USGlobal Senior Medical DirectorScientific Director, Medical Affairs – Multiple Myeloma
Irvine, CA - USA
Job Summary
Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care 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 commercial teams to provide strategic medical input into core brand (product) strategies and to support medical affairs marketing activities (promotional material generation and product launches) and market access.
- Provides scientific and technical support for assigned multiple myeloma 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 multiple myeloma products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
- In cooperation with other medical departments Marketing RA Clinical and other functional areas provides leadership oversight and support for assigned multiple myeloma products/projects.
- Drives medical affairs related launch activities identifies launch risks and develops & executes mitigations strategies and makes sure that medical affairs considerations are heard during regulatory negotiations
- Drives the execution of the molecule and disease specific publication plan based on the unmet needs evolving data and evolving treatment landscape through a cross functional collaboration with publication lead and clinical development team
- Drives Medical Affairs strategies and be a key internal contact/subject matter expert. Responsible for delivery of strategic alignment plan brand plan gap analysis and integrated tactical plan.
- Develops and executes innovative research concepts for clinical data generation; provides relevant scientific and technical training to internal teams globally
- Ensures appropriate selection of investigator initiated studies and maintains oversight for appropriate execution.
- Collaborates closely with HEOR and V&A team to develops and co-executes HEOR & access strategy.
- May develop of scientifically accurate marketing materials medical education programs advisories and symposia
- May assist with the scientific review development execution and communication of area/global medical affairs sponsored or supported clinical research activities.
- Keeps abreast of evolving multiple myeloma treatment landscape as well as competitive landscape other professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource and is able to translate this info into strategic implications.
- May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function.
- Provides guidance to cross-functional team members to aid in the development of promotional materials.
- Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards including regulatory guidelines to meet customer needs
- Oversees the work of a small team of Scientific/Associate Scientific Directors or Medical/Associate Medical directors
- Coordinates induction mentoring training and development of others.
- Ensures budgets timelines compliance requirements are factored into programs scientific activities.
Qualifications :
For US/Global Senior Medical Director:
- Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant multiple myeloma experience in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred.
- Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 6 years of experience is preferred.
- Substantial understanding of multiple myeloma required.
- Knowledge of clinical trial methodology data analysis and interpretation regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Ability to run a clinical study independently with little supervision.
- Proven leadership skills in a cross-functional global team environment
- Ability to interact externally and internally to support global business strategy.
- Must possess excellent oral and written English communication skills.
- People leadership experience preferred
For US/Global Scientific Director:
- Advanced Degree PhD or PharmD.
- Typically 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of multiple myeloma required.
- 7-10 years of experience in Medical Affairs with Global/US Medical Affairs experience highly preferred.
- Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent is preferred.
- Knowledge of clinical trial methodology data analysis and interpretation regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Ability to run a clinical or real-world study independently with little supervision.
- Proven leadership skills in a cross-functional global team environment
- Must possess excellent oral and written English communication skills.
- People leadership experience preferred
Additional Information :
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 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more