Head Clinical Development

  Regulatory Affairs

Job title: Head Clinical Development

Company: Abbott Nutrition Health Institute (ANHI)

Job description: Primary Function: Provides clinical development expertise to study teams, project teams and to the overall assigned in order to deliver state of the art clinical development programs and studies supporting clinical programs for EPD compounds in devel

Primary Function: Provides clinical development expertise to study teams, project teams and to the overall assigned in order to deliver state of the art clinical development programs and studies supporting clinical programs for EPD compounds in development to expand or maintain EPD compounds on the market. Ensures that all clinical development work for the compounds assigned is carried out in a timely manner with the required quality. Core Role Responsibilities: Responsibility for Clinical Studies/Development Programs: Leadership : Acts as the Global Clinical Head in a global project or product team with joint leadership of the clinical study team (CST) together with global statistician and clinical trial manager. Oversee the global studies/clinical development programs for products under his/her responsibility to ensure that the development is executed in line with international medical/scientific and quality standards and within timelines and budget in close cooperation with the clinical trial manager, supports regional or local studies/programs. Subject Matter Expert in Studies/Development Programs: Responsible for the preparation and review of clinical documents, including clinical development plans, scientific advice briefing documents, pediatric investigation plans ( if applicable), clinical study concepts, clinical study protocols, Investigator’s Brochures, clinical study reports, clinical modules of CTD, response documents for EC, MoH on the program. Take on role of safety physician for global clinical studies/programs. Responsible for the medical oversight during trials and functions as SME for scientific and medical questions during the trials. Review of safety review plan, SAE reconciliation, safety listings and coding during the trials/programs. Reviewing and approving of all clinical activities that are primarily lead by the clinical development group. Guide and advise on the analysis of the studies in the projects maintains an up-to-date repository of clinical information on projects, competitors, and the TA in general Contribute to statistical analysis plan, blind data review meetings, lead data interpretation meetings and medical writing activities. Support Budget forecasting and Tracking for clinical studies/clinical development programs Talent Management, mentoring. Shares best practices and insights: Support, guide, train the CRO team and internal teams in TAs, protocols and ensure complete understanding Interacts with opinion leaders to collect their input as needed for the clinical project Cross Functional Collaboration: . Subject Matter Expert – for Clinical Development strategy, pipeline and evaluations: Work as SME and support NSTs for new product development ideation and identify trends, clinical development strategy, clinical development plans as needed. Must keep abreast of development activities in TAs of interest and portfolio so as to support NSTs. Review and evaluate due diligences for clinical development program, deliver new ideas for product innovations. Preparing the clinical part of the therapeutic area target product profiles (TPP) in alignment with PT/NST Being on top of medical scientific knowledge, evaluating and reviewing medical literature, based on these providing potential new improved therapeutic benefit ideas to enhance and maximize potential benefit for disease management and patient care for the TA. Acquires and shares clinical medical expertise in the therapeutic area and on the competitive treatments to support Clinical Operations, Medical Services, Marketing, Licensing & Acquisitions and Training teams. Effective communication in the teams, with stakeholders and with individuals. Adhere to the goals and motivate the team and reports, deliver business results Anticipation of business risks from different angles on the products and programs and proactively addressing them Translate the clinical strategic TA goals into operational reality. Customer insight driven inspiration driving business Activities with PV: Support the Product Safety Team as needed with regard to assigned products. Lead safety monitoring within all clinical activities under his/her, oversee the medical review or development of white papers. Cooperate with Global PV on the development of e.g. RMPs, PSURs and ACOs Activities with RA/Health Authorities Responsible for the development and maintenance of CTD sections 2.5 and 2.7, ADR evaluation, defense the clinical part for the authority feedback, contribute to deficiency letters of authority requests regarding the clinical sections. Support the process of product-specific medical queries from the Health Authorities. Responsible for the development of integrated safety databases and/or integrated efficacy databases for the core products together with the biometrics department. Data mining of clinical studies data in order to provide new insights, e.g. global label extensions and publication of the output. Oversee the work of the Labeling Subteam Team(LST): provide medical evaluation and propose scientific strategies with regards to major national label change requests (including safety issues as requests for DDLs), with team responsible for global company scientific information (CCDS, Master SmPC Oversee clinical expert opinion for regulatory and safety documents, and medical assessments for QA related internal requests related to the products under responsibility Interacts with the Project Teams including Commercial, Regulatory Affairs, Medical Affairs and other disciplines to ensure that the clinical project fulfills the regulatory requirements and represents the company to the Regulatory bodies as appropriate on clinical matters. Supervisory/Management Responsibilities: Direct report-0 Indirect Report 1-2 Position Accountability/Scope: Accountable for the clinical development strategy and alignment with multidisciplinary project team objectives, informing key stakeholders and gaining support. Accountable for the design and delivery of clinical programs in accordance with international medical/scientific and quality standards and within timelines and budget. Accountable for the safety monitoring, medical oversight, reporting (leading to registration) and publication of clinical trials (phase II-IV, post marketing support). Accountable for providing in-depth clinical knowledge of the TA under consideration. Adequate people and stakeholder management, provides direction to achieve business objectives, efficiently delegate tasks and give clear guidance. Minimum Education: MD or PhD or MD/PhD Minimum Experience/Training Required: At least 10-15 years of experience in pharmaceutical industry with minimum of 5-8 years in relevant clinical development. Ability to lead clinical programs and to run teams in multi-cultural environment at different sites. Expert knowledge of clinical trial methodology, oversight/evaluation of safety and regulatory requirements governing clinical trials. Developmental and Medical Insights of Emerging markets. Works independently, takes responsibility, strong communication silks (written and oral) in English. Core competencies : Communication, Customer Service Orientation, Decision Making, Leadership, Strategic Thinking, Risk anticipation, People management, including resource allocation Functional competencies : Coaching and Consulting, Cross-Team Integration, Planning & Organizing

Expected salary:

Location: Mumbai, Maharashtra

Job date: Thu, 27 Jan 2022 23:01:01 GMT

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