Executive Medical Director, Translational Medicine (Immunology)

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose :

The primary objective is to plan and execute on the safety strategy for Immunology assets or potential assets in early development, and to supervise, manage and mentor the MSE staff supporting those assets during due diligence and development

Responsibilities : 

• Provides oversight of the Product Safety Teams (PSTs) and manages other physician colleagues within Medical Safety Evaluation (MSE) in order to translate nonclinical and early clinical safety findings to facilitate benefit-risk decision making and risk mitigation in clinical development through phase 2a for AbbVie GI, dermatology and rheumatology development programs.


• Oversees Group Medical Directors who represent MSE on the Asset Strategy Teams.


• Interacts with and influences other cross functional departments (e.g. Toxicology, Pharmacokinetics, Business Development, Clinical and Regulatory Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessment to support study participants in early development programs.


• Represents MSE at the TAPR, TAT and DSEC meetings for early development compounds.


• Collaborates with Benefit Risk Management to help AbbVie identify and prioritize lead targets for therapies in immune-mediated disorders.


• May represent MSE in Search and Evaluation discussions with potential external licensing partners and/or may be involved in potential business development decisions.


• Represents MSE in assigned due diligence activities for immunology, and coaches/oversees direct reports in the conduct of such activities.


• Provides strategic input for key safety documents (such as the Investigator’s Brochure or Development Safety Update Report) for early development assets, and may delegate review to direct reports, as appropriate.


• Assures all issued safety documents contain high quality medical safety content and are clearly written.


• Supervises and coordinates with the Product Safety Team Leads the communication of major safety issues for assigned products (as appropriate) to various cross-functional teams.


• Communicates major safety issues to management groups such as the leadership team of RQS, governance bodies such as the Safety Review Board and the Complaint Management Review Board.


• Coaches and mentors MSE staff and solicits relevant feedback from outside MSE to assist each employee in their development and succession planning.


• Drives process improvement and change management in concurrence with company-wide and functional plans.


• Drives and advances medical safety capability and capacity both strategically and with innovative approaches.



 
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Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications :

• MD, DO or equivalent Medical Degree with direct patient management beyond residency and/or a PhD in Clinical Pharmacology or Immunology is required. Expertise in translational science and/or early research in immune mechanisms of disease, as demonstrated, for example, through a peer reviewed publication record.


• Experience participating in due diligence exercises to inform go/no-go decisions is required.


• Minimum of 5+ years’ experience in drug safety or related discipline within the pharmaceutical industry, with experience in evaluation of drug safety during early development.


• At least three years’ experience in managing people is required.


• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols


• Ability to exercise judgment and address complex problems and create solutions across multiple projects


• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.


• At least 1-2 years’ experience in clinical development is preferred.


• Experience in leading multi-disciplinary teams is preferred.  



 
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Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie 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.