Senior Medical Director, Clinical Development Ophthalmology

We are a clinical stage biopharmaceutical focused in multiple therapeutic areas, including ophthalmology, and looking to grow the team with a Senior Medical Director-VP level Clinical Development! Please contact me for further details.

Competitive benefits package
Opportunity for growth
Flexible schedule
Strong pipeline

Job Details

We are seeking a dynamic and experienced individual to join our team as a full time Senior Medical Director, Clinical Development. This role is a unique opportunity to make a significant impact in a fast-paced, innovative, and growing scientific industry. You will be responsible for leading clinical development activities for our pipeline of novel therapeutics. This is a strategic role that will require you to work closely with cross-functional teams, including research, regulatory, and commercial teams, to ensure the successful development of our innovative products.

Responsibilities

As a Senior Medical Director, Clinical Development, you will:

1. Lead the design, execution, and interpretation of clinical trials for our pipeline products, ensuring all activities are compliant with GCP guidelines.

2. Develop and implement clinical development strategies for early and late-stage drug development programs, with a focus on rare diseases and ophthalmology.

3. Oversee the preparation of clinical protocols, investigator brochures, IND, and NDA submissions, ensuring all documents are scientifically sound and meet regulatory requirements.

4. Collaborate with cross-functional teams to ensure alignment of clinical development strategies with business objectives.

5. Provide medical and scientific expertise to internal teams, advisory boards, and key opinion leaders.

6. Monitor and interpret data from ongoing and completed studies, and recommend modifications to future studies as necessary.

7. Stay current with latest developments in biotechnology and clinical research, and adapt strategies as needed.

Qualifications

The ideal candidate will have:

1. A medical degree with a specialty in ophthalmology or a related field.

2. A minimum of 12 years of experience in clinical development in the biotechnology or pharmaceutical space/.

3. Proven experience in designing and managing clinical trials, including early and late-stage drug development.

4. Strong knowledge of GCP, IND, and NDA requirements, and experience in preparing regulatory documents.

5. Experience in rare disease drug development and ophthalmology is highly desirable.

6. Strong leadership skills, with the ability to influence and work effectively with cross-functional teams.

7. Excellent analytical, problem-solving, and decision-making skills.

8. Outstanding communication and presentation skills, with the ability to clearly convey complex scientific information to a variety of audiences.

We are looking for a driven and passionate individual who is ready to contribute to our mission of advancing innovative therapies for patients. If you are looking to make a significant impact in a fast-paced, innovative environment, we would love to hear from you.