at Grifols Shared Services North America, Inc in Conway, Arkansas, United States
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
The overall responsibility of the SVP, Drug Development is to provide strategic, visionary leadership and tactical expertise throughout the clinical development process in a highly collaborative and global environment.
+ Drive an innovative field of multiple therapeutic areas for broad disorders; creative thinker and implementer.
+ Work across therapeutic modalities including plasma fractions, small molecules and medical devices, unconstrained by the specifics, open to the best approaches.
+ Be responsible for the creation and execution of clinical development plans, protocols, data analyses, clinical study reports, and other related clinical documents that are derived from the company’s deep scientific understanding of the aging plasma proteome
+ Serve as the external representative of Grifols’ clinical program in interactions with development partners, CROs, the FDA, and clinical consultants.
+ Develop strong, collaborative networks with other internal and external functional leaders including translational medicine, clinical operations and pharmacovigilance, to enable efficient project planning and execution
+ Lead studies/programs at all stages of clinical development including, but not limited to, first in man studies and randomized, global trials
+ Collaborate in the preparation of INDs, BLAs/NDAs, and Investigator Brochures.
+ Author, contribute and/or review clinical sections of regulatory documents, external communications, etc.
+ Collaborate (as needed) with consultants (such as statistician and other experts) to assure successful study design methodology, statistical analysis plans, data management, trial results, etc.
+ Author and execute clinical development plans (CDP) for product candidates.
+ Lead clinical advisory boards and investigator meetings
+ Be current in clinical trials methodology and responsible for the interpretation of overall clinical study outcomes
+ Provide clinical input and collaboration in business development activities, including due diligence and partnering meetings.
+ Actively engage and participate in cross functional collaborative teams such as (but not limited to) the iTags.
+ Lead strategic development and due diligence of potential new indications and clinical therapies, based on scientific results generated from the Company’s preclinical research
+ Report to the Chief Scientific Innovation and manage an internal clinical development team
A Doctor of Medicine (MD) is required
Minimum 10 years’ experience in design, execution and evaluation of clinical trials and new product submission documents, either in the specialty pharmaceutical or biopharmaceutical industry is essential.
Knowledge, Skills & Abilities:
+ In depth understanding of pharmaceutical regulatory requirements and their impact on development of clinical trials and NDAs.
+ Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory requirements
+ Must have experience developing and editing FDA briefing books and attending meetings
+ Must have extensive experience overseeing CROs, central laboratories, and other clinical study vendors with a track record of bringing studies to completion on time and within budget.
+ Effective leadership skills and proven ability to foster team productivity and cohesiveness. Demonstrated experience managing and mentoring clinical team members, and overseeing team of external consultants
+ A collaborative team player with a personal style that is collegial, flexible and forward- thinking, with a “work smarter” approach
+ Enjoys problem solving and possesses the ability to address issues arising from a medical, regulatory and clinical trial perspective
+ Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must
+ Able to engage in work-related travel when required
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran’s status or any other classification protected by applicable State/Federal laws.
Learn more about Grifols (http://www.grifols.com/es/web/international/home)
Req ID: 502810
Type: Regular Full-Time
Job Category: Research & Development