Medical Affairs Director - Non Hodgkin Lymphoma Lead
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Global Medical Affairs (GMA) organization provides patients, healthcare providers and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey.
Provide scientific and technical support for therapeutic assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training
- Proven ability to lead development of asset/brand strategies.
- Established track record of leading the development & execution of Medical Affairs Plans.
- Proven ability to contribute to the research platform and data generation cross-GMA: design, evaluate & execute various types of research (clinical research, Phase IIIb-IV, epi, EDA, RWE research). Demonstrated proficiency in designing & overseeing the conduct of Clinical Trials. Proficient at generating protocols, CSRs, disclosure on study details (e.g. clinicaltrials.gov). Serves as key internal subject matter expert for the TA.
- Broad understanding of the healthcare and bio-pharmaceutical environment. Proven ability to develop and execute an issue management program to anticipate, plan for and respond to issues.
- Proven ability to successfully lead and influence cross functional teams, including those with senior cross functional members. Demonstrated ability to manage brand medical affairs budget including timelines, compliance requirements.
- Proven ability to influence or lead teams that generate Scientific Publication strategy. Demonstrated ability to advance Scientific Communication Platforms content. Demonstrated ability to establish Investigator Initiated Study (IIS) strategy. Demonstrated ability to coach TA staff to be docent for IISs.
- Proven ability to influence and engage key external stakeholders. Demonstrates peer relationship with EEs.
- Represents Abbvie at external meetings (Ex. Sci or Professional Associations, PhRMA, BIO etc). May serve as unpaid peer reviewer and/or editor for scientific journals. Proficiency & Leadership in Medical Information.
- Able to influence and actively contribute to regulatory strategy, labeling and agency interactions. Proficient at generating regulatory documents. Stays abreast of key regulatory policies (especially pertinent to human research, scientific exchange and Medical Affairs) as well as regulatory guidance in the therapeutic area. Demonstrated Proficiency & active contribution in drug safety/pharmacovigilance and risk management planning and execution.
- Extensive understanding of Medical Affairs Compliance Environment & ability to educate others. Demonstrated Proficiency & Leadership in Medical Review by providing scientific guidance and issue resolution. May manage and oversee the work of Medical and/or Scientific Directors at all levels.
- Advanced Degree PhD, PharmD, PA, NP highly preferred. Residency or additional post doctorate experience is highly preferred.
- Typically 15 years’ experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area (Oncology, NHL) required.
- Medical Affairs experience highly preferred
- Management or leadership experience at the program level, experience with strategy development; senior staff role within a TA. Proven leadership skills in a cross-functional global team environment International experience is a plus.
- Ability to interact externally and internally to support global business strategy.
- Ability to run a clinical program or medical affairs team(s) independently with littler supervision. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols.
- Must have an understanding of the Pharmacovigilance practices for Clinical Development programs.
- Ability to interact externally and internally to support global business strategy. Most possess excellent oral and written communication skills.
- Can address 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.
- Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 25 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.