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Director/Sr. Director, Clinical Affairs
Osanni Bio, Inc. San Francisco, CA
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$154k-250k (estimate)
Full Time 1 Month Ago
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Osanni Bio, Inc. is Hiring a Director/Sr. Director, Clinical Affairs Near San Francisco, CA

Osanni is Designed for Sight. We are creative & agile innovators, passionate about developing breakthroughs to save eyesight.

At Osanni we are creating a uniquely different biotech company with the talent and unconventional thinking to deliver therapies to prevent and reverse blindness caused by retinal diseases.

We focus where others aren’t. Retinal diseases are multi-factorial, so we are using our energy and ingenuity to navigate our own original path to address these sight-threatening conditions. Our approach to drug development brings creativity to science through design thinking. We are committed to tackling the toughest challenges and creating fundamentally different approaches to save vision. Our belief is that if we hold patients’ eyesight and physician practices as are our North Star, it will enhance our purpose, decision making, and our impact.

We are building a highly skilled and passionate team that truly enjoys the challenge of conquering the agility course of drug development and entrepreneurship. People are our greatest asset in achieving our ambitious mission at Osanni.

Introduction to the Role:

The candidate will join an exciting start-up with a nimble and fast-paced team that is pioneering therapeutics to cure blindness. This role will help lead clinical and design clinical studies for new biotechnology products. This role is critical in ensuring the successful planning, execution, and regulatory approval of clinical trials, as well as the ultimate commercialization of biotech products.

We are based in the vibrant incubator located in San Francisco, CA.

Key Responsibilities:

  • Support the development of strategies that integrate discovery research with clinical approaches to proof-of-concept in appropriate patient populations
  • Provides recommendations and insights on study feasibilities based on knowledge of the field and through direct contacts with key opinion leaders, potential investigators, patient advocacy groups, and advisory boards
  • Provide scientific expertise for selection of investigator and vendors
  • Train colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
  • Oversight of clinical study execution ensuring successful study completion
  • Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
  • Review, query, and analyze clinical trial data
  • Interpret, and present clinical trial data both internally and externally

Required Skills and Background:

  • Advanced scientific degree preferred
  • Minimum of 15 years experience in clinical development, including involvement in all stages of clinical trials, ideally having taken at least one study through from start to finish in a clinical scientist role
  • Ophthalmology experience highly preferred
  • Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing
  • Thorough understanding of the drug development process including experience leading and contributing to the development of key clinical documents (e.g., protocols, ICF, CRF, IB, SAP, CSR, DSUR) and ability to review and interpret clinical data
  • High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
  • Experience in managing budgets and resources is highly preferred.
  • Collaborative, self-starting spirit able to work both independently and as a part of a team
  • Ability to multi-task and work efficiently in an environment with changing priorities
  • Some travel required - up to 25% (including some international travel)

The expected base pay range for this position is $225,000 - $300,000 plus bonus and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to be a part of designing the future of sight-saving therapeutics, then we are excited to hear from you!

Job Summary

JOB TYPE

Full Time

SALARY

$154k-250k (estimate)

POST DATE

03/11/2024

EXPIRATION DATE

04/06/2024

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