Participates in process improvement activities across company
Contributes or may lead the development of company policies and processes involving medical, safety and therapeutics
Identifies potential areas for improvement in departmental processes – partners with global clinical operations to develop new, and enhance existing, client relationships
Provides leadership and presents medical/scientific capabilities to clients as a participant of a proposal team
Leverages known, and builds new, relationships with investigators/sites to perform site/investigator feasibility and support optimal recruiting and conduct of trials
Presents or serves on panels to represent the company at conferences and scientific meetings
Supports and participates in the recruitment process for department positions
May provide mentoring to and be responsible for the oversight, career development and evaluation of clinical research physicians, associate medical directors and medical directors
Involved in the assignment of projects and specific duties to direct reports
Responsible for administration and/or delegation of activities of his/her direct reports
Provides leadership to junior staff within the ta
Leads initiatives that impact the ta and involves physicians within the ta and across the ta
May contribute to vision and strategy/direction for the ta
According to the scope of work, serves as global lead project physician or as program level physician across multiple indications for a company –
Develops training modules and materials as required, and provides training in disease areas and protocol specific requirements across the company
Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines
Oversight and review of escalated issues/gaps and proposals for process improvement and initiatives
Performs medical data review; reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed
Provides input, review and revision of protocols, case report forms, training materials, project specific tools, analysis plans design, clinical trial reports and new drug applications
Prepares materials for investigator meetings – actively participates in investigator meetings
Provides medical/scientific expertise to project teams
Responsible for medical and safety monitoring on assigned projects
Interacts with inter-departmental and external consultants as appropriate
Participates in feasibility discussions relating to specific project proposals
Participates in project risk assessment activities
Provides out of hours medical cover as required
Assists when needed with data safety monitoring board activities
Provides clinical and medical expertise to other labcorp departments
Provides evaluation and oversight of medical data review performed by central medical data reviewers
Reviews and/or assists with medical monitoring scope of work/hours and budget discussions as required for new proposals and assigned studies
Provides oversight of project and medical management to ensure timelines and quality of medical deliverables and assigns physician resources as required
Maintains subject matter expertise through ongoing continuing medical education (cme) or clinical work as well as attendance at relevant conference/meetings
Provides subject matter and drug development expertise and is a key contributor to the medical strategy and execution of the study/program for the client
Contributes to the scientific strategic leadership for a given ta
Performs other duties as required by the department
Minimum required:
Md degree md preferred: – relevant sub specialty fellowship training and history of board certification which can – be a substitute for the board certification specialization, as appropriate
The medical director based in india needs to cover different therapeutic areasA broader experience in general medicine / internal medicine is required as a minimumFurther sub specializations (respiratory, gastroenterology, hematology) are appreciated.
Experience:
Candidates with 10+ years of experience in a cro/pharma setting with strong business acumen and therapeutic expertise
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