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

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.

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