Wellesley Hills, Massachusetts

Job Description
The Executive Director Clinical Operations will manage the delivery model strategy and execution of an integrated clinical research hub through a matrix model. The leader will develop, manage, and lead a team of operational professionals. And be responsible for developing and implementing a clinical operational strategy and programs, focusing on clinical operations and program management. The Executive Director is expected to develop a skilled group of Clinical Research Staff to select and manage clinical study sites, participate in clinical trial study design and with the analysis of clinical trial data. The Executive Director will also develop efficient resourcing plans for all trials ensuring open headcount positions are identified and filled expeditiously with qualified individuals, recruit, motivate and manage all clinical operations staff including CTM to ensure professional development and training of a high performing team and be accountable for the Clinical Operations budget, forecasting and management of functional/trial budgets.

Additional responsibilities for the Executive Director include:
o Develop and maintain strong, positive collaborations with other functional leaders.
o Implement a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies and industry best practices.
o Develop and implement clinical monitoring training program to include GCP, monitoring and site management skills, and protocol-specific training (in collaboration with Medical Monitor).
o Establish quality processes within Clinical Operations that focus on data integrity and patient safety.(understand how a site operates)
o Lead responses to audits (site, internal file and process, and regulatory agencies)
o Develop and execute staffing plans to ensure adequate and appropriate monitoring of all trials
o Determine integrated delivery models that meet client (Diagnostic and Drug Development) needs today and tomorrow
o Determine the best way to approach and improve the client experience from a delivery standpoint
o Work closely with key stake holders in and across the BU’s and regions in Clinical Research to determine ways to improve integration, win and see rates, and repeat clients
o Recommend new, innovative approaches to create differentiated value with our new and existing client base leveraging the power of the combined
o Work closely as part of the leadership team to drive growth strategies, recommendations and implementation plans.
o Collaborates with Medical, Regulatory, Informatics, Statistics, Data Analytics and other leaders that contribute to the strategy, design, development and innovative solutions.
o Has a deep understanding of the industry, market and our clients and presents capabilities to clients. Collaborates closely with Strategy Leader; Designs and develops winning trial solutions that result in a growing, profitable portfolio of business
o Responsible for the evaluation of client expectations and experiences to detect opportunities to strengthen core capabilities and culture
o Provide recommendations and actions to address client concerns and monitor success of those recommendations in partnership with the commercial leader
o Monitor and assess ongoing client experiences across projects drug development and diagnostics
o Partners with key stake holders in developing high quality end-to-end business development strategies, including RFI response, proposal development, SME bid defense preparation and presentations
o Network and partner with executive leadership to define, drive and implement strategic initiatives, including cross business unit and functional integrated opportunities, to grow and expand the Clinical Research offerings
o Leads by Example in building and sustaining a scalable organization; creates a forward-looking culture of ownership and accountability; delegates for development and growth; identifies and sets up high performers for success; is self-aware and a learner.
o Effectively leads in a global, complex environment; sets clear expectations; coaches and mentors for success; consistently communicates and connects; fosters a continuous learning environment
o Attracts, selects, on-boards, develops and retains high performing talent; strengthens and deepens talent bench and succession
o Responsible for supporting portfolio growth and delivery
o Leads, provides and/or orchestrates commercial, operational, medical and scientific leadership and direction, leveraging expertise from other functions as required

Required Qualifications
Knowledge of:
• 10 or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), preferably including 10 or more years leading PII-PIV clinical trials in 1 or more Therapeutic Areas
• Program development and implementation
• Team set up and team development experience in the clinical research setting
• 10 or more years of global leadership experience, ideally in a complex, virtual and matrix environment leading large multi-functional teams
• Strategic level client relationships and business development experience
• Demonstrated vision, strategy and growth experience
• Financial acumen (P&L, budget, forecast, resources etc.)

COVID Requirements
CVS Health requires its Colleagues to be fully vaccinated against COVID-19 (including any booster shots if required), where allowable under the law, unless they are approved for a reasonable accommodation based on disability, medical condition, or religious belief that prevents them from being vaccinated.

If you are vaccinated, you are required to have received at least one COVID-19 shot prior to your first day of employment and to provide proof of your vaccination status within the first 10 days of your employment. For the two COVID-19 shot regimen, you will be required to provide proof of your second COVID-19 shot within the first 45 days of your employment. In some states and roles, you may be required to provide proof of full vaccination before you can begin to actively work. Failure to provide timely proof of your COVID-19 vaccination status will result in the termination of your employment with CVS Health.

If you are unable to be fully vaccinated due to disability, medical condition, or religious belief, you will be required to apply for a reasonable accommodation within the first 10 days of your employment in order to remain employed with CVS Health. As a part of this process, you will be required to provide information or documentation about the reason you cannot be vaccinated. In some states and roles, you may be required to have an approved reasonable accommodation before you can begin to actively work. If your request for an accommodation is not approved, then your employment may be terminated.

Preferred Qualifications
• Strong communication (both verbal and written) and language skills - ability to communicate effectively up and down in the organization
• Strong organizational/planning skills
• Ability to develop and apply creative solutions
• Experience in working cross-culturally and with virtual teams
• Multi-site clinical trial management experience
• 5+ years’ experience in working with and managing CROs or external vendors for the execution of clinical trials
• Project management experience
• Association of Clinical Research Professionals certification is preferred.

Education
Bachelor's Degree Required
Doctorate Preferred

Business Overview
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.


We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities. See Job Description

Wellesley Hills, Massachusetts

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