12 Clinical Director jobs in India

Our client, a respected organization in the Community & Social Care sector, is seeking an experienced and compassionate Clinical Services Director. This fully remote position offers the flexibility to lead from anywhere while making a profound impact on community well-being. You will be responsible for the strategic planning, development, and management of all clinical services, ensuring the highest standards of care are met. This includes overseeing program implementation, managing clinical staff, ensuring regulatory compliance, and fostering collaborative relationships with stakeholders and community partners. The ideal candidate will possess a strong clinical background, extensive experience in leadership roles within healthcare or social services, and a deep understanding of community needs and best practices in care delivery. Proven ability in strategic planning, financial management, and program evaluation is essential. Excellent communication, interpersonal, and leadership skills are required to effectively manage a distributed team and engage with diverse populations. Experience with grant writing and reporting, as well as familiarity with relevant health and social care legislation, is highly desirable. This role offers a unique opportunity to shape the future of community care and drive positive social outcomes. You will be instrumental in expanding access to vital services and ensuring the highest quality of support for individuals and families. This is a leadership role that requires a visionary and dedicated individual committed to improving lives. This exciting remote opportunity, with a focus on services in Coimbatore, Tamil Nadu, IN , allows you to lead impactful initiatives from the comfort of your home.

Our client, a leading provider of community-based healthcare services, is seeking an experienced and visionary Clinical Services Director to lead their operations in Mumbai, Maharashtra, IN . This senior leadership position requires a comprehensive understanding of healthcare delivery models, patient care standards, regulatory compliance, and team management within a social care context. The Director will be responsible for ensuring the highest quality of clinical services, fostering operational excellence, and driving strategic growth initiatives.

Responsibilities:

• Oversee the strategic planning, development, and execution of all clinical services within the organization, ensuring alignment with mission and objectives.
• Lead, mentor, and manage a multidisciplinary team of healthcare professionals, including doctors, nurses, therapists, and support staff.
• Ensure the delivery of high-quality, patient-centered care, adhering to best practices and clinical protocols.
• Develop and implement policies and procedures to ensure compliance with all relevant healthcare regulations, accreditations, and quality standards.
• Manage operational budgets, resource allocation, and financial performance for clinical services, identifying opportunities for efficiency and cost-effectiveness.
• Drive quality improvement initiatives, patient safety programs, and outcome measurement strategies.
• Foster strong relationships with patients, families, community partners, and regulatory bodies.
• Represent the organization in professional forums and engage in advocacy for community healthcare services.
• Oversee the recruitment, training, and professional development of clinical staff, ensuring a skilled and motivated workforce.
• Manage departmental performance through effective monitoring of key performance indicators (KPIs) and implementation of corrective actions.

Qualifications:

• Master's degree in Healthcare Administration, Public Health, Nursing, or a related clinical field. A relevant doctoral degree is a plus.
• Minimum of 10 years of progressive leadership experience in clinical services management, preferably within community health, social care, or a related non-profit healthcare setting.
• Extensive knowledge of healthcare delivery systems, patient care models, and clinical best practices.
• Proven experience in managing budgets, operational efficiency, and quality improvement initiatives.
• Strong understanding of healthcare regulations, licensing, and accreditation standards.
• Exceptional leadership, communication, and interpersonal skills, with the ability to inspire and motivate diverse teams.
• Demonstrated ability in strategic planning, program development, and organizational management.
• Experience in stakeholder engagement and community relations.
• Proficiency in healthcare management software and data analysis.
• Passion for improving community health outcomes and serving vulnerable populations.

This role offers a significant opportunity to make a profound impact on community health and lead a dedicated team in delivering exceptional care.

Our client, a leading provider of community and social care services, is seeking a highly experienced and compassionate Clinical Operations Director to lead their specialized geriatric care division. This is a hybrid role, requiring a blend of on-site leadership within our facilities and strategic remote planning and coordination. You will be responsible for overseeing the delivery of high-quality, patient-centered care for elderly individuals, ensuring adherence to clinical best practices, regulatory standards, and operational efficiency. Your leadership will directly impact the well-being and quality of life for our residents and clients.

Key Responsibilities:

• Provide strategic leadership and operational management for all clinical services within the geriatric care division.
• Ensure the delivery of comprehensive and compassionate care, aligned with best practices in geriatrics.
• Develop, implement, and monitor clinical policies and procedures to ensure quality, safety, and compliance.
• Oversee the recruitment, training, and performance management of clinical staff, including nurses, therapists, and support personnel.
• Manage departmental budgets, resource allocation, and operational expenses.
• Collaborate with healthcare professionals, families, and community resources to ensure coordinated care plans.
• Monitor key performance indicators (KPIs) related to patient outcomes, satisfaction, and operational efficiency.
• Identify areas for service improvement and implement innovative strategies to enhance care delivery.
• Ensure compliance with all relevant healthcare regulations and accreditation standards.
• Champion a positive and supportive work environment for the clinical team.

Qualifications:

• Master's degree in Nursing, Healthcare Administration, Public Health, or a related clinical field.
• A minimum of 8 years of progressive experience in clinical leadership and healthcare management, with a significant focus on geriatric care.
• Extensive knowledge of geriatric health conditions, treatment modalities, and care management principles.
• Demonstrated experience in managing clinical operations, staff supervision, and budget oversight.
• Strong understanding of healthcare regulations, quality standards, and compliance requirements.
• Excellent leadership, communication, and interpersonal skills.
• Ability to thrive in a hybrid work environment, balancing hands-on leadership with remote strategic responsibilities.
• Proficiency in healthcare management software and EMR/EHR systems.
• Commitment to patient-centered care and continuous quality improvement.
• Relevant professional certifications are a plus.

This is a vital role within our organization, contributing to the health and well-being of the elderly community in Lucknow, Uttar Pradesh, IN . If you are a dedicated and visionary leader in geriatric care, we encourage you to apply.

Our client, a renowned provider of community and social care services, is seeking an experienced and compassionate Clinical Services Director to lead their elderly care division in **Pune, Maharashtra, IN**. This senior leadership position is responsible for ensuring the delivery of high-quality, person-centered care to residents. You will oversee all clinical operations, including nursing care, therapeutic services, and resident well-being programs. The successful candidate will be instrumental in developing and implementing clinical policies and procedures that meet regulatory standards and best practices in geriatric care. You will lead a team of healthcare professionals, including nurses, therapists, and support staff, fostering a positive and professional work environment. Key responsibilities include managing the clinical budget, ensuring efficient resource allocation, and maintaining high standards of patient safety and infection control. You will collaborate with residents, their families, and external healthcare providers to develop individualized care plans and ensure continuity of care. This role requires a strong understanding of gerontology, palliative care, and contemporary approaches to elderly support. The ideal candidate will possess excellent leadership, communication, and problem-solving skills. A commitment to promoting the dignity and independence of older adults is paramount. A Master's degree in Nursing, Public Health, Healthcare Administration, or a related field is required, along with a minimum of 10 years of progressive experience in clinical management, with a significant focus on elderly care. Relevant professional registration and licenses are mandatory. This is an exceptional opportunity to make a profound difference in the lives of seniors within a supportive and reputable organization, based at our **Pune, Maharashtra, IN** facility.

**Director Clinical Data Management**
**Live**
**What You Will Do**
Let's do this. Let's change the world. The Amgen Global Clinical Data Management team is looking for an experienced Director to lead our data management team on the aspiration of optimizing and delivering an industry admired clinical evidence platform to deliver innovative medicines to patients with unmet medical needs.
The Director is accountable for leadership and oversight of the data management organization; ensuring operational excellence and consistency in clinical trial execution. They are accountable for building and developing a high performing internal data management team, as well as ensuring engagement and alignment of Amgen's strategy and priorities with the Functional Service Provider (FSP).
The Director is also part of the Global Study Operations (GSO) leadership team, accountable for the delivery of quality clinical trials through industry-leading execution of innovative processes, strong cross-functional partnerships, and best-use of clinical systems and analytics to guide site and study operations. The role will support acceleration of clinical programs and other continuous improvement efforts, applying innovative thinking in shaping future strategy.
Our Global Clinical Data Management Team:
The Global Clinical Data Management Team comprises approximately 50 people. The three Directors, as part of the wider GSO organization and reporting into the Executive Director, Global Study Operations, work together to meet the demands of an industry leading, fast paced, high throughput organization with a commitment to compliance, quality and standards.
Director Clinical Data Management role overview:
You will lead and manage Data Management (DM) teams within a specific DM operational business unit. The Director will set and drive forward the vision and strategy for DM as a member of the DM and GSO Leadership Team.
Responsibilities:
+ Oversight of a distinct DM operational unit (e.g. therapy area, cross-product area)
+ Recruiting, managing and developing staff
+ Global resource planning and assignments
+ Setting of functional goals and objectives
+ Creating and implementing GSO & DM strategies developing, reviewing, implementing and enforcing data standards
+ Ensuring DM processes/systems meet regulatory and business requirements
+ Be an active member of the Leadership Team to provide a foundation for GSO success
Key activities will include:
+ Team management including performance, coaching and development
+ Develop, review and implement policies, SOPs and associated documents affecting DM globally
+ Set vision, strategy and direction for DM group; develop annual goals and objectives
+ Accountable for and oversee DM FSP relationships; ensuring goals of product areas and systems groups can be met via the FSP
+ Define and maintain Service Level Agreements and Key Performance Indicators; including oversight of quality and CAPA management
+ Governance oversight -ensure visibility into performance of FSPs to the department
+ Sponsor, Lead and participate in cross functional working groups
+ Resource and budget management for global function Ensure adequate training and capability within area and be accountable for staff compliance with all DM processes
+ Vendor management (development of strategies, contract management, relationship management, etc)
+ Respond to audit/inspection findings
+ Be accountable for and oversee all study deliverables and submission activities for products within group
+ Ensure that status information on DM activities is available and is acted on as needed
**Win**
**What We Expect Of You**
We are all different, yet we all use our unique contributions to serve patients. The data management professional we seek is a collaborator with these qualifications.
Basic requirements:
+ **18 to 23** years of data management experience
Preferred Experience:
+ Master's degree or equivalent in life science, computer science, business administration or related discipline
+ 10+ years of extensive experience in data management in the Pharmaceutical or Biotech arena
+ 8+ years of experience in rare disease therapeutic area, in a leadership role
+ Broad experience of working in a global organization
+ Experience at or oversight of outside vendors (CRO's, central labs, imaging vendors, etc)
+ 8+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
+ Strategic and innovative thinker with experience of driving operational excellence
+ Excellent relationship building skills with the ability to influence and make business impact
+ Ability to work collaboratively cross functionally with ability to influence and drive decisions
+ Proven experience within oversight of clinical research suppliers
+ Project management
+ Previous experience in a global, matrix organization
+ Excellent organizational and interpersonal skills
+ Ability to anticipate and problem solve challenging issues

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

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:_** _Describe at the highest level the team where this job sits and how this role will contribute to the team's delivery of critical function._
+ Provides quality assurance oversight of the global and local clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU), and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness.
+ Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice.
+ Defines and implements a risk-based program audit strategy, ensuring the communication of significant quality and compliance risks to key stakeholders and Management, and ensuring appropriate and timely investigations and mitigations are in place
+ Leads the inspection readiness programs, the management of the inspection, and the response and follow-up activities. Ensures that inspection risks are well-communicated and mitigated for both sponsor and investigator site inspections.
**_Accountabilities:_** _Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 - 10 bulleted task statements should be identified._
+ Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned development program teams and leadership
+ Assume complex assignments on issues or studies where there is no precedent
+ Mentor and provide support to Manager level CPQ personnel, as needed
+ Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, clinical trial delivery, documents, databases, vendors, or internal systems in compliance with GCP and Takeda policies and procedures.
+ Assess the impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CPMQ management.
+ Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
+ Lead or assist with investigations into significant quality issues, scientific misconduct, and serious breaches of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
+ Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate and timely inspection responses and follow-up actions
+ Analyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation
+ Collaborate with Clinical Safety Quality Compliance team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs, Takeda sites, or functional groups.
+ Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
+ Participate in due diligence activities and process improvement initiatives as requested by management
**_Education & Competencies (Technical and Behavioral):_** _List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted._
+ BA/BS degree required; advanced degree preferred.
+ Minimum of 10 -15 years of experience in the pharmaceutical, biotechnology or related health care industry.
+ Minimum 12-15 years of GCP-related Quality Assurance or relevant clinical trial experience.
+ Recent experience in leading and hosting India Central Drugs Standard Control Organization (CDSCO) inspection and other health authority inspection experience with FDA, MHRA etc.
+ Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development
+ Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective action plans that mitigate risks to the company, patient safety and data integrity.
+ Collaborative team player proficient in stakeholder management, possessing a positive attitude, critical thinking skills, and the ability to swiftly identify creative solutions to complex problems
+ Strong technical writing skills; able to write quality positions, audit reports, and procedures.
+ Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
+ Strong judgment, project management, and decision-making skills; able to manage multiple projects and demanding timelines
+ Superior attention to detail and ability to analyze complex data
+ Able to travel to various meetings, inspections and/or audits, including overnight trips and international travel.
**Locations**
IND - Bengaluru
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time

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**
**_OBJECTIVES/PURPOSE_**
+ Lead study operational strategy and planning and oversee execution of clinical studies for the assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan (CDP).
+ In close collaboration with Clinical Operations Program Lead (COPL) and Clinical Study Manager (CSM):
+ Responsible for oversight of the execution of studies in the assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
+ Oversight of strategic CRO partners and/or other vendors to meet Takeda's obligations described in ICH-GCP and Takeda's business objectives.
+ Represent Clinical Operations to contribute to CDP by providing regional operational expertise and strategic, inputs including study feasibility, budget, and timeline for assigned clinical programs
**_ACCOUNTABILITIES_**
+ Accountable for developing regional operational strategy for assigned clinical studies.
+ Contribute to the translation of CDP into an optimal operational strategy and plan. Lead assessment of various scenarios operational for optimal execution of CDP.
+ Collaborate with key investigators to reflect feasible and realistic operational inputs to CDP and ensure timeline and quality of studies meet the needs of CDP.
+ Provide subject matter expertise and operational input into protocol synopsis and protocol, obtaining opinions in terms of study execution from key investigators, as appropriate.
+ Challenge study team to ensure that operational feasibility, inclusive of patient and site burden and that timelines meet the needs of CDP.
+ Validate budget and ensure impacts are adequately addressed.
+ Participate in site selection process, with a focus on providing country insights, and therapeutic expertise to ensure alignment between study execution plan and program strategy.
+ Responsible for clinical study budget planning and management, and accountable for external spending related to clinical study execution. Works closely with relevant stakeholders (strategic CRO partners, other vendors, CSM, COPL, and Program Management, Outsourcing, and Finance) to ensure the accuracy of budget spending on a regular basis.
+ Oversee strategic CRO partners and other vendors to ensure the overall operational execution and delivery of the assigned clinical studies in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversight includes but is not limited to:
+ Review and approval of key risk-based monitoring documents/plans, periodic review of outputs, decisions, and actions related to risk-based monitoring.
+ Documented review and monitoring of issues, risks and, decisions at the study level.
+ Support the identification of trends across sites and/or the study.
+ Review and provide clinical operations expertise into clinical documents related to the drug development process:
+ Creation and maintenance of clinical trial materials, such as Investigator Brochures, study synopsis & protocols, clinical study reports, etc.
+ Preparation of key regulatory meetings, as appropriate.
+ Collaborate with cross-functional counterparts and strategic CRO partners/other vendors to ensure inspection readiness and lead Clinical Operations aspects of inspection readiness activities and act as subject matter expert during regulatory inspections.
+ Actively seek new ways of working more efficiently to meet the needs of clinical development, such as cost-reduction, time-savings, efficiency, and quality.
+ Participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
+ Responsible for talent development, including training and mentoring less experienced staff.
+ Seek an efficient way to maximize operational excellence in the cross-regional collaboration (e.g. Japan & Asia) with innovative ideas.
**_CORE ELEMENTS RELATED TO THIS ROLE_**
**Program**
+ Provide operational expertise and strategic inputs to the development of CDP and lead assessment of various operational scenarios for optimal execution of CDP.
+ Recognized as a clinical operations expert by other functions and stakeholders across R&D.
**Organization**
+ Actively seek new ways of executing studies more efficiently to meet the needs of clinical development and encourage the function.
**Capability development**
+ In addition to the self-development, think about supporting the development of Clinical Operations staff by sharing knowledge and experience with them.
**_DIMENSIONS AND ASPECTS_**
**Technical/Functional (Line) Expertise**
+ Have sufficient knowledge of regulatory and compliance requirements and guidance for clinical development, assigned Therapeutic Areas (TAs), project governances, and working models and accurately assess the impact of these on the assigned TA and programs.
**Leadership**
+ Demonstrate ability to work across functions, regions, and cultures.
+ Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
+ Train and develop less experienced staff with an awareness of mid- to long-term function goals and clinical development.
**Interaction**
+ Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
+ Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
**Innovation**
+ Recommend and influence the ideal model and approach for meeting the program goals and TA operational strategies.
+ Challenge status quo and bring forward innovative solutions.
**Complexity**
+ Work in global ecosystem (internal and external) with a high degree of complexity.
**Decision-making and Autonomy**
+ Provide input and implement appropriate strategies with understanding the goals of the function and assigned TA.
**_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_**
+ Bachelor's Degree or international equivalent required, Life Sciences preferred.
+ Innovate and challenge peers and teams to think and work differently; Work independently, excel at solving issues without the need for support, but is effective at enlisting support for specific asks when necessary.
+ Participate and lead clinical operations in cross-functional initiatives and workstreams that affect clinical operations; Adapt ways of working to the function's current state and formulate strategic plans to work within the existing framework.
+ Capable of assessing gaps cross-functionally and can take a supportive role in leading changes that benefits the function as it related to clinical trial execution and study management.
+ Encourage and provide input, suggestions, and support for competency building within the organization.
+ Demonstrated excellence in study management, including scenario assessment, risk assessment and contingency planning.
+ Excellent teamwork, communication, organizational, interpersonal, conflict resolution and problem-solving skills.
+ Talent development skills to enhance capabilities.
+ Experience of 10+ years in pharmaceutical industry and/or clinical research organization, including 7+ years of clinical study management/oversight.
+ Experience must include Phase 1, 2, 3 studies and global/international studies or programs.
+ Experience in more than one therapeutic area.
+ English (fluently in oral and written communication)
+ Local language (fluently, a native level)
**TRAVEL REQUIREMENTS:**
+ Requires approximately 5-20 % travel, including overnight and local/international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
**Locations**
IND - Bengaluru
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time

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**
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Medical Director, Clinical Science - Oncology in our Mumbai office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-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.
**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, as 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 OTAU R&D Strategy and Execution**
+ Work closely with OTAU GPTs 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 oncology clinical development environment to inform global development strategy. Collaborate closely with India LOC to execute Enterprise Engagement model 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 (US, EU, Japan) 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. 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.
**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**
+ 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.
+ Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Drives performance management, career development, and team engagement.
**Lead India Oncology Clinical Science team**
+ Build, manage/oversee and engage the India R&D members.
+ 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 assigne **d**
**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 aforementioned).
+ Minimum of 4 to 5 years of people management experience in a healthcare or life sciences setting.
+ 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.
+ Demonstrated ability to lead and manage cross-functional medical, scientific and technical teams.
+ 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
+ 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.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
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**Locations**
Mumbai, India
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time