Provide specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities).
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Key Responsibilities:
Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy
Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies.
May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies
Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams
May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects.
Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information
Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities
Can address complex problems within discipline/project or across disciplines
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors
Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance
Qualifications
Basic:
Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty (Urology) in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal) is strongly preferred. Completion of residency and/or fellowship is preferred
Minimum of 2+ years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred. Proven leadership skills in a cross-functional global team environment
Ability to interact externally and internally to support global business strategy. Ability to run a clinical study or medical affairs team independently with little supervision
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
Expert knowledge in a relevant therapeutic specialty. Ability to interact externally and internally to support global business strategy
Must possess excellent oral and written English communication skills
Key Leadership Competencies:
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
Learns fast, grasps the 'essence' and can change the course quickly where indicated
Raises the bar and is never satisfied with the status quo
Creates a learning environment, open to suggestion and experimentation for improvement
Embraces the ideas of others, nurtures innovation and manages to reality
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