By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **_Objective / Purpose:_** + **_Lead and strengthen OTAU R&D capabilities in India_** _to maximize the value for accelerating global innovation and efficiency, in alignment with global OTAU R&D goals._ + **_Ensure effective oncology operations in India_** _by leveraging local opportunities and overseeing all OTAU Clinical Science activities in India. Be accountable for speed and quality in collaboration with the global OTAU team and if appropriate OTAU-China, OTAU-Japan and other global R&D functions._ + **_Partner with ISEA and India LOC leaders_** _to enhance enterprise-level efforts for accelerating global clinical trials._ **_Accountabilities:_** **Lead India R&D Strategy and Execution** + Work closely with OTAU GPTs a and Global R&D functions to optimize integrated India development strategy for pipeline assets + Monitor overall country performance and support country focused oncology activities e.g. feasibility and site selections to deliver country operational milestones + Serve as the internal expert on India’s clinical development to inform global development strategy. Collaborate closely with India LOC to execute One Oncology strategy in India including tapping into local expertise and community networks + Collaborate and work closely with Oncology GPTs, the Global R&D team and regional teams, as appropriate, for each asset or indications under the remit + Engage study investigators to maintain strong interest and focus on Takeda’s oncology clinical trials + Proactively build and maintain strong investigator networks in India to support current and future trials across Takeda’s oncology portfolio in both solid tumors and hematologic malignancies and proactively share with the OTAU and Global teams + Build and scale global clinical trial capabilities in India as a key market in collaboration with LOC, Region and Global teams to accelerate Takeda innovation and boost efficiency **Clinical Development team participation and leadership** + Leads the Development Team in India for assigned compounds. In some cases may lead clinical directors or clinical scientist(s) responsible for leading this team with an emphasis on proactively identifying contingencies, risks, and mitigation strategies. + Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols in India. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical and constructive evaluation of the development strategy to maintain a state-of-the-art development 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 India specific decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global 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 in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need. **C. Synopsis / Protocol Development, Study Execution, & Study Interpretation** + _Leads Oncology Clinical Science activities in India, including protocol development, study execution, and data interpretation._ + _Serves as an advisor to the clinical scientists involved in these activities, and be accountable to senior company management for the successful completion of underlying objectives. For the assigned compounds, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals._ + _Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients._ **Trial Medical Monitoring** + _Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with_ _Pharmacovigilance._ **External Interactions** + _Leads KOL and investigator engagement strategies to support development of assigned compounds, and contributes to regulatory strategy in India_ + _Provides leadership and serves as an advisor to the other clinical physicians and scientists engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives in India._ **Due Diligence, Business Development and Alliance Projects** + _Can be assigned to be responsible for identification and evaluation of potential business development opportunities, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, as assigned. As part of a global due diligence team, assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with BD teams_ + _As assigned, serves as clinical point of contact for ongoing alliance projects and interfaces with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Provides guidance to clinical scientists who are involved in some of these activities._ **Leadership, Task Force Participation, Upper Management Accountability** + _Interacts directly with research division based on pertinent clinical and development expertise and with NPP to provide_ _knowledge/understanding_ _of India market environment. Represents clinical science on high impact/priority task forces across the organization or external to the company._ + _While currently an individual contributor position, the position may evolve or progress to be responsible in hiring, managing, mentoring, motivating, empowering, developing and retaining staff members to support assigned activities. Drives performance management, career development, and team engagement_ **Lead** **India** **Oncology Clinical Science team** + _Build, manage/overs_ _ee_ _and engage the_ _OTAU members in India_ + _Foster a high-performing team culture with a focus on development, well-being, and alignment with OTAU’s mission_ **Serving as Country Matter Expert** + _Be a strong advocate for the Takeda ONE Oncology and R&D organizations in_ _India_ _in collaboration with_ _India_ _LOC; serve as local bridge for any future opportunities in engaging_ _India_ _innovation ecosystem_ + _Point for escalation for resolution of complex country related issues & risk and serve as a site escalation point for oncology investigator concerns_ + **Lead and develop oncology clinical strategies for India according to business needs as assigned** **_Education & Competencies:_** **Education, Experience, Knowledge and Skills:** + _MD, combined MD/PhD or internationally recognized equivalent_ + _Clinical Training in Malignant Hematology and/or Medical Oncology preferred_ + _Minimum 3 to 5 years of clinical research experience in the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)._ + _Minimum of 4 to 5 years of people management experience in a healthcare or life sciences setting is preferred._ + _Proven success in leading global or regional clinical development teams, including responsibility for multi-regional studies. Experience beyond US/EU is a plus._ + _Experience with NDA/MAA Submission preferred_ + _Experience and expertise in clinical trial management and support of marketing authorization in India as required._ + _Demonstrated ability to lead and manage cross-functional medical, scientific and technical teams_ **Skills** + _Superior communication, strategic, interpersonal and negotiating skills_ + _Ability to anticipate challenges and drive proactive problem-solving_ + _Ability to drive decision-making within matrixed multi-regional teams_ + _Diplomacy and positive influencing abilities across diverse cultures_ + _Solid teamwork, organizational, interpersonal, and problem-solving skills; exercises good judgment with respect to Takeda confidential information and strategies_ + _Fluent business English (oral and written) and strong medical writing capabilities_ **Knowledge** + _Deep understanding of oncology therapeutic areas, including mechanisms of action relevant to assigned compounds._ + _Strong knowledge of global regulatory and compliance requirements, including but not limited to ICH GCP; awareness of local country requirements is essential._ + _Familiarity with emerging research trends in designated therapeutic area_ **TRAVEL REQUIREMENTS:** + _Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required._ + _Requires approximately 15 - 25% travel._ **Locations** Mumbai, India **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time