Medical Director, Cluster North

Job Description PURPOSE : Lead affiliate medical department.
Set and execute Medical Affairs strategies for the affiliate medical department.  Ensure the affiliate medical team contributes valuable strategic input to Global Medical Affairs (GMA) Therapeutic Area strategic medical affairs plans, and local commercial plans.  Ensure adherence to applicable company standards, policies, and procedures.  Accountable for the structure and performance of the affiliate pharmacovigilance system and operating to the highest patient safety standards.
Instill, and operate within, a culture of ethical and compliant behavior.  Ensure local medical staffing levels are appropriate to meet business requirements.  Plan, manage and be accountable for the affiliate medical department budget.  Provide strategic medical affairs support to cross-functional affiliate teams.  Provide leadership, strategic direction and mentorship to direct reports, and fulfill line management responsibilities accordingly.  Ensure that the medical department is fully integrated to support the strategy and execution of affiliate business, while being functionally independent.
  RESPONSIBILITIES: Provide Leadership, line management and development of the affiliate's medical staff.  Ensure appropriate affiliate resourcing, skills and capabilities are in place to support affiliate, regional and global medical affairs activities, global research and development activities, and business support.  Ensure clarity of roles, responsibilities & accountabilities for the affiliate medical staff.  Responsible for recruiting, retaining, and mentoring high potential employees.  In conjunction with the Regional Medical Affairs Head and local HR ensure that talent management and succession planning activities are undertaken.
Plan and manage budget and headcount resources for the affiliate medical department, in full collaboration and transparency with the affiliate commercial/finance and HR teams, and in consultation with the Regional Medical Affairs Head.  Set and execute Medical Affairs strategies for the affiliate in consultation with the Regional Medical Affairs Head to ensure alignment with region and global strategic plans.  Provide strategic input to the affiliate's commercial plans.
Development of local clinical research plans.  Conduct of local research activities in a scientific, efficient, and compliant way, with due regard to applicable policies, processes and procedures and national regulations, and alignment with areas of strategic research interest for relevant products/therapeutic areas.
Develop One R&D culture, by collaborating with and serving as a guide to CSM teams with ongoing trials in assigned countries.  Accountable for the Pharmacovigilance system within the affiliate and ensures that all local regulatory requirements are met.  Accountable for robust implementation plans for additional risk minimization measures.
Proactively anticipate possible safety signals and ensures close collaboration between functions on all safety topics, including external safety communications e.g.
Dear Healthcare Professional Communications.
Ensure that the affiliate operates an effective promotional material review & approval process, and act as final medical signatory (may be delegated) for all promotional and scientific materials / activities within the affiliate.  Act as final medical signatory (may be delegated) on all other relevant documents such as label changes, ensuring compatibility of materials with the local label.  Establish medical and scientific information service for AbbVie products and products in development and ensure that medical information is of high quality and communicated in an accurate, balanced, timely and compliant way.
Provide medical support for and help develop and maintain professional and credible relationships with external experts and academic centers.
Identify appropriately qualified external local experts who would wish to engage in collaborative efforts – such as potential research collaborations – with AbbVie; ensure a high level of scientific integrity in these collaborative efforts.
Be a strategic collaborator in, and contributor to, the affiliate FutureFit and Brand Teams, and ensure medical alignment with local objectives where possible.  Act as the primary contact for medical governance requirements within the affiliate.
Be accountable for understanding compliance requirements, risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls.
Serve as the company's key medical spokesperson and primary medical representative with governmental agencies, professional associations, special interest groups and the healthcare community at large.  Ensure adherence to applicable company standards, policies and procedures among affiliate medical staff.  Ensure compliance with all training requirements for staff.
Provide leadership of and analytical measurement approach to medical in-field team excellence in collaboration with CEx and Global Medical Affairs Operations to drive optimal Medical Affairs performance.
  INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS: Affiliate General Manager Local Heads of functions:  regulatory affairs, commercial, finance, HR, government / public affairs, market access, etc.
Global and Area Medical Affairs teams Regionally and HQ based Therapeutic Area medical affairs teams Area/Regional commercial Staff / Brand Team members Project/Medical Directors and Clinical Teams within Pharmaceutical Development and Global Medical Affairs; Global Pharmacovigilance staff CSM Country Manager Healthcare personnel (including physicians, nurses, pharmacists).
Participating Research Investigators; thought leaders/external experts.
Institutions and Scientific or Medical Societies, Local trade associations.
Hospitals, other healthcare providers, payers and Local Regulatory Authorities.
  AUTHORITY AND REPORTING LINES: This position reports into the Regional Medical Affairs Head.  Direct:  Therapeutics Area Leads, Medical Operations Manager, Affiliate Safety Representative PV Manager Qualifications Medical Degree (or equivalent scientific background); Strong background in clinical practice.  Suitably qualified individuals from a scientific background and relevant experience will also be considered.  Previous medical affairs pharmaceutical or biopharmaceutical industry experience is essential, and management experience of medical teams & significant numbers of medical/scientific staff for 5 years (minimum) is expected.  Demonstrated ability to build and lead a medical/scientific organization of significant complexity including interdisciplinary scientific teams ( For large business units) .
Demonstrated ability to build and lead a medical/scientific organization of a size similar to that in the affiliate ( For small and medium business units) .
A broad and demonstrated understanding of drug development and commercialization processes, have sound and current knowledge of the regulatory environment, significant experience in overseeing or conducting clinical trials, a solid understanding of trial design and methodology and an understanding of the need to balance safety and efficacy concerns.  He/she must have a reputation for leading with high integrity, strong work ethics and compliant behavior.
Must understand and be able to plan, manage and execute budgets effectively.
Collaborative, team-oriented approach, and will be adept at developing and supporting relationships across an organization as well as with key external stakeholders and the healthcare community at large.  Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be essential.   He/she will possess strong communication and presentation skills.  Works independently:  limited guidance/oversight.  Works broadly across functions to facilitate and support the affiliate's medical and clinical activities as necessary.
Must possess the ability to lead with confidence; a motivator of people he/she should have the ability to impart the vision and strategy of the company and of the department to others.  A strong business orientation and acumen is desirable.  He/she will have the demonstrated ability to participate within an executive team and contribute to the development and implementation of winning strategies for the company overall.  A results oriented entrepreneurial spirit with excellent judgment and the ability to operate independently.  He/she should possess the presence and credibility to establish and maintain productive relationships with a variety of audiences with an interest in the company including government regulators, the scientific community in both academic and private sector environment and other key stakeholders.
Sound judgment, strong planning and organizational skills, and the ability to get things done.
Demonstrated strong sense of urgency.
Strong leadership, communication, networking, negotiation and presentation skills.
Excellent written and spoken communication skills.
Fluency in written and oral English and local language is highly desirable in order to facilitate communications between the affiliate medical department, Global and Area Medical Affairs and other AbbVie functional staff.
Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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