Senior Medical Director - Clinical Science, Oncology

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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/oversee 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 5 to 7 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.

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