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Director, Medical Affairs - Urology Pelvic Health Job

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Date: Jan 6, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MN-Minnetonka

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

***Open to the Director, Medical Affairs position being a remote role

 

About this role:

The Director of Medical Affairs, Urology Pevlic Health reports directly to the VP of Clinical Sciences and oversees the clinical strategy for the Core Stone and BPH franchises and serves as the global Clinical Lead for the business.  This includes determining key clinical data gaps and developing plans to fill them, overseeing clinical trial design, reviewing ISR and other study requests from external investigators, leveraging existing product clinical data for developing appropriate product positioning for patients and physicians, maintaining effective and strong working relationships with global KOLs, and helping develop marketing materials. 

 

The Director of Medical Affairs sits on the Clinical Sciences Leadership Team and serves as a business partner to Marketing, R&D, HEMA, Regulatory, Product Risk/Risk Management, and Corporate leadership, aligning with the overarching business strategies and ensuring carefully designed and well-conducted clinical studies support identified business priorities and are conducted in compliance with BSCI procedures.  This position has global responsibility and leverages Boston Scientific global medical affairs staff and / or contract clinical resources to implement clinical projects in compliance with local laws and regulatory requirements. They will serve as the scientific and clinical expert within their assigned therapeutic area(s), representing current clinical practice and opinions, and serve as the primary point-of-contact contact with leading clinical researchers in the field of study.

 

Your responsibilities will include:

  • Develop the clinical strategies for assigned therapeutic area(s) in collaboration with business partners.
  • Direct the evidence planning for clinical trials including, end point definition and ascertainment, data analysis, ensuring that end point data will satisfy publication, regulatory and payer requirements
  • Identify unmet clinical needs – in the area of procedures, products, or other services
  • Leverage existing product clinical data for developing appropriate product positioning for patients and physicians
  • Responsible for clinical elements of overall business strategy
  • Collaborate with HEMA to provide clinical support for effective reimbursement strategies
  • Provide key clinical data and guidance for the development of impactful marketing material
  • Develop and manage effective working relationships with global KOLs
  • Respond to unsolicited physician requests for off label clinical information
  • Provide clinical guidance for development of physician training content
  • Evaluate business development opportunities and external ideas for studies, new products, procedure enhancements
  • Coordinate clinical response/input for NCEP’s, PIR’s, and CAPA’s  
  • Manage clinical aspects (providing clinical information, ISR Guidance, etc.) of KOL interactions for the business unit 
  • Lead the recommendation and selection process of all pre and post clinical research studies within the therapy area(s)*
  • Build strategic partnerships to achieve departmental and organizational objectives.  Interact with internal and external leaders, regulatory agencies, customers, vendors and/or suppliers.
  • Communicate at all levels in the organization to ensure that therapeutic area(s) strategic plans are clearly understood and the vision, values, and philosophy of the company are maintained.
  • Define, assist and prioritize with clinical investigators appropriate clinical research papers, abstracts, and presentations within the therapy area(s)
  • Provide clinical input for the development of training content where necessary
  • Coordinate resources with other groups within the clinical department to ensure resource allocations that maximize global revenue forecasting and meet business objectives within budget.
  • Work with other members of the BSC Clinical Community to develop and/or identify new work processes that will have broad applicability throughout the company; contributes ideas for improving work processes and achieving organizational goals; investigates and solves problems that impact work processes and personnel in multiple units or departments.
  • Must be able to travel at least 20% of schedule, both domestic and international.
  • Develop plans to enhance enrollment, promote collaborations with KOLs, and ensure compliant clinical sites
  • Provide clinical assessments for MARC materials review

 

What we’re looking for in you:

Minimum Qualifications

  • 10+ years of management experience in drug, medical device, or epidemiological multi-center IDE or IND studies, or equivalent. 
  • Proven leader and has demonstrated the ability to achieve results through leading a team of professionals; 8+ years’ experience leading, coaching and developing a team of clinical professionals, including demonstration of inclusive leadership behaviors
  • In-depth knowledge of IDE/IND, PMA/NDA, 510(k) or equivalent and GCP procedures.  Working knowledge of GCI procedures and international processes, understanding of MDD, MDR requirements, policies, procedures
  • Technical and medical aptitude required in achieving an expert level of knowledge of the therapeutic area(s) disease states and the device/technology utilized in treatment and diagnosis of associated conditions
  • Demonstrated ability to drive cross-functional efforts and manage clinical project teams and oversight a project portfolio with consistent achievement of deliverables. In-depth knowledge of study design and development of study processes to support the design
  • Demonstrated ability and/or experience in physician/patient contact.
  • Experience working on and leading cross-functional teams
  • Demonstrated track record of working independently, performing accurate assessment and planning, providing leadership, utilizing effective problem solving and creative thinking techniques, consistently meeting deadlines and achieving deliverables, and demonstrated professionalism, collaboration and follow through.

Preferred Qualifications

  • Experience to include primary responsibility in designing, executing a full clinical study; preferably a regulated study successfully
  • Multi-disciplinary experience including marketing
  • Demonstrated track record of working independently, performing accurate assessment and planning, providing leadership, utilizing effective problem solving and creative thinking techniques, consistently meeting deadlines and achieving deliverables, and demonstrated professionalism and follow through.
  • Proven leader and has demonstrated the ability to achieve results through leading a team of professionals.

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 472262

 


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