Director of Business Development
The primary objectives of the Director of Business Development are to build and maintain key customer relationships, identify new business opportunities, negotiate and close business contracts and maintain extensive knowledge of the current pharmaceutical industry.
Be a self-starter with sense of urgency and desire to succeed, who will take ownership of the business development function
- Have a track record of quantifiable achievements and possess a desire and ability to exceed expectations
- Be comfortable functioning as either a team leader or team member
- Maintain confident and credible oral communication skills
- Possess superior written communication skills with an unrelenting attention to detail and accuracy
- Cultivate well evolved win-win negotiation skills
- Maintain a solid comprehension of pharmaceutical industry, drug development process, with special emphasis on clinical development, FDA regulations, and ICH guidelines
- Be able to travel 30% to 50% of the time to visit pharmaceutical, biotechnology and consumer company prospects as well as attend meetings
- Have a Bachelor of Science plus five years of pharmaceutical or CRO experience. An advanced degree and experience in dermatology is preferred.
- Strong proficiency in Microsoft Word, Excel, PowerPoint
Associate Director, Quality Assurance
- A Bachelor’s degree and five to seven years of experience in clinical research quality assurance (all aspects) is required.
- Drug development lifecycle experience is highly desired.
- Strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, including database and eCRF validation procedures, eCTD Quality Assurance, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
- Must have the ability to proactively and indirectly manage and influence in a matrix environment within TI is required as is hands-on integration with functional processes.
- Some GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) experience is also highly desirable.
- Attention to detail as well as a crisp, clear and concise style in written and oral communications is required.
Senior Statistical Programmer
The Senior Statistical Programmer will play a lead role in supporting the statistical analysis and reporting of data from clinical and nonclinical studies.
- Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.
- Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
- Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
- Demonstrate extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
- NDA submission experience is a plus.
Regional Sr. Clinical Research Associate (Sr. CRA)
We are looking for a Senior CRA who would be home based in any major metropolitan area close to an airport hub. Our home office is located in San Diego, CA.
PRIMARY OBJECTIVE OF THE POSITION:
The primary objective of the Regional Senior Clinical Research Associate is to be responsible for the independent implementation and management of specific clinical trials. This individual will also have responsibilities for management and monitoring of specific investigative sites.
The ideal candidate will have:
- A Bachelor’s degree in a scientific discipline, RN or BSN degree, 4-year Life Science degree or equivalent and at least 5 years’ experience in clinical research or the medical field or a combination of education and experience.
- A knowledge/understanding of the principles of clinical research and drug development.
- Excellent written and oral communication skills.
- The ability to manage multiple priorities and attention to detail is critical.