Total 2 Director/C-Level Science / R&D / Research job vacancies in Boston, Lincolnshire

Job Description

Vertex Pharmaceuticals is seeking a Health Economics & Outcomes Research (HEOR) Associate Director - pain to join the North America HEOR team.  This role will support and develop key HEOR tactics to ensure successful commercialization of novel NaV 1.8 inhibitors for acute and chronic pain in the United States (US) and Canada. This person will work in a highly cross-functional matrix team environment to ensure a seamless alignment of HEOR projects within the broader market access, policy, and medical strategy.  This person is expected to exhibit a strong sense of urgency to achieve corporate objectives while maintaining the highest ethical, regulatory and scientific standards.  This position reports to the Director, Pain launch lead, North America HEOR.

Key Responsibilities

• Own development of tactics for innovative HEOR solutions and deliverables that directly support optimal patient access to in the US and Canada throughout the product’s lifecycle  
• Drive the development of external customer-facing value demonstration tools in accordance with regulatory standards, in close collaboration with formal review bodies (e.g., Commercial Review Committee; Medical Review Committee) while supporting appropriate field teams (e.g., field HEOR, payer team)
• Work closely with global HEOR team to provide the US and Canadian perspective to evidence generation activities and to ensure timely and effective translation of HEOR studies for field use
• Directly engage with external customers (e.g., payer accounts) to deliver HEOR presentations when appropriate/requested
• Own execution of local HEOR studies in partnership with customers (e.g., payers, integrated health systems)

Qualifications

• Advanced degree (e.g. PhD, MD, MPH, or PharmD) in a scientific discipline.  
• Typically requires 8+ years of experience, with substantial background in HEOR, or the equivalent combination of education and experience. US launch experience in pain and/or other primary market experience is preferred.
• Robust understanding of the 2018 FDA Payor Guidance to payer communication in the US is strongly preferred.
• Understanding of the HTA process and methodology; hands-on experience with HTA dossier submission and review is preferred.
• A track record of peer-reviewed publications demonstrating experience in COAs, observational research, and/or health economic modeling.
• Strong communication skills, both verbal and written, including the ability to effectively present to both internal and external audiences
• Results oriented and excellent analytic and project management skills. 
• A strong sense of urgency and commitment to patients

This is a hybrid eligible role requiring at least 3 days on-site in Boston office.

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Company Information

Position: Director of Research Operations and Clinical Programs, Emergency Medicine      

Location: Boston, MA

Schedule: 40 hours per week

ABOUT BMC:

At Boston Medical Center (BMC), our diverse staff works together for one goal — to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by our respect for our patients and our commitment to ensure everyone who comes through our doors has a positive experience.

You’ll find a supportive work environment at BMC, with rich opportunities throughout your career for training, development, and growth and where you’ll have the tools you need to take charge of your own practice environment.  

POSITION SUMMARY:

Under the general direction of the Chair of Emergency Medicine, and Vice Chair of Research, plans, directs, coordinates, and implements all federal, industry sponsored, and unfunded research projects that take place in the Department of Emergency Medicine at BMC.

Oversees all targets for budgets with funding entities including local, state, federal agencies, and other external funding agencies for patient and related research programs. The PI bears overall responsibilities for proposal development, but works closely with the Director of Research Operations to assure all compliance requirements are met. Responsible to interface with funding agencies, administration of funded programs and fiscal oversight.

JOB RESPONSIBILITIES

• Directs and coordinates all study related activities. Manages research grants, budgets, and payroll.
• Assures all BMC, City, State and Federal guidelines are followed pertaining to the clinical and ethical responsibilities of all studies conducted in the Department
• Maintains compliance with FDA and/or any other regulatory commission standards. Assure that all PIs and study staff have appropriate certification in the Protection of Human Research Subjects
•  Establishes objectives with all staff members on the research team; determine standards of performance; evaluates subordinates’ performance and ensures that individual staff members are meeting objectives.
• Works directly with faculty and PIs and guides them through appropriate documentation and approvals with the IRB, modifications, amendments, continuing review and close out reports.
• Facilitates all interdepartmental study activities (Laboratory Medicine, Investigational Pharmacy, Radiology, Trauma Surgery, Boston EMS, and any other collaborating department for individual protocols).
• Responsible for notifying and training ED nursing leadership and staff for any study that may potentially impact ED workflow or require clinician/provider assistance.
• Responsible for training all study related activities to research staff.
• Effectively manages and controls purchase and distribution of supplies and equipment for all ongoing studies.
• Responsible for overseeing study staff accurately schedule clinical procedures, and follow up visits when appropriate. Responsible for initial and ongoing training of all research staff members
• Ensure staff competency in all clinical and data platforms (Epic, QPath, Info Ed, Infor, Clin Cards, Velos, WebDCU, RedCAP, Qualtrix etc.).
• Oversees clinical research databases, including statistical and other data collection, analysis, and reporting for grant-funded contracts and for other clinical care and clinical research programs.
• Works directly with Research data analyst and Biostatistician from conception of idea, through completion of study and publication.

• Responsible for the effective human resource management within the research Section of Emergency Medicine
  • Works with the HR Business Partner or appropriate supervisor/Director to resolve any salary, benefit or human resources related problems.
  • Effectively works with Human Resources at BMC to resolve issues in a timely fashion.
  • Works directly with Human Resources to post new positions, hire, discipline, and terminate employees as needed.
• Organizes faculty, residents, and research study teams to submit abstracts, edit presentations, and write and submit scientific papers for publication; participates as author.

The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job.  The above is not intended to represent an exhaustive list of accountable duties and responsibilities required

JOB REQUIREMENTS

EDUCATION:

• Advanced degree (Masters or above) required; degree related to clinical health care or public health administration preferred

CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:

• Certified in Human Subjects Training
• Certified in shipping of Biohazardous materials
• Certified in Good Clinical Practice Guidelines for research

EXPERIENCE:

• Requires at least ten years of clinical healthcare administration and management experience.
• Experience with proposal preparation and team leadership skills.

KNOWLEDGE AND SKILLS:

• Exceptional communication skills both written and verbal
• Knowledge of federal grants/research and programs/grants administration policies and practices.
• Ability to anticipate objections and plan appropriate responses; ability to perform and lead effectively in stressful situations and solve problems as they occur.
• Requires excellent communication and interpersonal skills to interact effectively with a multi-layered interdisciplinary team and outside contacts.
• Experience and knowledge of networking and clinical site operations, scientific operations and clinical management
• Ability to prioritize and manage multiple projects simultaneously with demonstrated ability to complete projects successfully on time and within budget.
• Proficiency with computer tools including word processing, spreadsheets and presentation applications.

JOB BENEFITS:

• Competitive pay
• Tuition reimbursement and tuition remission programs
• Highly subsidized medical, dental, and vision insurance options
• Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base.

ABOUT THE DEPARTMENT:

As the primary teaching hospital for Boston University Chobanian & Avedisian School of Medicine and BU schools of public health and dentistry, intellectual rigor shapes our inquiries. Our research is led by a belief that skin color, zip code, and financial circumstances shouldn’t dictate health.

Boston Medical Center is an Equal Opportunity/Affirmative Action Employer. If you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail to Talentacquisition@bmc.org or call 617-638-8582 to let us know the nature of your request.

Equal Opportunity Employer/Disabled/Veterans