Sr Director, Clinical Trials

Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Plymouth

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
The Senior Director of Clinical Trials, Interventional Oncology and Embolization (IO&E) is responsible for defining, executing, and overall program management of our global clinical trial program, covering all clinical development responsibilities and deliverables. This role will lead the IO&E clinical trial team and involves integrating design, feasibility, and operational planning to ensure clinical trial development programs are aligned with corporate and strategic goals.  This position will help create and execute the strategy for the clinical development operations function.  This leadership position requires the highest level of expertise in strategic thinking, collaboration, talent selection and development, operations management, problem solving, and decision making.
 
Your responsibilities will include:

• Directing your team in the design, planning, execution, and reporting of all company-sponsored clinical trials and evidence-generating programs worldwide.

• Ensuring clinical studies within the therapeutic area are executed as per plan, within timelines and budget while maintaining high quality

• Developing operational strategies to optimize clinical trial execution

• Actively participating in strategic planning within the organization, translating strategic decisions into clinical operational plans and delivery.

• Providing leadership guidance, direction, and oversight to Contract Resource Organization (CRO) and external vendors involved in clinical trial programs

• Establishing and maintaining excellent relationships with clinical trial investigators, Key Opinion Leaders, and other external stakeholders.  This will include assisting in the identification and selection of clinical trial investigators.

• As a member of the IO&E LT, advising and contributing to the development of global business strategy while providing status updates on progress of clinical trial programs

• Collaborating and building partnerships cross functionally through business units, corporate clinical teams, and geographies to achieve organizational objectives, capitalizing on operational synergies to improve efficiency and compliance, and incorporating innovative and creative approaches to the generation of clinical evidence

• Providing leadership that promotes motivation and empowerment of others in order to accomplish individual, team, and organizational objectives of the function.  

• Assisting in the recruitment, training, and development of the clinical team to ensure efficient operation of the function while building the infrastructure to support advanced clinical trials

• Ensuring compliance with company policies, procedures, and the applicable regulatory requirements

• Representing clinical team in discussions with Health Authorities

• Domestic and international travel  

 
Required qualifications:

• 15+ years of clinical trial operations, strategy, and management in the oncology field. 

• 8+ years of experience in building and leading a high performing team

• Proven experience in developing and executing operational strategy, and demonstrated performance in the execution of clinical trial programs across numerous phases of development

• Experience designing, planning and managing clinical trials/research studies

• Experience in building teams with trial execution expertise

• Proven experience and knowledge of clinical operations, project management tools and processes

• Financial acumen and budget management 

• Extensive experience with managing CROs, other clinical vendors, and outsourced operations

• Ability to leverage knowledge and apply new ways of looking at problems, processes, or solutions to generate and champion new ideas, approaches, and initiatives

• Skilled and experienced in organizational change

• Expert level knowledge of ICH/GCP guidelines and their role in clinical trials

 
Preferred qualifications:

• Advanced degree in medical or biological sciences or field associated with clinical research

• First in Human (FIH), early feasibility or Phase 2-4 and solid tumor experience

• Demonstrated ability to:

  • Maintain a strategic perspective, and make decisions and align activities with business vision and purpose

  • Look for and champion efficient and effective methods/processes of delivering clinical development focusing on key performance metrics centered on activities, outcomes, efficiencies, cost, and quality

  • Effectively collaborate and influence a broad range of global stakeholders

  • Respond flexibly and positively under conditions of uncertainty or change

  • Lead courageously by confronting problems directly and taking decisive action

  • Assess, coach, and develop organizational talent, and foster a diverse workplace that enables all team members to contribute to their full potential

Requisition ID: 561073

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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