Senior Clinical Development Manager
4 weeks ago
**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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