Medical director Jobs in Irvine, CA

Job Description

*Lake County, IL preferred; Florham Park, NJ, Waltham, MA, San Francisco, CA, and Irvine, CA will also be considered. Hybrid schedule of Tues-Thurs in office is required.

*Position title will be based on qualifications listed below.

Purpose:

The Senior Scientific Director / Executive Medical Director 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 drive 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). Works in collaborations/alliances and supports the various associated governances that may be with

Responsibilities:

• In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory, HEOR and other functional areas, provides leadership, oversight, and support for Epcoritamab and Ibrutinib. Works closely with Brand Teams and relevant cross-functional, area/affiliate medical teams, to provide strategic input into core asset strategy, and is responsible for executing medical activities for Epcoritamab and Ibrutinib.
• Medical affairs team lead of various products and Epcoritamab and Ibrutinib governances and responsible for the medical functional plan, brand plan, and integrated evidence plan. This would include the lead for governances including being chair/co-chair for various Abbvie and/or alliance governances.
• Medical affairs team lead for multiple assets and leading other team leaders responsible for the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
• 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.
• Drives medical affairs Epcoritamab and Ibrutinib activities and generation and dissemination of data supporting overall product scientific and business strategy. Coordinates induction, mentoring, training, and development of team members.
• 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 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 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 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. Works independently. Can address complex 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.

Qualifications

Executive Medical Director Qualifications:

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D.) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred. National license to practice medicine preferred.
• Minimum of 5 years of clinical trial experience in the biotech/ pharmaceutical industry or academia or equivalent. 7+ years of experience is preferred.
• Proven leadership skills in a cross-functional team environment. People management experience preferred.
• Ability to run a clinical program or medical affairs team(s) independently with little supervision.
• Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols.
• Expert knowledge in a relevant therapeutic specialty. Experience in a senior role in a TA preferred.
• Must have an understanding of the Pharmacovigilance practices for Clinical Development programs.
• Must have an in-depth understanding of the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements. Must possess excellent oral and written English communication skills. Ability to interact externally and internally to support business strategy. International experience is a plus.

Senior Scientific Director Qualifications:

• 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.

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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