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 28,000 people worldwide and markets medicines in more than 170 countries.
PRIMARY JOB FUNCTION:
CORE JOB RESPONSIBILITIES:
- Clinical Development: Oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities of one or more clinical development programs. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators and negotiates study design. Responsible for creating clinical development plans and for directing human clinical trials, phases I – IV for company products under development. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops reporting information for reports submitted to Global Regulatory Authorities, including EMEA, FDA, and other national authorities. Monitors adherence to protocols and determines study completion. May act as consultant/liaison with other corporations when working under licensing agreements.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
POSITION ACCOUNTABILITY / SCOPE:
- Accountable for the design and management 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. Responsibility may extend from early translational development activities to mature product life cycle management strategies.
- Manages the design, conduct and reporting of clinical trials in line with the development, regulatory, and commercial strategy.
- May supervise 2-8 employees either directly or in a matrixed environment.
- Should be able to serve as a global product safety offices, and will collaborate with global product safety teams.
- 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, medical affairs, etc.) as they relate to on-going clinical projects.
- May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
- Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
- 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 as as medical/scientific leader for several clinical programs within an area.
- May represent the medical function to the GPT for clinical development activities.
- May assist Medical Affairs in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
- 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.
- With project director, responsible for setting clinical trial strategy to carry out overall program objectives.
- With project director, ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
- 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 Experience / Training Required for Sr. Medical Director level:
- US: Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
- Ex US: National licence 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.
Minimum of 5 years of clinical trial experience in the pharmaceutical industry or academia or equivalent. 7+ years of experience is preferred. For Medical Director level, minimum of 2 years of clinical trial experience in the pharmaceutical industry or academia or equivalent required, 3+ years 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 independently. Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. 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 for Clinical Development programs. 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 knowledge of compliance and regulatory requirements.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Yes, 5 % of the Time