CAREERS AT VYERA
Be a Part of the Vyera Vision
At Vyera, you can build a career that makes a valuable difference. We are proud to work with some of the most talented colleagues across the science, business and pharmaceutical industries. Together, we can vastly improve the lives of people who live with rare and serious diseases while driving a path forward in innovative medicinal advancements. Our team is seeking dedicated individuals to join our growing organization and contribute to finding solutions for some of our patients’ most critical challenges. Join us in implementing Vyera’s vision of patients living longer and healthier lives. Apply to one of our open positions today!
We Welcome Applications from All Qualified Candidates
We're looking for people who are passionate about identifying, creating and bringing to market therapies that can change the lives of underserved patients. We believe diversity is essential to creating a truly innovative and dynamic environment. To ensure that we support an atmosphere where innovative thinking can thrive, we look for applicants from a range of backgrounds and with a variety of work and life experiences.
If you’re interested in a career at Vyera, take a look at our current openings to find the best fit for your talents. Click any title to see a relevant job description and to submit your application for that position. If you have already submitted or saved an application, click My Account to retrieve it. For general applications, please send your resume to firstname.lastname@example.org.
Vyera Is an Equal Opportunity Employer
Vyera Pharmaceuticals, LLC is an Equal Opportunity employer. We are committed to the hiring, advancement and fair treatment of all individuals and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected status as designated by federal, state, or local law. For more information about your rights as an applicant: EEO is the Law and EEO is the Law Supplement.
|Title:||Clinical Development Medical Director|
|Department:||Clinical Development & Clinical Operations|
|Number of Openings:||1|
The Clinical Development Medical Director will provide clinical leadership and medical strategic input for all clinical deliverables, including pharmacovigilance, for both clinical development and post market surveillance. The ideal candidate will possess experience and a proven track record of advancing and completing clinical trials successfully. A background in Infectious and/or Rare diseases is preferred, but experience in other related specialties may be considered. The successful candidate will bring a robust knowledge of protocol design, experience working with Scientific Committees and Advisory Panels, recruitment of clinical sites and analysis/interpretation of clinical data for regulatory body review (US and EU).
MAJOR ACTIVITIES AND RESPONSIBILITIES
- Responsible for clinical development strategies including Phase I through III, product safety reporting responsibilities, interactions with regulatory bodies, and interactions with corporate partner(s).
- Leads and oversees the strategic definition and tactical development of clinical study programs, including protocol writing, interpretation of clinical data, and literature reviews.
- Serves as the primary clinical resource for questions and reports related to pharmacovigilance activities, for both investigational and commercial products.
- Ensures that all clinical studies are in keeping with approved timelines, with potential obstacles identified and solutions implemented to avoid delays in clinical study execution.
- Serve as Medical Monitor and Vyera’s medical representative to multiple vendors and collaborators: CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials.
- Ensures that clinical studies are conducted in accordance with applicable regulatory requirements and guidelines.
- In conjunction with Regulatory Affairs, ensures the timely preparation of quality clinical study documents to be submitted to the FDA and other health authorities in support of regulatory applications e.g. INDs, NDAs etc.
- Ensures the timely preparation of presentations and publications reporting results of clinical studies to internal and external audiences.
- Collaborates with colleagues in the discovery research and preclinical development line functions to move product candidates into clinical investigations.
- May represent the Clinical Research line function on multidisciplinary project teams.
- Works with marketing to evaluate product candidates and determine product indications, as appropriate.
- MD with 5+ years of experience in direct investigational drug development with Phase I-III, at the sponsor level.
- 3 years of contribution to, and accomplished in, clinical data interpretation and presentation to regulatory bodies and as well as scientific meetings and conferences.
- Experience in a related therapeutic area such as Infectious Disease, Rare Disease or other related specialty.
- Thorough knowledge of ICH guidelines and GCP requirements related to clinical research.
- A working knowledge of biostatistics as relevant to the design and analysis of clinical studies, is preferred.
- Team player with executive presence and demeanor coupled with excellent written and verbal communication skills as well as outstanding analytical abilities.
- Comfortable working both internally and externally with technical and medical experts in providing input into future drug development strategies.
- Experience presenting clinical programs to health authorities e.g. FDA, EMA is preferred.
- Independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style
- Travel will be required, up to 60%
Notice to Recruiters
Vyera's Human Resources Department manages the recruitment and employment process for the Company, and all candidates must be presented through this Department. If your agency wishes to establish a relationship with Vyera, you must work directly with the Human Resources Department. Contacting our hiring managers or employees directly is not appropriate. For more details, please email email@example.com.
For the protection of all parties involved, Vyera will only accept resumes from recruiters if an executed agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Vyera from recruiters do not constitute any type of relationship between the recruiter and Vyera and do not obligate the Company to pay fees should we hire from those resumes.