What are the responsibilities and job description for the Associate Director, Clinical Development (W2 Role, 10+y exp) position at IT ENGAGEMENTS INC?
Job Description
Job Description
Greetings from IT Engagements
Role : Associate Director, Clinical Develpment (W2 Role)
Remote
Job Category : Research & Development
Duties :
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
May determine methods and procedures on new assignments. Serves as an in-house consultant. May act as spokes person on corporate research / technology / development and advise senior management.
Leads in the use of professional and scientific concepts to contribute to the development of company concepts and principles to achieve objectives in creative and effective ways.
Synthesizes multiple data sources and draws general, non-obvious conclusions. Defines complex problems, develops approaches and develops experiments with sound judgment.
Assists in development of regulatory filings. Interfaces with various departments, customers and partners. Assists the Commercial team in developing concepts. Puts work practices in context with larger team and participates in the implementation of change when required.
Plans and coordinates activities with other team members. Writes and / or approves complex reports and protocols.
Skills :
A minimum of 5 years work experience in a pharmaceutical, CRO or biotech environment required. Experience in immunology (Rheumatoid Arthritis, Atopic dermatitis, ulcerative colietis, alopecia areata, etc.) highly preferred.
The ideal candidate will have the following :
Phase 2 or late-stage drug development experience
Experience with data analysis and interpretation as an understanding of safety and PV principles
Well-versed in clinical data review, including : data listings, patient profiles, drug class identification and adverse event review
Ability to evaluate, interpret and present complex scientific data
Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought.
Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment.
Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work.
Must possess good oral and written communication skills.
Ability to present technical information to both technical and non-technical audiences is required.
Must be able to demonstrate sound judgment.
Must be able to demonstrate problem solving capabilities. Strong organizational skills are required.
Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus.
Experience working in an FDA regulated environment and knowledge of current GMPs.
Education :
A PharmD or PhD in a scientific discipline is required. Equivalent experience may be accepted.
Required Skills :
ORGANIZATIONAL SKILLS
IMMUNOLOGY
EXCEL
Additional Skills : CLINICAL RESEARCH
PROBLEM SOLVING
DATA SOURCES
DATA ANALYSIS
MARKETING ANALYSIS
PHARMD
DRUG DEVELOPMENT
MICROSOFT WORD
FILINGS
Minimum Degree Required : Professional (J.D., M.D., D.D.S. or Pharm. D.)
Thank you
vinaya@itengagements.com
