Regular Full-TimeJob Code
Questcor Pharmaceuticals, Inc. is a specialty biopharmaceutical company which provides products for patients with serious, difficult-to-treat autoimmune and inflammatory disorders. We support research in a number of rare conditions, including in treatment-resistant patient populations, in which there is significant need for improved therapeutic options. Questcor was awarded Orange County Register’s #1 Best Large Company of 2012 and Forbes’ Magazine’s #1 Best Small Company award in 2011, #7 in 2012, and #1 in 2013.
We are currently seeking an Director, Clinical Research.Responsibilities:
- Executes the strategy of clinical research programs as determined by the R&D Senior Management Team, with leadership in designing studies and in the conduct and management of clinical studies;
- Provides clinical research expertise, especially study design and data interpretation;
- Reads and develops clinical protocols and all associated materials given the scientific literature, clinical practice, and changes in the regulatory environment that impact study design and interpretation;
- Interprets clinical study results and writes corresponding reports;
- Contributes to research programs based on an understanding of the pathophysiology of disease, mechanism of action of drugs, and the relevance of targeted pathways in defined patient populations;
- Leads or participates on R&D Development Teams which are responsible for the design, and conduct of all clinical research programs;
- Collaborates with members of other groups in the company (e.g., Regulatory Affairs, Clinical Operations, Safety/Pharmacovigilance, Medical Affairs, Pharmaceutical Development, Sales/Marketing) to achieve corporate goals;
- Provides support in defining the development strategy, with the R&D Senior Management team, for products in development (e.g., pipeline products, LCM programs);
- Works collaboratively with Project Management and Clinical Operations in the design and conduct of clinical research studies;
- Participates in interactions with regulatory agencies;
- Develops and reviews FDA documents (e.g., briefing documents, IND, NDA) and study related documents (e.g., Investigator Brochure, CRFs, protocol, CSRs, etc.);
- Works with sales and marketing to provide key review and feedback for new indications and promotional materials;
- Presents information and respond to questions from project teams, external vendors, KOLs, and customers;
- Ensures that quality, regulatory-compliant development projects are conducted on time and within budget, meeting corporate and R&D goals.
To perform this job successfully, the individual must be able to perform each essential duty independently. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Able to work in the confines of our processes yet help to improve them as needed. Able to provide high quality work and achieve R&D goals.Qualifications:
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Internet software, E-mail.
- M.D. with a minimum of 5 years’ experience at a pharmaceutical company in clinical trial design and the interpretation of results from Phase 2 and/or Phase 3 studies, or relevant clinical;
or translational research experience and clinical expertise acquired in an academic setting;
- Experience writing, reviewing and editing clinical protocols and study reports;
- Ability to exercise judgment and determine appropriate action;
- Ability to manage deadlines;
- Ability to work independently;
- Proven ability to provide solutions to a variety of technical problems of moderate scope and difficult complexity;
- Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors, KOLs, and customers.
- Fellowship training or scientific expertise in immunology, inflammation or related field preferred;
- Experience on product development teams;
- Experience interacting with the FDA on INDs, NDAs, and development programs;
- Working knowledge of guidelines and FDA regulations for prospective clinical trials;
- Experience and demonstrated success in working with KOLs, PIs and CROs.
Questcor Pharmaceuticals Inc. offers employees a Total Rewards package, which includes competitive base pay and bonus opportunities, excellent benefits, an outstanding work environment and the chance to grow, both financially and professionally.
For more information, you may view our website at http://www.questcor.com/careers/company-benefits.
Questcor is an Equal Opportunity Employer.