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.
IQVIA Biotech delivers flexible, tailored, clinical and commercial solutions designed for biotech and biopharma companies. From planning, through trial design and delivery, and commercialization, IQVIA Biotech brings simplified operating procedures, specialized, therapeutically-aligned teams, and advanced data science to provide a more agile way for our customers to reach their drug development and commercialization milestones.
POSITION TITLE: Senior Director, Medical
REPORTS TO: VP, Medical IQVIA Biotech
Ideal candidate is a Board Certified/ Board Eligible Oncologist and/or Hematologist, Medical Doctor who will provide administrative leadership and management of assigned Medical Director/Medical Monitors staff as well as perform Medical Monitoring oversight.
The Senior Director, Medical provides management of assigned staff, and provides administrative leadership to the Medical Department by assisting the VP, Medical with delegated roles and responsibilities of managing the daily affairs of the department.
The Senior Director, Medical provides senior medical, clinical and scientific advisory expertise to IQVIA Biotech divisions.
In the role of Medical Monitor, the Senior Director, Medical 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 Director, Medical 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 Director, Medical serves as a medical expert throughout business development activities by developing and supporting the medical strategy.
Major duties of the Senior Director, Medical 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.
- Provides management and administrative support to Medical department activities
- Provides Line Management of assigned staff members including training, onboarding and mentoring assigned Medical department members and assigned external department providers (e.g.: NCR contractors, vendors, IQVIA staff members)
- Manages staff in accordance with IQVIA Biotech's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; review of assigned team members' work including Medical Monitoring Plans, appraising performance, mentoring and guiding professional development; addressing employee relations issues and resolving problems.
- Recommends course of action on management/human resources matters.
- Continually reviews assigned staff workload and creates volume projections to ensure adequate resources are available to meet deliverables timelines and quality requirements.
- Review sand provides updates of Medical department Quality Documents; e.g.; SOPs, WPs, training materials, job descriptions, CVs, bios.
- Contributes to the maintenance and creation of policies, processes, tools, and standards operating procedures for the department and provides oversight for their implementation.
- Leads implementation of goals and objectives of assigned staff members.
- Ensures Medical activities run according to GCP and operate with highest efficiency.
- Contributes to management level meetings within the IQVIA Biotech Medical department.
- Provides strategic inputs for Medical department resourcing process and outcomes, hiring targets and processes and onboarding and training standards.
- Provides Medical representation at Sponsor Audits with follow-up as necessary.
- Provides Medical input into CAPA resolution.
- Provides supervision of and input into the work of the Medical Operational bidders including review of RFPs, preparation of budgets, proposal text, staff assignments, bid defense coordination and preparation, protocol review assignments, etc.
- Provides input, guidance, and support to the Medical Department Business Officer.
- Provides input and guidance into the work of the Medical Data Review Director and team members.
Business Development Activities
- Works with Business Development to actively solicit new business for IQVIA Biotech, including assistance with marketing presentations and proposal development.
- Supports business development activities with proposal development and sales presentations.
- Provides medical and scientific input into new business proposals.
- Interacts with and supports IQVIA Biotech Feasibility in the development of proposals for new business, and in reassessing strategy for awarded studies.
- Participates in strategy discussions relating to specific proposals.
- Attends bid defenses in a managerial capacity representing IQVIA Biotech Medical, as required.
- Attends conferences and/or meetings in support of business development opportunities.
- Performs other special tasks or duties as requested by the VP of Medical, IQVIA Biotech or designee
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 multiple projects, each with specific requirements and/or shifting priorities.
- Excellent oral and written communications skills in English 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 Oncology and/or Hematology
Minimum 3-5 years of biopharmaceutical and/or Clinical Research Organization industry experience
This position is exempt from 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 firstname.lastname@example.org to arrange for such an accommodation.
Job ID: R1091593