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Associate Director Clinical Operations Biotech Jobs in Wisconsin

Socket.dev

WI · On-site

$180 - $250/hr

... biotechnology sponsors, helping bring innovative therapies to patients through cutting-edge ... This individual will collaborate closely with clinical operations, product, scientific, and ...

Wisconsin

iSchool Associate Director

Madison, WI · On-site

We are seeking an Associate Director to work closely with the Director and Department Administrator ... Evaluates operations and outcomes to ensure alignment with organizational goals * Formulates ...

YDU JC Air Cond & Ref Inc.- Dubai

$141 - $237/hr

About the Role We are seeking a highly strategic and organized Associate Director Product Operations to oversee complex programs across Johnson Controls' OpenBlue product portfolio, including but not ...

Foundation Medicine

WI · On-site

$192 - $236/hr

Provide regular support and education regarding disease state awareness and FMI clinical data to ... biotech, pharmaceutical, or other life sciences company * Oncology experience Preferred ...

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Associate Director, Clinical Scientist - Ophthalmology

Initial Therapeutics, Inc.

Oregon, WI • On-site

$154.50 - $249.95/hr

Other

Posted 8 days ago

Job description

This role is reporting to the Chief Medical Officer and is remote.

Primary responsibilities include, but are not limited to, the following:

Individual Responsibilities
  • Contribute in collaboration with a cross‑functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio.
  • Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) on all clinical trial documents including Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with ICH/GCP standards/Federal and local regulations and company SOPs.
  • Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans.
  • Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials.
  • Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre‑IND, IND, End‑of‑Phase II, NDA, MAAs and other regulatory meetings and regulatory filings as required.
  • Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program.
  • Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation.
  • Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations.
  • Assist with study milestones and study metrics in collaboration with clinical operations.
  • Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines.
Primary skills and knowledge required include, but are not limited to the following:
  • A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required.
  • Experience in ophthalmology and familiarity with drug/device combination products.
  • Experience with all phases of clinical drug development including regulatory submissions.
  • Ability to survey and interpret scientific literature related to the assigned portfolio of products.
  • Strong communication, organizational and interpersonal skills.
  • Successful work experience in a matrix team environment with cross functional teams.
  • Independent decision‑making and analytical skills.
Level of Education Required:

Advanced degree in life science/clinical/medical field, PhD or PharmD.

Number of Years of Experience in the Function and in the Industry:

Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level.

Compensation Principles

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including education, training, experience, market conditions, criticality of the role and internal equity.

Salary Range

$154,500 – $249,947 USD

Equal Opportunity Employer

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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