as effective collaboration and negotiation techniques.

Highly proficient in standard computer software (Word, Excel and Power Point) and helpful to have proficiency in specialized software for pharmacokinetic data analysis.

Demonstrated experience in population pharmacokinetic-pharmacodynamic modeling required using NONMEM. Experience in clinical trials simulation desirable.

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.

Education/Experience

BS or MS degree in Life Sciences is essential.

Experience in the pharmaceutical industry with more than 15 years of direct regulatory affairs experience. Working knowledge of laws, regulations and guidelines is essential. Experienced in filing INDs, NDAs in both paper and electronic formats. Experienced in managing an operations group.

Basic computer skills (MS Word, Excel and Acrobat) are vital. Knowledge of InSight Publisher and Microsoft Project are a plus.

Education/Experience

Education/Experience

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.

Education/Experience