Sr. Medical Director, Latin America Regional Lead Hepatitis C

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.

Primary Job Function
 Medical Affairs: participates in medical affairs activity related to the generation and dissemination of data supporting overall product scientific and business strategy. Specifically, responsible for direction, planning, and execution of phase
IIIb/IV studies, investigator initiated studies, registries, database mining, and HEOR studies. Also responsible for direction, planning and execution of publications, scientific presentation, guideline dossier development, interactions with key physicians, media and investor relations.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- 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 and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical/marketing activities (promotional material generation/product launches) and market access.
- Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant regional Brand Team and develops medical affairs strategies for assigned products in region; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training
- Contribute to  the design  of clinical development plans based on strong medical and scientific principals, knowledge of the regulatory requirements and AbbVie’s customers, markets, business operations and
emerging issues.
- May manage the design, conduct and reporting of clinical trials in line with the development, regulatory and commercial strategy.
- May supervise 2-10 employees either directly or in a matrixed environment.
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- Participation in design and execution of clinical trial safety, product safety.
- Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. and risk management plans. Responsible 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.
- - 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 clinical or 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, 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.
- Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.-
- May represent the medical function to the Global Project Team (GPT) for medical affairs and/or clinical development activities.
- May assist in the development of scientifically accurate marketing materials, medical education programs, advisories and symposia.
- May assist in developing/mentoring clinical science managers (MSLs) within the therapeutic area.
- May assist with the scientific review development and communication of investigator initiated studies.
- May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple
subprojects within the therapeutic area.
- Drive Medical Affairs strategies and be a key internal contact/subject matter expert.
- With Medical Affairs Therapeutic Area Lead (MA TA Lead) , contribute to  setting global HCV medical affairs strategy  and overall medical affairs objectives.
- With MA TA Lead, ensures budgets, timelines, compliance requirements are factored into programs' scientific
activities.
POSITION ACCOUNTABILITY / SCOPE:
- Works independently.
- Can address complex problems within discipline or across several projects.
- Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.
- Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors.

Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
7+ 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 complex clinical program or medical
affairs team(s) independently. Extensive knowledge of medical affairs  methodology, regulatory requirements governing
medical affairs  and experience in development medical affairs strategies. This knowledge set is typically associated with a minimum of 7 years of clinical development or medical affairs experience in a pharmaceutical company/
CRO/Bio Technology company plus expert knowledge in a relevant therapeutic specialty. Must have an understanding of Pharmacovigilance practices.
Ability to interact externally and internally to support global business strategies.
Must possess excellent oral and written English communication skills. Ex-US: At least one further major international language is preferred.
Must have an in-depth understanding of the Clinical Development process for Phase I-IV and extensive knowledge of medical affairs including compliance and regulatory requirements.

EDUCATION:
- US: Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty (hepatology, GI, or ID) in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
- Ex US: 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.
Advanced academic qualification is warranted.