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Job Details

Location
Bangalore
Salary
Competitive salary with benefits
Job Type
Permanent
Ref
BH-159187
Contact
Joanne Koo
Contact email
Email Joanne
Contact phone
65 6692 0751
Posted
3 months ago
Head of Clinical Development Operations
  • Team lead role
  • Based in Bangalore, India
Our client is an innovation-led global biopharmaceuticals company, committed in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally.
 
PURPOSE
  • Good understanding of Bio-pharmaceutical business-the big picture, how and what recent medical innovations and technological advances mean for Clinical Development and Operations goals and targets
  • Participate as a key member of the Clinical Development and Medical affairs leadership group to plan and utilize financial resources required to support development operations functions and teams, clinical trials, external collaborations and consultants
  • Provide leadership to all Clinical Operations groups, Clinical Quality and compliance, Pharmacovigilance and Bio-statistics functions and facilitate interactions with key stakeholders and key opinion leaders/investigators/experts
  • Build clinical development operations for future via optimal management of resources, hiring of key talent, expertise and developing, retaining critical talent
 
JOB RESPONSIBILITIES
 
Clinical Development - Clinical Operations
  • Provide leadership and direction in managing and driving the Company’s clinical development programs through all Phases of clinical trials in accordance with global standards – Regulations, Good Clinical Practice (GCP) and compliance, hands-on experience of clinical trials’ conduct in US, EU, Japan and/or other countries/regions
  • Guide clinical development operations groups and team members with trial design inputs, execution of all clinical studies within timelines and budget, preparation and review of clinical study documents such as Clinical Study Protocol, Trial Plans, Clinical Study reports and others
  • Interact with national and international regulatory agencies and is responsible for incorporation of regulatory authority advice feedback in clinical trials
  • Lead clinical development operations team during Clinical strategic as well as clinical operations discussions with alliance partners and governance committee(s), both for overall Clinical Program and specific Clinical Study
  • Motivate, mentor, guide and support clinical development operations groups and team members to elevate their performance to global standards, this includes ability to propose country/regional mix, approximate sample size, forecast budgets and timelines based on early Clinical Development Plans
  • Evaluate and incorporate newer technologies which enhance efficiency in execution and delivery of clinical trials
  • Contribute to Life-cycle Management of Products via scientific and operational inputs, including new or additional indications of already approved/existing Products
 
Clinical Quality and Compliance
  • Provide leadership to Clinical Quality, Training and Compliance group and members, ensure high quality across Clinical Development and operations, including review of quality plans, existing procedures, recommend and implement new procedures and systems to ensure efficient conduct of clinical trials, with continuous improvement being key focus
  • Manage Clinical Trials and Clinical Systems audits and inspections, this includes Inspections from USFDA, EMA and other leading regulatory authorities
  • Evaluation and risk assessment of Information technology and systems, software, tools used by Clinical Development Operations, including improvements, changes, validations, support yearly inspections
 
Bio-statistics and Clinical Data Management
  • Lead and manage Bio-statistics and Clinical data management personnel, ensuring strong input and delivery into all Product Clinical Development Plans and Clinical Trials
  • Ensure delivery of key trial plans and milestones (Data Management Plan, Statistical analysis Plan, DSMB management, Preparation for any Interim Trial analyses, Database lock, Clinical Trial Protocol and Study report inputs, etc) to high standards in compliance with requirements
 
Pharmacovigilance
  • Provide leadership to Pharmacovigilance group and members with high focus on ensuring regulatory compliance, both for Products in development and approved/marketed Products in different countries and regions across the world
  • Evaluate current practices and lead any required changes in existing practices and procedures, recommend/implement new procedures and systems/technology to ensure efficient Pharmacovigilance operations
 
Leadership competencies
  • Strong communication skills, with ability to inspire large team, ensures commitment from all to achieve challenging goals
  • Identifies and prioritizes alternative options based on what is commercially feasible
  • Builds strong collaborative relationships with stakeholders across the organization to enable timely decision making
  • Generates ideas or options for new systems or finds creative ways to modify and improve the existing systems
  • Understands and seamlessly drives change and organizational priorities
 
REQUIREMENTS
  • MBBS, MD/PhD (preferably) with 15 plus years of global clinical development and clinical operations leadership experience, Multi-national company experience is desirable
  • Demonstrated Strategic leadership and Operational excellence in planning and implementing Clinical development and Clinical operational plans with a portfolio of compounds in all phases of trials and with multiple therapeutic areas, experience in Oncology, Diabetes, Immunology clinical trials is desirable
  • Experience of working with global CROs and other vendors, with robust Sponsor oversight, including selection of CROs/vendors, managing high budgets/negotiation for global clinical trials (Phase I-IV, multi-country studies)
  • Directly handled multiple functions and personnel of Clinical Development, including Clinical Operations, Clinical Quality, Training and compliance, Clinical Safety, Bio-statistics and Clinical Data management, with good Operational understating of all areas 
  • Experience in leading and building large Clinical development and operations department and groups, including organization design, hiring and development of talent pool
  • Experience in working in collaboration with partners desirable, including managing national and international collaborations, via outsourced work
  • Has handled Clinical Trials as well as Clinical systems audits, national and international regulatory authority inspections, been involved in third party due diligence
  • Good understanding of global regulatory requirements for registration of new biologics, especially Bio-similars, new products/formulations, and active contribution, participation in regulatory authority meetings
  • Should be able to drive strategic initiatives around patient centricity, developing technology driven patient ecosystems, digitalization and analytics, data driven solutions to improve metrics for performance of clinical trials.


Reg No. R1109555
EBC Connect Pte Ltd
Licence no. 17C8975