Director, Clinical Research

San Diego, California

  Biostatistics

270000

Permanent

Our client is an exciting pharmaceutical company that are committed to creating groundbreaking therapies for those affected by rare endocrine diseases. This organization is actively shaping the future landscape of endocrine healthcare, leading the way from pioneering discoveries to patient-centric clinical development.

They are hiring a Director of Clinical Research to play a crucial role in developing and overseeing the company’s endocrinology portfolio within a dynamic, multi-disciplinary development team. The successful candidate will be responsible for formulating the clinical development plan, designing and implementing clinical trials, and supervising programs within designated therapeutic areas.

Responsibilities:

  • As the Director of Clinical Research, you will collaborate with the executive team to develop and obtain approval for the Clinical Development Plan (CDP).

  • You will lead the design, planning and execution of clinical trials in alignment with the approved CDP.

  • Author clinical protocols, amendments and related documents, ensuring strict adherence to regulatory requirements.

  • Collaborate with cross-functional teams to establish project development timelines and provide regular updates.

  • Conduct medical monitoring for clinical studies in collaboration with CRO medical monitors.

  • Ensure strict adherence to Good Clinical Practice (GCP) and regulatory requirements throughout the course of clinical trials.

  • Participate in data analyses, contribute to regulatory documents, and lead advisory boards related to trials.

  • Oversee and project-manage clinical programs, ensuring the timely execution and completion of trials.

Skillset:

  • Master’s degree required, with a minimum of 10 years of clinical research experience in either industry or academia. 

  • A minimum of 8 years of experience in a supervisory or leadership role.

  • Endocrinology subspecialty board certification is desirable.

  • Comprehensive knowledge of clinical medicine, clinical pharmacology, and related disciplines.

  • Excellent knowledge of FDA and EMA regulations, Good Clinical Practice, ICH guidelines, and the intricacies of clinical drug development.

  • Experience in interacting with regulatory agencies such as the FDA and/or EMA.

  • Strong leadership skills coupled with a strategic mindset, enabling effective functioning in a fast-paced, science-driven environment.

Benefits:

  • Salary: $200k – 275k DOE

  • Stock options

  • 401k match

  • Health Insurance plans

If this sounds like the role for you, apply now in the link below or email your resume directly to michaels@alldus.com for consideration.

42189

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