Job Title: Principal Clinical Research Scientist
Job Description: Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, womenÃ¢??s health (obstetrics/gynecology), orthopedics and Oncology. FerringÃ¢??s US operations employ approximately 900 people.
People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.
Rebiotix, a late-stage biotechnology company part of the Ferring Pharmaceutical Group, is focused on commercializing the worldÃ¢??s first Microbiota Restoration Therapy. By harnessing the power of the human microbiome, Rebiotix aspires to change the way challenging gastrointestinal diseases are treated. Our goal is to improve the lives of patients and reduce the cost of care associated with some of the most debilitating disorders suffered by patients worldwide. We are a passionate team of scientists, engineers and clinical researchers motivated by the opportunity to blaze new trails and create new technologies for todayÃ¢??s medical field, looking for like-minded individuals to add to our growing team.
Summary: This role is responsible for leading or supporting assigned study-level activities for one or more clinical studies (Phase 1-4); for development and/or review of clinical study documents; data analysis, interpretation, and presentation; and to provide scientific support for clinical development planning, study design/execution, and data monitoring to ensure successful implementation of high-quality clinical research programs for Rebiotix products.
- Maintains knowledge as to developments and trends in applicable treatment landscape, including current treatment strategies and new therapeutic developments.
- Designs and authors clinical study protocols that are scientifically and statistically sound, align with the Rebiotix strategic plan, and meet regulatory requirements.
- Synthesizes literature, competitive information, and results to evaluate new therapeutic areas with potential indications and propose study designs.
- Designs clinical development plans, as directed by Clinical Management.
- Provides content development and editorial assistance for scientific publications, professional meetings, and/or post-marketing study activities, including abstracts, manuscripts and presentations.
- Development of training material for internal team about current treatment and therapeutic developments.
- Assists in the review and interpretation of clinical data during study conduct and following database lock.
- Contributes to the development of publication strategies for clinical development programs.
- Bachelor's degree in Life Sciences, Computer Sciences, Mathematics, or health-related field.
Prefer MD, PharmD, or PhD.
- 8 or more years of progressive clinical research experience in biotechnology or pharmaceutical industry. MD, PharmD, or PhD will count for 3 years.
- Strong interpersonal skills and ability to collaborate with and influence physicians, regulators, and stakeholders.
- Excellent verbal and written communication skills. Interpersonal and organizational skills are a must.
- Detail-oriented with excellent writing, communication and presentation skills.
- Well versed and current in GCP, ICH, FDA and other relevant regulations and guidances that govern clinical study conduct.Exceptional communication skills, both oral and written.
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
If you need assistance during the application process due to a disability, please email email@example.com