Key Role in Clinical Research and Safety
This is a highly sought-after role for individuals with expertise in clinical trials management within the pharmaceutical industry. As a Senior Director/Executive Director - Clinical Research Physician, you will be responsible for overseeing medical strategy and safety oversight for multiple assets across various therapeutic areas.
The ideal candidate should have experience in conducting development activities in compliance with all local laws and regulations and ICH guidelines. A strong knowledge of GVP and experience in case management, signal detection, benefit:risk assessment are also essential. Additionally, the ability to grasp complex scientific concepts quickly and apply them effectively to development programs is crucial.
In this role, you will work closely with a multidisciplinary team to construct and execute a sound clinical development plan, develop a PK and biomarker strategy, and integrate early phase data to select an appropriate dose regimen for proof-of-concept studies. You will also provide medical leadership for clinical plans, study documents, and risk/benefit assessments. Effective communication skills and the ability to represent the organization to key external stakeholders are required. The role also involves serving as a single point of accountability for medical safety matters across the portfolio and collaborating with internal experts and external thought leaders to maintain awareness of current trends and projections for clinical research.
The successful candidate will bring new technologies and innovation to Chorus protocols as appropriate and serve as a member of the Protocol Review Committee (PRC). They will also conduct due diligence on compounds that are potentially entering the Chorus portfolio to assess feasibility and fit. A strong computer skillset and experience presenting data to varied stakeholders are necessary. This is an ideal opportunity for a drug safety physician seeking to expand their clinical research/clinical development experience.