Senior Director, Global Medical Affairs, Multiple Myeloma

About AbbVie
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.

Medical Affairs 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). In addition, the Medical Director works closely with sales, marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and supports medical/marketing activities (promotional material generation/product launches) and market access. Lastly, he/she will provide scientific and technical support for assigned products; deliver scientific presentations; develop and maintain 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.

Key Responsibilities:

• Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy
• Participation in design and execution of clinical trial safety, product safety and risk management plans
• May also carry responsibility 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
• All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams
• 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 medical affairs projects
• Provide scientific/medical education to 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
• 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 assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia
• Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities
• Can address complex problems within discipline/project or across disciplines
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors
• Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance

Qualifications

Basic:

• Advanced education (e.g., PhD, PharmD, PA, NP) Residency or/+ post doc highly preferred. 

• 5+ yrs. experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area.

• Multiple Myeloma or Hematology knowledge or experience preferred

• Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ 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 clinical study or medical affairs team independently with little supervision
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
• Will supervise a team but must be able to influence in a matrixed environment. Works mostly independently with limited guidance
• Expert knowledge in a relevant therapeutic specialty. Ability to interact externally and internally to support global business strategy
• Must possess excellent oral and written English communication skills
• Ex-Us: At least one further major international language is preferred

Key Leadership Competencies:

• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
• Learns fast, grasps the 'essence' and can change the course quickly where indicated
• Raises the bar and is never satisfied with the status quo
• Creates a learning environment, open to suggestions and experimentation for improvement
• Embraces the ideas of others, nurtures innovation and manages innovation to reality Position may be hired as a Scientific Director depending on degree and experience. Qualifications are below:

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 25 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.