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Medical Director

Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: September 17, 2020

Job Description:

Medical Director / Senior Medical Director, Clinical Science Company: Takeda Pharmaceuticals International GmbH

Location: Boston

Posted on: September 12, 2020

Job Description:

The health and safety of our employees and candidates is veryimportant to us. Due to the current situation related to theCoronavirus (COVID-19), we’re leveraging our digital capabilitiesto ensure we can continue to recruit top talent at Takeda. As yourapplication progresses, you may be asked to use one of our digitaltools to help you through your recruitment journey. If so, one ofour colleagues will explain how these tools will be used during therecruitment process. Thank you.

*Please be aware of an Identity Theft Scheme targetingindividuals seeking jobs with Takeda and other employers. See belowor here for more info.

Medical Director / Senior Medical Director, Clinical ScienceTakeda fosters a collaborative and stimulating work environmentfilled with opportunity and the chance to make a difference inpeople's lives. It is a workplace driven by integrity, one ofTakeda’s long-held values that extends to both the patients weserve and our employees who develop and deliver medicines. Acrossour company, Takeda employees bring together diverse strengths thattogether create a stronger whole.

As one of the world’s leading biopharmaceutical companies,Takeda is committed to bringing Better Health and a Brighter futureto people worldwide. We aspire to bring our leadership intranslating science into life-changing medicines to the next level,in our core focus areas; oncology, gastroenterology, neuroscience,rare diseases, plasma-derived therapies, and vaccines. The GreaterBoston Area is headquarters to many of our Global and US businessunits.

We are a passionate team doing important work that impactspatients’ lives. If you are driven to create better health and abrighter future, join us!

Success What makes a successful member of our team? Check outthe traits we’re looking for and see if you have the right mix.

Life at Takeda A Global Top Employer Recognized for our cultureand way of working, we’re one of only select companies to receiveTop Global Employer ® status for 2020.

Medical Director / Senior Medical Director, Clinical Science JobID R0021364 Date posted 07/24/2020 Location Boston,Massachusetts

Are you looking for a patient-focused, innovation-driven companythat will inspire you and empower you to shine? Join us as anMedical Director / Senior Medical Director, Clinical Science in ourCambridge, MA office.

At Takeda, we are transforming the pharmaceutical industrythrough our R&D-driven market leadership and being a values-ledcompany. To do this, we empower our people to realize theirpotential through life-changing work. Certified as a Global TopEmployer, we offer stimulating careers, encourage innovation, andstrive for excellence in everything we do. We foster an inclusive,collaborative workplace, in which our global teams are united by anunwavering commitment to deliver Better Health and a BrighterFuture to people around the world.

Here, you will be a vital contributor to our inspiring, boldmission.

OBJECTIVES:

The Medical Director leads and drives strategy for the overallglobal (US/EU/Japan) clinical development taking into considerationthe medical, scientific, regulatory and commercial issues forassigned Takeda pipeline compounds. Leads a multi-disciplinary,multi-regional, matrix team through highly complex decisions. Thisindividual has the ultimate responsibility for developmentdecisions assessing and integrating the input from variousdisciplines to create, maintain, and execute a global clinicaldevelopment plan that will result in the regulatory approval of theassigned compound in multiple regions. Applies clinical/medicaldecision making to clinical development issues. This individualinteracts with and influences TGRD and TPC senior leadershipdecision-making for the projects by setting strategic direction.Success or failure directly translates to the ability of TGRD tomeet its corporate goals and for Takeda to have future commercialproducts.

ACCOUNTABILITIES:

Clinical Development team participation and leadership LeadsGlobal (US/EU/Japan) Development Team managing both the US/EUDevelopment Team and the Japan Development Team for a givenproduct. May lead the US/EU Development Teams and representsClinical Science on the Global (US/EU/Japan) Development Team toensure that activities are aligned with the global strategy.

Establishes and drives Development Team strategy anddeliverables producing the Development Strategy, ClinicalDevelopment Plan and Clinical Protocols.Recommends scope,complexity and size, and influence the budget of all aspects of aprogram.Provides continual critical evaluation of the developmentstrategy to maintain a state-of-the-art development plan that iscompetitive and consistent with the latest regulatory requirements,proactive identification of challenges, and development ofcontingency plans to meet them.

Responsible for high impact global decisions: monitoring andinterpreting data from ongoing internal and external studies,assessing the medical and scientific implications, and makingrecommendations that impact regional and global development such as“go/no go” decisions or modification of development plans or studydesigns that may have a significant impact on timelines or productlabeling.A significant error in judgment may result in loss ofapprovability and commercial viability of a product.

Synopsis / Protocol Development, Study Execution, & StudyInterpretation Drives clinical science activities relating to thepreparation / approval of synopses, protocols and the conduct ofclinical studies.Serves as an advisor to other clinical scientistsinvolved in these activities, and is accountable for the successfuldesign and interpretation of clinical studies.Presents studyconclusions to Management and determine how individual studyresults impact the overall compound strategy.

Interprets data from an overall scientific standpoint as well aswithin the context of the medical significance to individualpatients.

Trial Medical Monitoring Responsible for medical monitoringactivities, assessing issues related to protocol conduct and/orindividual subject safety.Assesses overall safety information forstudies and compound in conjunction with Pharmacovigilance.Overseesnon-medical clinical scientists with respect to assessment of theseissues.

Makes final decisions regarding study conduct related toscientific integrity.

External Interactions Directs activities involved ininteractions with regulatory authorities / agencies and clinicaldevelopment activities undertaken to establish and maintain strongrelationships with key opinion leaders relevant to assignedcompounds and therapeutic areas.These responsibilities includeleadership roles in meetings with the regulatory organizations orkey opinion leaders, establishment of strategy for assignedcompounds, and the direction of clinical scientists involved indeveloping documents required to outline the Company positions onresearch programs or regulatory applications (e.g. briefingreports), materials used for meeting presentations, and formalresponses to communications received from the regulatoryorganizations or opinion leaders.Lead roles will also be taken onthe incorporation of advice / recommendations received into thedesign of clinical studies / programs as appropriate; accountableto senior leadership for the successful completion of relatedobjectives.

Due Diligence, Business Development and Alliance ProjectsResponsible for identification and evaluation of potential businessdevelopment opportunities, conduct due diligence evaluations, anddevelopment and negotiation of clinical development plans forpotential alliances and or in-licensing opportunities.Assessesscientific, medical, and development feasibility, evaluatingstrategic fit with overall portfolio, evaluating complete orongoing clinical trials, assessing regulatory interactions andfuture development plans, interacting with upper management ofpotential partner/acquisition companies during DD visits andalliance negotiations, and representing clinical science oninternal assessment teams in conjunction with TPNA/TPEU/TPC.

Serves as clinical contact point for ongoing alliance projectsand interface with partner to achieve Takeda’s strategic goalswhile striving to maintain good working relationship between Takedaand partner.

Interacts directly with research division based on pertinentclinical and development expertise and with TPNA/TPEU to provideknowledge / understanding of market environment in line with statusas TGRD scientific content matter expert for assigned compounds.Mayrepresent clinical science on multidisciplinary task forces acrossdivisions (e.g. TGRD and TPNA/TPEU/TPC).Lead TGRD internal teamsand may lead global cross-functional teams, as appropriate.

Hires, manages, mentors, motivates, empowers, develops andretains staff to support assigned activities. Conducts performancereviews and drive goal setting and development planning.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

MD or internationally recognized equivalent plus 5 years ofclinical research experience within the pharmaceutical industry,CRO health-related consulting company, or biomedical/clinicalexperience within academia (or a combination of aforementioned).

Previous experience successfully leading a clinical developmentteam/matrix team with responsibility for studies in multipleregions.

NDA/MAA/Submission experience preferred.

Skills

Superior communication, strategic, interpersonal and negotiatingskills

Ability to proactively predict issues and solve problems

Ability to drive decision-making within a multi-disciplinary,multi-regional, matrix teams

Diplomacy and positive influencing abilities

Knowledge

Therapeutic area knowledge relevant to mechanism of action

Regional/global Regulatory requirements

Emerging research in designated therapeutic area

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement ContributionPlan

• Tuition reimbursement Company match of charitablecontributions

• Health & Wellness programs including onsite flu shots andhealth screenings

• Generous time off for vacation and the option to purchaseadditional vacation days

• Community Outreach Programs

Check out where you could be

working if you apply.

Job Seekers: Protect yourself against identity theft Please beaware there are instances of identity thieves postingTakeda-branded jobs and posing as employees to steal personalinformation. They visit job-related websites and invite candidatesto online chats. During the chat, they press job seekers to providebank account information and Social Security numbers.

Copyright 1995-2019 Takeda Pharmaceutical Company Limited. Allrights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Medical Director / Senior Medical Director, Clinical Science, Other , Boston, Massachusetts

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