About The Company
Our client, a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs for oncology treatments, is currently seeking a Medical Director/Senior Medical Director to join their team.
The Medical Director/Senior Medical Director will act as the primary lead for clinical trials (Phase I – III), working with cross-functional study teams on clinical trial strategy, design and execution. Key responsibilities include:
- Acting as primary Medical Monitor, monitoring the safety of enrolled subjects on assigned trials.
- Participating in the development of Study Protocols, IBs, Clinical Development Plans and other key study documents with minimal guidance.
- Participating in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Providing scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
- Acts as liaison between Clinical Development and other internal groups (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
- MD, DO or equivalent non-US medical degree required
- 5+ years clinical research experience in an academic or industrial setting required, Oncology experience highly desired
- Experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
- Experience managing clinical trials and/or clinical development program(s)
- Excellent oral and written communication skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
- Global clinical research experience and experience interacting with regulatory authorities
If you are interested in this position, please send your resume to firstname.lastname@example.orgHelp