Opening For Associate Medical Director/Medical Director - Chicago

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Amar Annamalai
Amar Annamalai's picture
Opening For Associate Medical Director/Medical Director - Chicago

 Key Responsibilities Include:
 
Provides 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).
Works closely with sales, marketing andcommercial teams to provide strategic medical input into core brand (product) strategies, and to support medical/marketing activities (eg, generation/product launches) and market access.
Provide scientific and technical support for assigned products; deliverscientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products;develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
In cooperation with affiliate medical departments, Marketing, RA, Clinical andother functional areas, provides leadership, oversight and support for assigned products/projects.
Coordinates training, identifies training needs, and clinical developmentstrategic initiatives in the context of medical affairs.
May supervise 0-10 employees either directly or in a matrixed environmentdepending on role and level of responsibility.
Establishes and approves scientific and medical initiatives that are inalignment with the overall strategic initiatives of global medical affairs.
Participation in design and execution of clinical trial safety, product safety and risk management plans.
May also carry responsibility for routine andadhoc safety monitoring reports to regulatory agencies. May review, assess andreport 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 andis medically and scientifically accountable for resolution of safety (AE’s& SAE’s) issues, interpretation of statistical analyses for clinical significance, Private Investigator selection, scientific documents reportingsafety 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 productregistration or to generate data for label inclusion remain the primary responsibility of therapeutic area development teams.
Drives medical affairs activities and generation and dissemination of datasupporting overall product scientific and business strategy.
May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinial operations, discovery,statistics, regulatory, etc…) as they relate to on-going medical affairs projects.
May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
Oversee scientific/medical education of investigators, clinical monitors, andGlobal 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.
Represents AbbVie at external meetings including investigator meetings,scientific association meetings, Medical/Clinical Advisory Boards .
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 act as medical/scientific leader for several programs within an area.
May represent the medical function to the GPT, GCT, GRPT, Asset Teams,and other cross-functional team meetings as needed.
May develop scientifically and medically accurate marketing materials, medicaleducation programs, advisories, and symposia.
May assist in developing/mentoring junior medical affairs staff
Assists with the scientific review, development , approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
Basic:
 
US: Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty (internal medicine) in an academic or hospital environment.
Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
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 (Internal Medicine).
Ability to interact externally and internally to support global business strategy.
Must possess excellent oral and written English communication skills.
Preferred:
 
Completion of residency and/or fellowship. At least one further major international language.
Academic qualification (Dr med or equal).Completion of residency and/or fellowship.
Hire could be at Associate Medical Director or Medical Director level. The level will be determined through assessment of education and relevancy of experience. This position is on apart time basis working 3-4 business days.
 
Key AbbVie 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 suggestions and experimentation for improvement
Embraces the ideas of others, nurtures innovation and manages innovation to reality
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