Clinical Development Lead-Biotech Startup
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Salary: $350,000 - $425,000 per year
A bit about us:
We are a small biotech located in the greater Boston area. We are hiring a clinical development lead with a strong background in Ophthalmology or Dermatology, and we ideally want someone with strong Phase II experience. Please apply if you fit the criteria below!
Why join us?
Competitive compensation
Stock options
Flexible schedule
Established team with strong funding
Job Details
Job Details:
Our fast-growing biotech startup is seeking a Clinical Development Lead/Sr. Director Clinical Development. The individual will be responsible for managing, planning, and executing clinical development programs in the fields of dermatology, immunology or ophthalmology.
Responsibilities:
1. Lead the planning, implementation, and management of clinical development programs, ensuring that all activities are compliant with Google Cloud Platform.
2. Collaborate with cross-functional teams to ensure clinical development programs align with the overall company objectives.
3. Develop and maintain relationships with clinical investigators and key opinion leaders in dermatology and ophthalmology.
4. Guide and oversee the preparation and submission of regulatory documents, including INDs, NDAs, BLAs, to the FDA and other regulatory authorities.
5. Utilize knowledge of RNAi technology to drive the development and advancement of clinical programs.
6. Monitor clinical trials to ensure data quality and integrity, identify and address any issues or deviations.
7. Collaborate with the medical writing team to prepare clinical study reports, publications, and presentations.
8. Stay abreast of the latest developments in the scientific industry, with a particular focus on dermatology and ophthalmology.
Qualifications:
1. MD degree or equivalent with a specialization in dermatology. immunology or ophthalmology, as well as strong phase II experience.
2. A minimum of 3 years of clinical development experience in the biotech/pharma industry, preferably within a startup environment.
3. Extensive knowledge of Google Cloud Platform, FDA regulations, and the BLA process.
4. Familiarity with RNAi technology and its application in clinical development.
5. Proven track record of successful clinical program management and execution.
6. Excellent leadership and team management skills.
7. Strong communication and interpersonal skills, with the ability to build and maintain relationships with key stakeholders.
8. Ability to work in a fast-paced, dynamic startup environment, managing multiple projects simultaneously.
9. Strong problem-solving skills and the ability to make decisions under pressure.
10. Willingness to stay updated on the latest trends and developments in the scientific industry, particularly in dermatology and ophthalmology.
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Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 91113390
- Position Id: 120102267
- Posted 1 day ago
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