Job Description
Are you looking for a patient-focused,innovation-driven company that will inspire you and empower you to shine? Join us as anExecutive Medical Director, Oncology Clinical Sciencesinour Cambridge, MAoffice.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being avalues-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
OBJECTIVES:
TheExecutive Director(ED)is responsible forensuring ongoing review and agreement of thetherapyareastrategy and associated documents formulated by theOncology Therapeutic Area Unit (OTAU)prior to their review and approval byappropriate governancecommittees.The ED oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP)while alsoresponsible forthereview of synopses, other relevant clinical study documents,andcriticalstudyresults.He or she will provide leadership and oversight of respective clinical developmentactivity, including the management of a team of individuals responsible for the conduct of clinical trials within a program.He or she is also responsible for providing guidance toOTAUleaders on regional specificities withinthe therapeuticarea.
ACCOUNTABILITIES:
- Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies.
- Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds.
- Overseesthestudyphysician(s)and/or clinical scientist(s)leadsresponsible for the conduct and data review of program studies.Emphasis willbe oninsuring that the development teams are proactivelyidentifyingcontingencies, potentialrisksand strategies to address future obstacles.
- Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical
- Development Plan and Clinical Protocols. Recommends scope,complexityand size, which influence the budget of all aspects of a program.
- Provides continual critical evaluation of the development strategy tomaintaina state-of-the-artdevelopment plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
- Responsible for high impact global decisions: interpreting data from ongoing internal and external studies,assessing the medical and scientific implications and making recommendations that impact regional andglobal development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
- Plans clinical development strategies incontextof medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medicalneed.
- Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the globalstrategydocumentation and that stakeholders are appropriately briefed.
- Providing strategic input into global development strategies and plans for all compounds in OTAU.
- Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities)
- Primary interface with Medical Affairs team for strategy and to support of product commercial efforts
- Contributing to the creation and maintenance of regional KOL network
- Providing recommendations for GDT leader nominations and reviewers of external compounds as part of businessdevelopment efforts
- Liaison with Clinical Operations and Project Management for co-ordination oflogisticsstudy planning and implementation
- Consistent with membership of the Clinical Review Board Committee, responsible for critical review of Synopses, protocols,
- IBs and relevant clinical documents relating to studies in assigned compounds.
- Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.
- Oversees andleadsall clinical science activities involved in interactions with FDA, other regulatoryagenciesand key opinion leaders relevant to assigned compounds.
- Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment.
- Proactive identification of challenges and development of contingency plans asappropriate.
- Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment.
- Conducts due diligence evaluations, ofclinical development plans for potential alliances and or in-licensing opportunities.
- Serves as clinical contact point for ongoing alliance projects and interface withpartnerto achieve Takeda’s strategic goalswhile striving tomaintaingoodworking relationship between Takeda and partner.
- Assigns and manages clinical science staff who are involved in many of these activities.
- Interacts directly withresearchdivision based on pertinent clinical and developmentexpertiseand in all aspects relating toassignedcompoundin regionalarea. Leads TGRD internal teams and global cross-functional teams.
- Works with functionalleadership to prioritize projects within the therapeutic area.
- Hires, manages, mentors, motivates, empowers,developsandretainsstaff to support assigned activities. Conductsperformance reviews and drive goal setting and development planning.
EDUCATION, EXPERIENCE,KNOWLEDGEAND SKILLS:
- MD or combined MD/PhD or internationally recognized equivalent with minimum 10yearspharmaceutical research experience, including minimum 7 yearsphasesI-IV clinical development experience.
- Training and Experience in Hematology and/or Medical Oncology especially hematologic malignancies is highly preferred
- Previousexperience in successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Development experience beyond US/EUa plus.
- NDA/MAA/Submission experience strongly preferred
- Experience with anddemonstratedability to lead and manage highly trained medical,scientificand technical professionals preferred
- Superior communication, strategic,interpersonaland negotiating skills
- 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 across multinational business cultures
TRAVEL REQUIREMENTS:
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may berequired.Requires approximately10%travel.
About Us
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
Takeda is an equal opportunity employer.
For applicants of U.S and Puerto Rico positions: Click [here ](https://www.takedajobs.com/eeo-statement)to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click [here](https://www.takedajobs.com/accommodations-statement).
