- In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, HEOR and other functional areas, provides leadership, oversight, and support for assigned indications/projects. Works closely with Brand Teams and relevant cross-functional, area/affiliate medical teams, to provide strategic input into core asset strategy, and to drive medical activities.
- Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Develops innovative research concepts for clinical data generation; provides relevant scientific and technical training to internal teams globally.
- Provides scientific and technical support for assigned assets; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participates in relevant Asset, Development and Pipeline Commercial cross-functional teams and drives the development of medical affairs objectives aligned with strategy.
- Provides scientific and technical input to inform the development of the Asset Target Product Profiles (TPP). Provides input in design and execution of Phase II-III trial programs including target population and endpoint selection aligned with TPP. Works cross functionally to lead the development of the asset Phase 3b/4 strategy.
- Reviews, assesses and reports applicable Adverse Events (AE's) and Serious Adverse Events (SAE's) if assigned to AbbVie conduct on clinical studies.
- Leads the development and execution of advisory boards, scientific and medical education programs. Provides scientific/medical education to all relevant internal stakeholders 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 Migraine and specific therapeutic area resource. Initiate research projects and drive them to completion, resulting in high quality publications.
- Lead functional and cross functional teams responsible for discrete projects within the specific therapeutic area (data analysis, expert engagement, individual publications, study collaborations)
- Represents Medical Affairs in due diligence activities for the acquisition of assets aligned with the Disease Area Strategy.
- Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
- Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
- Typically, 15 years' experience in the pharmaceutical industry or equivalent. Minimum of 10 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
- Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy.
- Expert knowledge in a relevant therapeutic specialty.
- Ability to interact externally and internally to support global business strategy.
- Proven ability to run a clinical study or medical affairs cross-functional team independently.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Must possess excellent oral and written English communication skills.
- People leadership experience preferred.
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Senior Scientific Director, Pipeline Medical Strategy Lead - Mettawa, United States - AbbVie, Inc
Description
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 at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.Job Description
Position is based in Irvine, CA
The Senior Director, Pipeline Medical Strategy Lead provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/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 / safety surveillance activities).
Works closely with marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical/marketing activities (promotional material generation/product launches) and market access.
Drives GMA input into and influences the development of asset strategy.Provides specialist medical insights, and executes on data generation, communication, and expert engagement activities as deliverables to relevant Asset Strategy Teams (ASTs) for both early and late stage development program including leading or contributing to:
comprehensive gap assessment, development of Scientific Communication Platform, development of integrated evidence plans to support launch readiness. Leads external stakeholder interactions (Payers, Patients, Prescribers, and Providers). Drives scientific communication initiatives (both internal and external medical education, data, guidelines and value proposition).
Responsibilities:
Qualifications
Applicable only to applicants
