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Sr Director, Clinical Affairs at Illumina, Inc.

Posted in Management 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Foster City, California

Job Description:

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.

Position Summary:

Illumina is seeking an experienced Senior Director of Clinical Affairs. This person must be able to think strategically about the portfolio of products and clinical trials needed by the organization and work with functional leadership to ensure appropriate infrastructure and systems are in place to support the strategy. This role will lead a team of clinical operations professionals who oversee the implementation and execution of all sponsored clinical trials and will work with functional leadership to achieve program objectives within established timelines, budget, and to quality standards.

All About You

Responsibilities:


  • Provide strategic and technical guidance to ensure that clinical trials are properly defined, planned, and executed.

  • Oversee the management and execution of clinical trials, including meeting cost, quality, and timelines of multiple programs.

  • Ensure that high quality vendors are selected and effectively managed to achieve study timelines

  • Build a high performing, engaged team through strong management practices, setting clear goals, and managing conflicting priorities.

  • Facilitate cross functional and core team relationships with the team to enable achievement of goals.

  • Work with team to identify and continuously improve workflow standards that are compliant with regulatory guidelines, including internal operating procedures, oversight of study conduct, and any post market requirements necessary.

Requirements:


  • 12+ years of strong hands on experience executing clinical trials in both the USA and Europe required. Additional geographical areas preferred.

  • Minimum of 10 years managing clinical operations staff with demonstrably strong people management skills

  • Strong collaboration skills with a demonstrated ability to gather clinical expertise in different specialties and translate clinical practice to good clinical study design.

  • Experience designing and executing IVD clinical studies, including demonstrated success negotiating appropriate clinical trial design and acceptance criteria with FDA.

  • Must have experience in taking a large FDA trial from concept through submission to approval.

  • Significant biostats experience / understanding the intersection between clinical trial design, analytical studies, biostatistics, regulatory strategy and intended use

  • Strong written and verbal communication skills; demonstrated ability to organize and present scientific information (e.g., clinical study results) to internal and external audiences.

  • Requires approximately 30-40% travel, domestic and international

  • Able to confidently work with ambiguity.

  • Knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements

Education:

  • Bachelor’s degree in the life sciences or related field required, advanced degree preferred. (This role will require basic understanding of complex technical assays).

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at 858-255-5081. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf