- Lead the development of strategic scientific and medical input into clinical research programs and individual clinical trials
- Collaborate with Kedrion Global Clinical Research teams to drive scientific content of protocols, clinical study reports, clinical investigator brochures, briefing books, orphan drug applications and other documents
- In conjunction with Contract Research Organization (CRO) personnel, lead medical oversight of clinical research programs, including medical monitoring, safety evaluations, protocol deviations, and other required activities
- Develop and maintain bank of external key opinion leaders and consultants related to Kedrion projects
- Oversee and drive strategic statistical input into clinical research programs
- Prepare and deliver scientific and medical presentations for key opinion leaders, regulatory authorities, and internal groups
- Lead production of primary manuscript publications from completed clinical trials
- Lead development and strategy team focused on cutting edge scientific and medical input
- Maintain current knowledge of strategic trial design and data generation to include registries and real-world data generation in support of registration programs
- Represent Kedrion at key external scientific congresses, advisory boards, and other meetings
- Advanced degree in medical, pharmacy, or relevant scientific field (MD, PharmD, PhD). Health sciences related degree preferred
- Proven experience (15 years) in industry clinical research trial design and execution
- Demonstrated experience interacting with global regulatory agencies (FDA, EMA, MHRA, etc.)
- Preference to candidates with Rare Disease or IG experience
- Excellent written and verbal communication skills
- Documented personnel management experience
- Familiarity with regulatory guidelines (e.g., Good Clinical Practice, ICH, FDA, EMA guidelines, etc.)
- Attention to detail, strong organizational skills, and the ability to manage multiple projects and deadlines effectively
- Collaborative and adaptable team leader who can work effectively in a fast-paced, cross-functional environment
- Based in the US, preference to Eastern or Central US Time Zones
- Willingness/ability to travel domestically and internationally when required. Candidate should reside near a major airport.
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Vice President, Global Clinical Development and Strategy - Fort Lee, United States - Kedrion Biopharma, Inc.
Description
Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries.Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.
The
Vice President of Global Clinical Development and Strategy will report into an Executive Committee Member and can be a remote position, preference to Eastern or Central US Time Zones, and located near a major airport.
Main responsibilities include:
Requirements/Skill Set:
_- Medical, vision and dental insurance_
_- Life and AD&D insurance_
_- Paid holidays_
_- PTO accrual_
_- and much more_
_Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have_
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.
_Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications._
_All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.
