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Assistant/Associate Scientific Director, US Medical Affairs- Oncology
4 months ago
Company Description
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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The Assistant/Associate Scientific Director provides medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions (Payers, Patients, Prescribers, and 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 and safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical and marketing activities (promotional material generation and product launches) and market access. Collaborates with clinical development on Medical Affairs support of priority trials.
Responsibilities
With oversight, contributes to the development of brand strategies. Actively contributes to the development of a TA EE Engagement Plan.Leads and support Medical Affairs initiatives for the target indication.Develops and executes Medical Affairs support of priority clinical development trials.Contributes to the development of and leads the execution of the Medical Education / Advisory Board & EE Engagement Plan generation in line with TA plan. Lead the individual (Global) Conference planning and execution.Generates clinical and scientific data per evidence gap assessment.Responsible to manage budget for assigned projects.Aligns Medical education and scientific initiatives with Sci Comm Platform. Informs Investigator Initiated Study (IIS) strategy and can act as Docent for IISs.Contributes to the generation of MI communication content and supports training on Medical Information (MI) materials.Participates in design and execution of clinical trial safety, product safety and risk management plans. Track RMP implementation.Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.Qualifications
Associate Scientific Director Qualifications:
Bachelors Degree in the sciences. Advanced Degree PhD, PharmD, PA or NP preferred. Residency oradditional post doctorate experience preferred.7+ years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.May have performed protocol design in the academic environment and/or acted as an assistant PI.Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written communication skills.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.May assist as consultant and 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.Works with some supervision and guidance. Exercises judgment within well-defined practices and policies.Assistant Scientific Director Qualifications:
Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred.3-5 years of clinical, scientific/research, or industry related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Substantial understanding of relevant therapeutic area required.Good understanding oflegal andregulatoryguidelines(e.g.knowledge ofOPDP promotionalregulations,CDER/CBERregulationsastheyrelatetodrug approvals).Good understanding ofGoodClinicalPractices,ICHguidelines,PhRMA code,FDACFR,ISO, clinicalresearch ethics,HIPAA and patient privacylaws, EUDirective and other applicablelocalregulationsGood understanding ofMedicalAffairs principles,study design and publications.Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.Ability to interact externally and internally to support global business strategy. Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills.Able to coordinate 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.Ability to work effectively in a team/matrix environment. Ability to influence others without direct reporting relationships.Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
This job is eligible to participate in our short-term incentiveprograms.
This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.
