ASSOCIATE DIRECTOR CLINICAL RESEARCH

ASSOCIATE DIRECTOR CLINICAL RESEARCH

私たちがしていること

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Who We Are

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Role reports to:

Dir Translational Sciences Self Care

Location:

North America, United States, New Jersey, Summit

勤務地:

ハイブリッド

あなたがすること

The Associate Director, Clinical Science will lead clinical strategy for new product development and clinical programs across all phases of product development. This role is responsible for designing, executing, and reporting clinical studies, ensuring regulatory compliance, and representing clinical strategies during health authority interactions. The position requires building strong relationships with scientific leaders, overseeing clinical evaluation reports and post-market studies, and supporting safety and labeling activities. As a key leader, you will manage a team and collaborate cross-functionally to deliver innovative self-care solutions.

Key Responsibilities

•  Serves as clinical strategy lead for NPD and clinical programs in all phases of product development which includes planning, design, execution and reporting of clinical studies for assigned need states.

• Responsible for representing clinical strategies during health authority interactions and negotiations in support of NPD for their assigned need states.

• Assures timely and quality completion of investigator brochures, study protocols, clinical study reports, and any documents needed for regulatory filing as well as timely and accurate publication of completed research.

• Develops and maintains credible relationships with scientific leaders and medical/clinical consultants.

• Responsible for clinical evaluation reports for devices in development and for post-market clinical follow up studies for in-market devices in their assigned need state.

• Support activities as needed including, but not limited to, Safety Management Teams, Core Data Sheet/Labeling Working Group activities, review of periodic safety reports, ingredient/product issue management and benefit/risk challenges.

• Manage direct and indirect reports.

What We Are Looking For

• An advanced degree (e.g., PhD or PharmD or MD) is strongly preferred.

• Experience in mapping out and leading full clinical development programs for regulatory submission strongly preferred.

• Demonstrated ability to understand the business context and work closely with commercial business partners in the development of selfcare products.

• Experience in a people/team management capacity, and ability to work cross functionally across geographies.

• Ability to manage multiple projects and mentor team members

• Excellent verbal and written communication skills.

それは何ですか

$166,600.00 - $235,200.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

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