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Executive Medical Director - Medical Safety

Company: BetterHelp
Location: Concord
Posted on: September 12, 2020

Job Description:

Executive Medical Director - Medical Safety Company: Takeda

Location: Cambridge

Posted on: September 3, 2020

Job Description:

The Executive Medical Director is responsible for:Oversight ofmedical safety activities and processes for the GPSE Medical SafetyMarketed Products Group with ensuring the continuous assessment ofthe safety profile and of the benefit risk of the portfolio ofMarketed Products; Timely escalates safety issues to Chair, TakedaSafety Board as required; Provides strategic and Patient focusedleadership and vision for further development of medical safety TAin support of asset strategy; Strengthens Patient focused medicaland scientific excellence/innovation; Oversees capability andcapacity planning in allocated TA. Defines and implementsfunctional vision for Patient safety; Further advances robust andinnovative medical safety capabilities on level setting businessprocesses with leading industry standards; Core member ofcompany-wide Committees and Governance.OBJECTIVE:-- Core member ofthe Global Patient Safety Evaluation (GPSE) LeadershipTeamMaintains and develops innovative medical safety capabilities,Develops and implements Patient focused functional visionOversightof cross functional Safety Management Teams for allocatedTAResponsible for management of physicians and Health CareProfessionals (HCPs) who serve as the Global Safety Leaders (GSL)and PV Scientists for Marketed ProductsInteracts with andinfluences other cross functional departments (e.g. DevelopmentOperations, Regulatory Affairs, Medical Affairs, Global Evidence &Outcomes (GEO); Data Science Institute, Clinical Science, etc.) toensure the successful development, design and implementation ofcomprehensive safety and benefit risk assessment for MarketedProductsOversees and manages signal and risk management activitiesundertaken by the GSLs and PV Scientists and ensures thatcomprehensive safety assessment plans are in placeOversees andmanages any emerging safety signal although the primaryresponsibility will reside with the GSL. The position holder willhave a pivotal role in managing contributions/presentations toTakeda Safety Board and company- wide Committees andgovernancesDevelops medical safety operational processframeworksDrives process improvement and change management inconcurrence with company-wide and functional plans---- --Drives andadvances TA medical safety capability and capacity bothstrategically and with innovativeapproaches------------------------------------------------------------------------ACCOUNTABILITIES:--Ensures, in conjunction with Head, GPSE and other functions withinGPSE, effective functioning of the department including strategicand long-term planning and resource assessmentsContributes in thedevelopment and implementation of innovative and Patient focusedstrategies to support medical and scientific safetyexcellenceMaintains and develops perspectives to enhance GPSEinnovation from external expertise and network----In conjunctionwith other TALs, Medical Safety and other relevant GPSE/crossfunctional disciplines leads and coordinates interpretation ofsafety data from internal and external studies/sources andcommunicates at senior leadership level the impact of same both interms of "go/no go" decisions or modification of development planor study design, including potential impact on developmental andregistrations timelines or product labelingResponsible forreviewing, analyzing and interpreting safety information fromongoing clinical and non-clinical studies, alongside the assessmentof ensuring scientific and medical implications. Further,coordinates/leads recommendations derived from emerging new safetydata for developmental compounds and marketed drugs, ensuring theprimacy of Patient safetyLeads and/or participates along with GPSEand cross functional colleagues to the development of a globalconsensus on signal and risk management tools and activitiesAs oneof the most senior physicians in GPSE will mentor other PVphysicians and HCPs for adequate safety monitoring and signal/ riskmanagement assessment and analysis for MarketedProducts--Responsible for presentations to Takeda Safety Board andother company wide Committees and Governance and facilitates crossfunctional interactions (within and outside GPSE for same. Asappropriate the position holder will directly involvehimself/herself in presentations to Safety Board, recognizing thatthis will primarily reside with the GSL and will ensure follow upto requests from Safety Board--Attends corporate committees andexternal Boards representing the Marketed Products therapeuticareaOversees the medical safety evaluation of projects by the GPSEphysicians and HCPs for new business development, potentialin-licensing opportunities (e.g. due diligence evaluations) andPharmacovigilance Agreements with Business Partners --Supervisesthe allocated medical safety team in the preparation, analysis andpresentation of safety information, compilation of highest qualityand medical interpretation of safety data in support of safetyupdate regulatory submissions, new drug applications andinteractions with Regulatory Authorities worldwideEnsures theoversight of safety related activities performed by partners andCROs specifically for quality and performanceAnticipates regulatoryimplications of emerging safety issues and develop strategies forhandling/managing such issues, Directs GPSE interactions withRegulatory AuthoritiesEnsures that GPSE physicians and HCPs areproactively identifying safety concerns and developing contingencystrategies that address these challengesAssists in optimizing GPSEcapacity and capability planning and executionLeads and/orcontributes to initiatives across disciplines and crossfunctionally--Contributes to creating and communicating anenvironment culture and values which attract, inspire, retain anddevelop the most effective talents at all levels to maximize theircareer development and contribution to the Business --Maintainsknowledge of products and product environmentMaintains expertiseand awareness/understanding of international PV regulatoryrequirements (FDA, EMA, PMDA) and guidelines (CIOMS, ICH); Ensurescompliance with regulatory and medical/scientific standards andguidelines-- ----------Maintains professional knowledge andaccreditation by active participation in continuing medicaleducation activitiesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Medical Degree (MD) required or internationally recognizedequivalent, ideally combined with Advanced Degree (e.g. PhD/Masterin a medical or Epidemiology or Public Health discipline).Minimumof 5 years of experience in people management10 years+ experiencegained in Pharmacovigilance, Clinical Research or ClinicalDevelopment within Pharmaceutical industry and/or academia and/orCRO including significant experience in operating in a globalpharmacovigilance organization.Demonstrated knowledge of regulatoryagency requirements regarding drug safety and an understanding ofgeneral drug safety methodologies.Ability to comprehend andsynthesize complex data and should have experience in theidentification, analysis and implementation of programs andprocedures required to achieve corporate objectives.Experience ofoperating in a multi-disciplinary drug development environmentincluding international experience and exposure to a variety oftherapeutic areas.Experience working in an outsourced environmentmanaging suppliers, CROs, vendors and strategicpartnerships.--Identifies opportunities and anticipates changes inthe medical safety landscape through an understanding and ongoingassessment of the environment affecting Patient.Developspartnerships with internal and external stakeholders strategicobjectives.Inspires commitment through a wide range ofcommunication channels (meetings, writing, presentations) anddemonstrates integrity.Must have demonstrable experience in peoplemanagement at a leadership level and well-developed skills inteam-building, motivating, empowering and developing people.Workproductively in a fast moving and pressured environmentGoodanalytical/judgment capabilities to understand, analyze/synthesizeand communicate successfully and conciselyWell-developed timemanagement skill-set to assist prioritization of multipleissuesComputer literate, including safety databaseacumenSelf-resourced, with confidence to take the initiative andact autonomouslyBoth facilitates and efficiently leads meetings,both in person and other mediaExcellent communication skill-set,orally and presentational--Proven ability to work globally andcross-functionally, with strong interpersonal skills /appropriatelyassertive /team minded and mentoring?TRAVEL REQUIREMENTS:Local andinternational travel across Takeda sites will--be required up to amaximum of 25%.WHAT TAKEDA CAN OFFER YOU:401(k) with company matchand Annual Retirement Contribution PlanTuition reimbursementCompanymatch of charitable contributionsHealth & Wellness programsincluding onsite flu shots and health screeningsGenerous time offfor vacation and the option to purchase additional vacationdaysCommunity Outreach Programs

Keywords: Takeda, Cambridge , Executive Medical Director - Medical Safety, Healthcare , Cambridge, Massachusetts

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