Clinical Development Leader

Come to one of the biggest IT Services companies in the world! Here you can transform your career! Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment. We are looking for a **Clinical Development Leader (Medical Monitor)** . **In this role you will:** This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents. **Responsibilities:** Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1\-3 interventional clinical trials * Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe. * Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making * Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population. * Assume medical responsibility for clinical trials with active participation in real\-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant). * Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee blinded review of data packages intended for IDMCs. * Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies. * Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries. * Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data. * Network extensively to develop long\-term strategic partnerships with thought leaders both internally and externally, in support of company’s vision. * Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target\-based literature. * Serve as a core member of the Clinical Matrix Team for one or more assets in development. * Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams. * Participate in Oncology Clinical Development\-wide initiatives and workstreams as appropriate. **We have some requirements:** * Fluent English * Licensure to practice medicine * 3\+ years of experience in pharmaceutical/biotechnology industry or related clinical experience * Documented academic and/or clinical research publication history or history of medical practice in a relevant field. * Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications. * Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles **\<\<\<\< Please attach resume in English\>\>\>\>\>\>** **What do we offer?** **TCS Benefits – Brazil:** * Health insurance * Dental Plan * Life insurance * Transportation vouchers * Meal/Food Voucher * Childcare assistance * Totalpass * TCS Cares – free 0800 that provides psychological assistance (24 hrs/day), legal, social and financial assistance to associates * Partnership with SESC * Reimbursement of Certifications * Free TCS Learning Portal – Online courses and live training * International experience opportunity * Discount Partnership with Universities and Language Schools * Bring Your Buddy – By referring people you become eligible to receive a bonus for each hire * TCS Gems – Recognition for performance * Xcelerate – Free Mentoring Career Platform * Tata Consultancy Services is an equal opportunity employer, our commitment to diversity \& inclusion drives our efforts to provide equal opportunity to all candidates who meet our required knowledge \& competency needs, irrespective of any socio\-economic background, race, color, national origin, religion, sex, gender identity/expression , age, marital status, disability, sexual orientation or any others. We encourage anyone interested to build a career in TCS to participate in our recruitment \& selection process. *At TATA Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA\+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer!* **\#Buildingonbelief**