Assoc Director, Program Operations Leader Clinical Experimental Science Operations
- Regeneron Pharmaceuticals, Inc.
- Tarrytown, New York
- Start date
- Feb 3, 2023
- Clinical, Clinical Research, Manufacturing & Production
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
The Associate Director (AD), Clinical Experimental Science Operations (CES Ops) is responsible for leadership within the group and supports strategic management of clinical research studies across the early development experimental science portfolio (e.g. biomarker development studies, platform validation studies, technology/innovation pilots, sample collection studies) within Clinical Trial Management & Global Monitoring (CTM&GM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct is in accordance with Regeneron Standard Operating Procedures (SOPs), CES Ops mentorship's and ICH/GCP, as applicable. Additionally, there are responsibilities for ownership and leadership of CES Ops continuous improvement and Strategic Imperatives workstreams, with a focus on ensuring cross functional alignment and process improvement that supports the guiding principles and vision of the group. The CES Ops portfolio is dynamic in nature, study types include, but are not limited to, less sophisticated data transfer agreements, retrospective sample/data acquisition studies to more sophisticated prospective studies including sample/data acquisition, biomarker/technology/method validation, genotypic/phenotypic call back studies, and challenge/screening studies. In rare instances the more sophisticated studies may require out-sourcing to Clinical Research Organizations (CROs); the balance of direct leadership versus oversight will vary accordingly. This role will interface heavily with Basic Research/Discovery as well as with clinical site staff, predominately at academic institutions. This role will be responsible for direct line management including responsibility for staff recruitment, development, coaching, mentoring and performance management.
A typical day in this role might look like...
- Chips in to the overall success of CES Ops portfolio delivery and may serve as a point of contact for leadership and oversight for the CES Ops team
- Chips in to the direction, strategy and interpersonal development for the CES Ops team
- Provides strategic decision making and integrates all operational considerations for studies to ensure goals are attainable prior to implementation
- Maintains an overview of clinical study status and issues and proactively communicates' progress, risks, issues or changes that may impact quality, timelines and/or budget; provides updates to partners, including senior
- Is responsible for clinical study budgets: ensures review, presentation and approval of study budget and leads the budget and raises concerns to Head CES Ops, as appropriate
- Ensures timely delivery of quality operational results and accountable for ensuring consistency of process and approaches across the portfolio
- Reviews key metrics and Key Performance Indicators (KPIs) across studies within CES portfolio to identify trends and build mitigation strategies
- Provides innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges
- Chips in to resource forecasting and resource allocation for assigned portfolio
- Responsible for direct supervision of staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
- May require up to 25% travel
This role might be for you if.....
- Bachelor’s degree and minimum of 10 years relevant industry experience.
- Experience in non-interventional research or similar projects/research
- Experience in operational execution, process evaluation and development related to exploratory/experimental research study conduct
- Working knowledge of regulations and requirements for exploratory/experimental research studies
- Analytical skills with a data driven approach to planning, executing, and problem solving
- Effective interpersonal skills via verbal, written and presentation abilities
- Strong project management, cross-functional team leadership and interpersonal skills
- A solid understanding of GCP and ICH
Salary Range (annually)$165,900.00 - $270,700.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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