The role of the Research Scientist is to support preclinical pharmacology efforts in the discovery and development of products in therapeutic areas of expertise. Assumes technical responsibility for all assigned nonclinical pharmacology activities pertaining to drug discovery, drug development, regulatory, and marketing commitments.
Duties and Responsibilities
1. Evaluate licensing opportunities for their scientific merit as well as safety.
2. Collaborate with Business Development and Scientific Assessment to conduct first-line assessments of licensing opportunities prior to conducting full due diligences.
3. Review and provide technical evaluation of pharmacology data related for in-licensing opportunities.
4. Oversee administrative and technical aspects of nonclinical studies conducted at contract laboratories.
5. Assist in the design and conduct of nonclinical studies to support regulatory submissions worldwide as well as non-standard study designs for label expansion and marketing.
6. Responsible for analysis and interpretation of nonclinical data and its potential relevance (safety/efficacy).
7. Provide support in the preparation of pharmacology sections of regulatory submissions, including Investigators Brochure, IND and NDA.
8. Participate in drug discovery programs with external collaborators. Assist in the design and conduct management of early stage nonclinical exploratory studies or pre-IND studies to support drug discovery and development.
9. Assist in activities related to the scientific communication plan in support of commercialization messaging.
10. Participate in problem solving in pharmacology issues.
11. Provide support to pharmacology representatives on project teams.
ADDITIONAL JOB RESPONSIBILITIES:
1. Assist in the publication of pharmacology results for marketed drugs and drugs in development
2. Conduct computerized literature searches for publications on assigned topics.
3. Participate in the review and authoring of SOPs as needed.
4. Contribute to Pharmacology process improvement initiatives as needed.
5. Participate in the interview and selection process for new Pharmacology staff as needed.
6. Provide input regarding study budgets
7. Perform other duties as assigned by management.
Education: Ph.D. or equivalent required.
Experience: Minimum of 3 years of relevant post-doctoral experience required. Pharmaceutical industry (drug discovery and development) experience preferred.
Knowledge, Skills, and Abilities:
Knowledge of drug discovery and development
Familiar with GLP and regulatory guidelines (FDA/ICH) regarding pharmaceutical development
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook, Microsoft Project, and Adobe Acrobat
Knowledge of budget planning systems and Documentum is a plus
Knowledge of database management is preferred
Must possess excellent skill/ability in the following:
Oral and Written communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships, Team Building and Influencing Others
Initiative and Accountability
Ability to perform internet and literature searches
Ability to work as a member of an interdisciplinary team
Ability to work independently on multiple projects under strict timelines
Ability to complete assigned projects with an objective and unbiased perspective