Senior Clinical Development Manager

4 weeks ago


Cambridge, Massachusetts, United States ONO PHARMA USA Full time

**Clinical Development Opportunity**

We are seeking a highly skilled Senior Clinical Development Manager to join our team at ONO PHARMA USA. This is a unique opportunity to lead the development of clinical drug programs and portfolios, working closely with Project Leaders and Medical Directors.

  • Develop and implement clinical development strategies to determine the efficacy and safety of candidate drug products.
  • Contribute to the development of clinical development plans, ensuring alignment with strategic objectives and regulatory reporting requirements.
  • Lead the development of essential documents, such as clinical protocols, TLFs, and clinical study reports.

**Key Responsibilities**

  • Collaborate with cross-functional teams to ensure clinical data collection and documentation meet regulatory requirements.
  • Monitor and evaluate clinical data to inform development and design of clinical drug programs and portfolios.
  • Develop and maintain relationships with external investigators and key opinion leaders.

**Requirements**

  • Bachelor's degree in Life Sciences or equivalent; advanced degree preferred.
  • 5-7 years of pharmaceutical industry experience in clinical drug/biologics development and regulatory processes.
  • Experience across Phase I-III drug development projects, with a focus on product development in therapeutic areas aligned with ONO's pipeline.

**Technical Skills**

  • Knowledge of ICH, GCP, FDA regulations, and other guidelines.
  • Strong data analysis and problem-solving skills.

**Language/Interpersonal Skills**

  • Excellent communication and presentation skills.
  • Ability to interact with internal team members and external partners to inform on study objectives and endpoints.

**Other**

  • Strong organizational skills to ensure data collection and documentation meet regulatory requirements.
  • Ability to travel up to 30% of the time.


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