Clinical Development Lead

Jobot; Boston (MA); On-site; USD 325,000 - 375,000; Full time

Benefits offered by this job

Competitive compensation

Stock options

Flexible schedule

Established team with strong funding

Job summary

A biotech startup in Boston is looking for a Sr. Director Clinical Development with expertise in ophthalmology or dermatology. The role involves managing clinical programs, ensuring compliance with regulations, and collaborating with teams. Candidates should have an MD and 5+ years of experience, alongside strong leadership and communication skills. This position offers a competitive salary and benefits in a fast-paced environment.

Qualifications

• 5+ years of clinical development experience in biotech/pharma, preferably in a startup.
• Extensive knowledge of GCP, FDA regulations, and the BLA process.
• Familiarity with RNAi technology in clinical development.

Responsibilities

• Lead planning and management of clinical development programs.
• Collaborate with cross-functional teams to align clinical programs.
• Prepare and submit regulatory documents to the FDA.
• Monitor clinical trials for data quality and address issues.

Skills

Clinical development experience

Leadership skills

Communication skills

Problem-solving skills

Education

MD degree or equivalent

Job description

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NEW Sr. Director Clinical Development - Ophthalmology / Dermatology - Biotech Startup

Salary: $325,000 - $375,000 per year

This job is hosted by: Audrey Block

Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.

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. Please apply if you fit the criteria below!

Why join us

• Competitive compensation
• Stock options
• Flexible schedule
• Established team with strong funding

Job Details

Our fast-growing biotech startup is seeking a Sr. Director Clinical Development. The individual will be responsible for managing, planning, and executing clinical development programs in the fields of dermatology or ophthalmology.

Responsibilities

1. Lead the planning, implementation, and management of clinical development programs, ensuring that all activities are compliant with GCP.
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 or ophthalmology.
2. A minimum of 5 years of clinical development experience in the biotech/pharma industry, preferably within a startup environment.
3. Extensive knowledge of GCP, 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.

Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.

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