Job Overview

The Senior Medical Director provides medical and scientific support to clinical research programs, study teams and investigators.  The Senior Medical Director also provides review, advice, and leadership for potentially or actually awarded clinical research programs.
The Senior Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. 

Essential Functions

Functions as project team member

• Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting
• Ensures medical activities run according to GCP and operate with highest efficiency
• Establishes and maintains a network of medical/scientific consultants, etc.
• Supervises and manages Medical Director activities

• Clinical Activities:

• Interacts with clients regarding drug development programs, study design and protocol
• Reviews and provides input for protocol development.  Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints.  Interacts in team approach to develop statistical and data management sections of the protocol.  Reviews the final protocol for clinical, safety and efficacy variables.
• Provides project team training on protocol and/or therapeutic areas
• Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation.  Aids in review and final selection.
• Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations
• Presents protocol and/or safety reporting information at investigator meetings
• Develops project medical monitoring plans as requested 
• Interact with appropriate FDA officials concerning safety and other study related issues, as requested

DSMB/Adjudication Committee Activities:

• May assist sponsor in choosing committee members
• May serve as a non-voting member to convene and organize proceedings
• May develop operating guidelines in conjunction with committee members and submits these to sponsor for review
• May determine data flow with sponsor to ensure reporting accuracy
• Can ensure DSMB feedback is given to sites for IRBs
• * All DSMB activities are usually managed by the IQVIA Oversight Management Group and not the IQVIA medical monitor
• • Business Development Activities
• Work with Business Development to actively solicit new business for IQVIA, including assistance with marketing presentations and proposal development
• Supports business development activities with proposal development and sales presentations
• Participates in feasibility discussions relating to specific project proposals

Special Projects:

• Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
• Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities
• Participate in a variety of team quality improvement efforts as necessary
• Perform other related duties as assigned or requested by the Chief Medical Officer

Qualifications

• Minimum 3-5 years of biopharmaceutical industry experience or academic experience in clinical research and drug development
• Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus

• Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment
• Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
• Excellent oral and written communications skills as well as interpersonal skills are essential
• Cardiology.

•  Current or prior license to practice medicine; board certification/eligibility ideal
•  Board Certified / Board Eligible: Cardiology

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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

New York City Pay Transparency : The salary range for this role is $236,700 - $319,900.The actual salary will vary based on factors like candidate qualifications and competencies.