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Manager, Clinical Insights & Observational Research

Requisition ID:  34833
Date:  May 6, 2021
Location: 

Bangalore, Karnataka, IN

Department:  R&D

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

 

The Manager, R&D, Clinical Insights & Observational Research is a team leadership role responsible for developing and executing clinical research in human and animal models both internally and in partnership with CRO’s and Principle Investigators within West’s network of collaborators.  This role applies in-depth knowledge to drive continued hypothesis testing through observational human studies and interventional experimentation in animal models.  The successful candidate will work collaboratively with thought leaders in novel technologies to create clinical research strategies that achieve the organization’s goals.  The candidate will help cultivate a vision for the future of healthcare in the context of possibilities presented by dynamic bio-monitoring, leveraging deep expertise to impact the patient experience of generations of products to come. 

 

Essential Duties and Responsibilities:

• Lead all aspects of observational clinical research and animal study execution including, protocol development, study coordination, scheduling, implementation, data analysis/interpretation, and report writing.
• Coordinate and lead the team through journal publications and scientific conference presentations and internal market development activities
• Lead in appropriate interpretation and dissemination of all evidence generated, based on Evidence Dissemination Strategies, including Clinical Study Reports, abstracts, manuscripts, etc
• Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc;
• Develop strategy leveraging internal resources, third parties, suppliers, hospitals, PI’s, and contract research organizations to deliver evidence on new product platforms and digital solutions
• Create and maintain project plans, proactively manage technical and project risk, drive key decisions and tradeoffs to ensure successful product technology embodiments
• Translate highly technical results into easily understood recommendations that will influence senior stakeholders. Provide clear communication, proactively communicate plans and progress while escalating risks, or needs to remove roadblocks for the team.
• Impact West’s achievement of its long-term strategy objectives by setting the direction of the clinical research team in the pursuit of new technology and novel product platforms
• Coach a driven team of clinical researchers and scientists, ensuring they have the skills, tools and opportunities needed continuously raise the bar on team performance.
• Set team priorities, allocate resources, and development methodology to achieve department business objectives
• Attracts, recruits, develops and builds capabilities. Inspires, coaches, trains, motivates and evaluates team members to enable their capabilities and accomplish the department’s priorities.
• Perform other duties as assigned

 

Required Qualifications:

• A Bachelor’s degree in Biological Science or related discipline with a minimum of 8 years experience, or an MS with 5-8 years of experience, or a PhD with 5+ years of related scientific / technical experience, including leadership / management role within Clinical Research is required.
• Minimum of 5 years experience of direct clinical and preclinical research experience
• Previous experience in a Clinical Trial Manager role
• Professional certification (clinical research, laboratory) preferred. If certification is not in place, class work/ course work in Good Clinical Practices is required.
• Thorough understanding of clinical research science and processes along with a broad understanding of product development processes, team dynamics, related healthcare market environment, and clinical trends.
• Ability to provide strategic and scientific clinical research input across the organization’s platform development initiatives.
• Proven track record in delivering clinical programs within clinical or pre-clinical research setting, on time, within budget and in compliance to SOPs and regulations is required.
• Comprehensive understanding of clinical trial regulations across multiple regions is required especially observational study design. 
• Ability to lead teams to deliver critical milestones, including complex projects is preferred.
• Ability to collaborate across different functional areas within clinical research and development to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc).
• Statistical / Analytical capabilities and familiarity with the use of statistical software.
• Must be able to trouble-shoot and problem solve to support successful animal study execution.
• Strong Communication (oral/written) to included strong presentation skills, including ability to communicate in small and large settings and with senior level management, regulatory agencies and physicians

 

Preferred Qualifications
• Experience in diagnostic device clinical research
• Experience authoring peer reviewed research
• Proven track record of successfully designing, planning and executing medium to large scale clinical studies, to include creative study design, resource planning and budgeting, contingency planning and timely execution
• Demonstrated Ability to deal with ambiguity – ready and able to effectively and efficiently change plans quickly to meet the changing needs of the business and projects
• Track record of recruiting exceptional talent, building high performing teams to include managing, mentoring and motivating employees
• In depth understanding of healthcare, device, and biotechnology industry issues
• Minimum of 5 years of people management experience

 

Physical and Travel Requirements
• Willingness to travel both domestically and internationally up to 20%
• Work in an office/home office environment.  At times required sit or stand for extended periods of time.
• Ability to effectively communicate and comprehend complex ideas and concepts.
• Use written and oral communication skills.
• Read and interpret data, information and documents.
• Must maintain the ability to work well with others in a variety of situations. Strong ability to build and maintain solid work relationships.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems.

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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