For The Candidates

(770) Area Code

Sr.Medical Director

Description

Summary

The Senior Medical Director provides scientific/medical leadership to the cross functional therapeutic area medical team within Medical Affairs in order to ensure the successful implementation of the medical portion of the brand team's plan for its respective products.  The major responsibilities of the Medical Director include:

• Development of an annual medical plan designed to generate the data and scientific materials needed to meet the goals of the annual brand team business plan.
• Data generation and assessment
• Contribute to the development of Phase IIIb and IV NA clinical trials programs,
• Lead exploratory data analysis
• Lead advisory boards
• Technical mastery of the therapeutic area, including understanding of competitive intelligence
• Data dissemination-lead and supervise publication planning, educational materials development, professional presentations, medical response letters, review of all brand promotional materials and activities for medical and scientific accuracy, appropriateness and fair balance.
•  MSL team-lead and supervise therapeutic mastery, integration, and professional development
•  Education and training- lead and supervise programs for knowledge transfer to marketing , sales staff, and MSL team
• Management
• Responsible for hiring, supervision and career development of Associate Medical Directors and MSL  Associate Directors 
• Responsible for supervising the hiring and development of the MSL team in alignment with business needs
• Responsible for budget alignment with the BU and ongoing management across the team.

Major Accountabilities

• The scientific/medical expert on the therapeutic area brand team who leads the medical affairs team to ensure sound scientific strategy and content in the team's medical plans and programs and the alignment of these programs with the goals and objectives of the brand team.
• Lead and supervise the development and implementation of the Phase IIIb/IV plans for products in the BU commercial portfolio, including scientific design, site and investigator selection, budget oversight, medical conduct, results assessment and reporting for corporate sponsored clinical research.
• Lead and supervise the US MA contribution to robust EDA plans in cooperation with GMA
• Leads the US Medical Affairs activities with GMA in the concept development and execution of Phase IIIb/IV clinical studies
• Responsible for the review, approval, and oversight of IIS proposals at both the US and Global review teams.                                                                                                                                                                                                                         
• Lead the review for scientific accuracy and compliance with the contracted scope of work all final study reports submitted to the company upon completion of Company supported investigator initiated research projects.
• In coordination with Global Medical Affairs and Clinical Development, leads the US MA team in the review, evaluation and interpretation of clinical data intended to support the preparation and publication of study reports or other clinical documents.
• Lead and develop in collaboration with the Publications Manager in US Medical Affairs an effective and strategically aligned publication plan for each brand in the BU portfolio.
• Lead and develop in collaboration with the CME director the review of CME events and educational grants in accordance with Company educational programs and scientific communications and publications policies.
• Lead the planning and execution of national advisory boards and the development of national speaker materials by providing expert counsel to the brand team in setting the objectives and agendas and in selecting consultants for such advisory boards and in assessing the recommendations of these advisory boards.
• Participate in the development and execution of  global advisory board meetings in collaboration with GMA
• Develop partnerships with key opinion leaders to determine appropriate development programs for the category, remain current in the science of the therapeutic category, and  participate with medical association organizational activities as requested and in compliance with The Company’s and industry regulations
• Lead the review and approval of all materials developed for distribution to healthcare professionals by Medical Information.
• Lead the review of all marketing and promotional materials and all product related publications for medical and scientific accuracy, appropriateness, and fair balance.
• Support the corporate Education and Training programs aimed at transfer of scientific knowledge to marketing and sales staff, including programs at national sales meetings, product launch meetings, and Atlanta based training sessions.
• Lead the medical support for the managed markets team in working with the medical officers and committees, formulary review committees and utilization review committees in top managed market group, as well as Medicare and Medicaid  Medical Directors.
• Monitor on a continuous basis developments in clinical practice and medical discovery that are relevant to the product therapeutic area and may impact market behavior, and transfer this information in a timely and meaningful way to other medical team members and to brand team colleagues.
• Provide input as requested to the management of Global R&D, US and Global Medical Affairs and The Company. in matters of product development, strategic development and licensing
• Take a leading role in transitioning products from their development phase to the commercial phase of the product lifecycle. 
• Responsible for direct management of Associate Medical Directors and Associate MSL Directors including developing and supervising roles and responsibilities as well as career development.
• Responsible for the head count allocation, education, and coordination of activities of the MSL team in alignment with The Companies policies.
• Responsible for assuring all MA activities are compliant and follow The Company’s corporate policies and SOPs
• Lead the deployment of MSLs  in cross-functional teams to provide scientific and medical support for internal and external meetings and projects as needed

Qualifications

Education

• PhD degree required.  Board MD preferred.

Experience

• 15 years Medical Director/Sr. Medical Director or relevant pharmaceutical industry work experience.
• Specific experience/certification in therapeutic area highly preferred.
• Demonstrated competence in employee management and development

Specific Skills

• Demonstrates mastery of therapeutic area
• Self-directed with strong interpersonal skills, project management and strategic planning skills, team player spirit, and high capacity to function effectively in a cross-functional matrix work environment.
• Demonstrates people management skills, including networking and negotiation skills
• Proven ability to handle strategic higher-level projects.
• Successful at working interactively with commercial personnel (product managers and directors, market and brand directors).
• Proven leadership ability leading high functioning teams
• Excellent verbal and written and presentation communication skills
• Business acumen with a sophisticated understanding of the pharmaceutical industry and healthcare arena
• Proficient in Microsoft applications
• Professional demeanor and ability to handle customers both externally and internally
• Demonstrated mastery of essential job functions
• Demonstrates adaptive leadership styles and leads change management.
• Proficient at planning, decision making, analyzing, and organizing.
• Demonstrated ability to establish priorities, best practices and sets strategies
• Serves as a mentor, trainer and coach to new Managers.
• Drives the development of internal ethics, quality and compliance standards.