IQVIA Senior Medical Director, Biopharma (Home-Based) - IQVIA Biotech in Baltimore, Maryland
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
POSITION TITLE: (Senior) Medical Director - BioPharma (Cardiology, Endocrinology, Neurology, or Rheumatology )
REPORTS TO: VP, Medical IQVIA Biotech
The (Senior) Medical Director provides senior medical, clinical and scientific advisory expertise to IQVIA Biotech divisions.
The (Senior) Medical Director provides medical oversight as the first line of support for clinical trials to which he/she is assigned as medical monitor. As such, the (Senior) Medical Director provides medical and scientific oversight of all aspects of Medical involvement on proposed and/or assigned studies including support of pre-award/proposal activities and support to study teams and investigators of awarded studies.
The (Senior) Medical Director serves as a medical expert throughout business development activities by developing and supporting the medical strategy by providing review, advice, and leadership for potentially or actually awarded clinical research programs. Additionally, the (Senior) Medical Director provides medical and scientific support to clinical research programs, study teams and investigators.
The (Senior) Medical Director is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of (Senior) Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference.
Major duties of the (Senior) Medical Director are outlined below:
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Participates in pre-award activities to support the acquisition of new business including working with Feasibility team members.
Provides medical or scientific input into new business proposals.
Attends and presents at bid defenses.
Provides expert medical guidance for protocol or program development.
Serves as Medical Monitor for awarded studies.
Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection as requested.
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/Skype presentations as requested.
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 medically focused regulatory guidance and input re: regulatory submissions.
Provides guidance to study team members and sponsors on the medical and scientific aspects of assigned projects.
Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues for assigned studies.
Serves as first point of escalation for the project team and sponsor for medically related matters of awarded work.
Attends Kick-Off meetings and internal team and client meetings for assigned studies.
Provides project team training on protocol and/or therapeutic areas.
Develops project medical monitoring plans
Attends and presents at Investigator Meetings for assigned studies.
Provides medical and scientific input to 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 as requested.
Serves as Medical Safety Reviewer and/or Medical Data Reviewer for assigned studies as requested.
Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites for assigned studies.
Safety Monitoring and SAE Reporting Activities:
Works with the IQVIA Biotech or vendor Safety Management Department to provide medical review and case assessment of SAEs including review and edits of SAE narratives and safety queries, follow-up on outstanding safety queries, and interacting with sponsors and sites to discuss safety issues with site as needed.
Reviews IND/SUSAR Safety Reports (per sponsor preference), provide updates to Investigator Brochures, and annual IND reports with sponsor data as requested.
In consultation with the sponsor, follows procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind) as requested.
Interacts with appropriate FDA officials concerning safety and other study related issues, as requested.
Provides input into and guidance and review of work of the Medical Data Review Director and team members.
Provides medical input into the development of eCRFs and edit check specifications for medical accuracy as requested.
Reviews medical coding of adverse events, medical history and con meds for medical accuracy and consistency as requested.
Reviews adverse events, laboratory data and concomitant medications and other sponsor requested data points for accuracy, coherence, consistency, and trends as requested.
Provides medical review of the data analysis plan.
Reviews safety fields at case freeze for reconciliation as requested.
Works with the safety and data groups to reconcile SAE events as requested.
Reviews data tables, listings, and figures as requested.
Reviews and/or writes portions of final clinical study report as requested.
KNOWLEDGE, SKILLS, AND ABILITIES:
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
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Ability to travel domestically and internationally as required
Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
Current or prior license to practice medicine;
Board certification/eligibility in one of the following medical specialties would be ideal: (Cardiology, Endocrinology, Neurology, or Rheumatology )
Minimum 3-5 years of biopharmaceutical and/or Clinical Research Organization industry experience
Extensive academic experience in clinical research and drug development conducting clinical trials
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com_ to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
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