Senior Director, Drug Safety

Lead pricing analytics for ACA markets.

Partner on market pricing and product strategy.

Lead safety sciences and surveillance.

Set strategies for signal detection.

Drive site start-up activities and ensure readiness.

Execute planning and delivery of site start-up strategy.

Lead global Quality Systems and GxP compliance.

Oversee and manage QMS operations.

Lead Safety and Pharmacovigilance team.

Ensure compliance with global regulations.

Implement SOPs for clinical trials.

Lead programming activities for high-quality submissions.

Oversee regulatory compliance for medical devices.

Manage submissions pipeline for OXOS products.

The Sr. Clinical Research Manager will lead and manage clinical studies in a fully remote capacity, ensuring alignment with business goals and regulatory compliance. With a focus on developing study plans and authoring essential clinical documents, this role is pivotal in driving the success of pharmaceutical and wellness initiatives. Candidates should have extensive experience in clinical research and a strong understanding of GCP and regulatory requirements, making this an exciting opportunity for seasoned professionals in the field.

Coordinate with stakeholders for study objectives.

Join Apogee as the Medical Director of Pharmacovigilance, where you will ensure the safety of our pipeline and maintain high data quality standards. You will lead crucial safety initiatives, collaborate with regulatory teams, and contribute to the lifecycle management of our products. This role offers the chance to impact patient safety significantly within a dynamic and supportive environment, complete with competitive compensation and opportunities for professional growth.

Ensure compliance with global regulatory requirements.

The Director of Clinical Science will lead the clinical evidence strategy for Software as a Medical Device (SaMD) at a rapidly growing health tech company. This role involves translating innovative concepts into clinical endpoints, guiding regulatory submissions, and overseeing validation studies. With over a decade of experience required, this position offers an exciting opportunity to shape the future of digital health while building and mentoring a strong clinical science team.

Translate concepts into clinical endpoints.

Join BlueRock as a Senior Medical Director in Clinical Safety, where you will lead safety efforts across our clinical trial portfolio. This role involves assessing serious adverse events, managing safety signal detection, and ensuring compliance with global safety regulations. With a focus on innovative therapies, this position offers a unique opportunity to impact patient safety in the rapidly evolving field of cell and gene therapy.

Conduct causality determinations for SAEs.

The Clinical Trial Manager/Senior Clinical Trial Manager role offers an exciting opportunity to lead and oversee clinical studies in a dynamic environment. You will be the primary point of contact for clients, ensuring effective communication and project execution. Your responsibilities will include developing critical study documents and managing site feasibility processes. With over 7 years of clinical research experience, you will play a pivotal role in advancing clinical trials while collaborating with regulatory teams. This position not only offers a chance to make an impact in the pharmaceutical field but also provides a comprehensive benefits package.

Serve as primary contact for clients.