[Remote] Scientific Director / Senior Medical Director, Multiple Myeloma (International Medical Affairs)

Note: The job is a remote job and is open to candidates in USA. AbbVie is committed to discovering and delivering innovative medicines and solutions that address serious health issues. The Scientific Director / Senior Medical Director will provide specialist medical and scientific input into strategic and operational medical affairs activities, ensuring the integrity and safety of ongoing clinical projects while collaborating with various internal and external stakeholders.ResponsibilitiesInitiates medical affairs activities including data generation and dissemination strategy, development of Global Medical Affairs strategy, delivering the Medical Functional Plan, Brand Plan and working with Area and Affiliates to ensure execution of strategyResponsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions and responsesHas overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders and leadership as they relate to ongoing clinical projectsM.D.s may participate in design and execution of clinical trial safety; scientifically accountable for resolution of safety issues, safety monitoring, and other scientific reports reported to regulatory authorities. Review and assess all Adverse Events (AE’s) and Serious Adverse Events (SAE’s)Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriateAssist 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 activitiesInteract with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, market access, HEOR, clinical operations, clinical development, regulatory, etc…) as they relate to on-going medical affairs projects. Serve as the scientific team interface for key regulatory discussionsProvide 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 resourceEnsures budgets, timelines, compliance requirements are factored into programs' scientific activitiesResponsible for understanding regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirementsSkillsAdvanced Degree PhD or PharmD. Additional post doctorate experience highly preferredTypically, 10-15 years of experience in the pharmaceutical industry or related7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferredMedical Doctorate (M.D.) or equivalent (D.O. or non-US equivalent of M.D.). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship preferredMinimum 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferredSubstantial understanding of relevant therapeutic area required. Direct subject matter expertise in multiple myeloma highly preferredKnowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocolsProven leadership skills in cross-functional global team environmentAbility to interact externally and internally to support global business strategyMust possess excellent oral and written English communication skillsAdditional post doctorate experience highly preferredGlobal Medical Affairs experience highly preferredRelevant therapeutic specialty in an academic or hospital environment preferredCompletion of residency and/or fellowship preferred5 years of experience is preferredDirect subject matter expertise in multiple myeloma highly preferredBenefitsPaid time off (vacation, holidays, sick)Medical/dental/vision insurance401(k) to eligible employeesEligible to participate in our short-term incentive programsCompany OverviewAt Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. It was founded in undefined, and is headquartered in Irvine, California, USA, with a workforce of 1001-5000 employees. Its website is H1B SponsorshipAllergan Aesthetics, an AbbVie Company has a track record of offering H1B sponsorships, with 1 in 2024, 1 in 2023, 16 in 2022, 14 in 2021, 5 in 2020. Please note that this does not guarantee sponsorship for this specific role.   Apply To this Job