Clinical Development Leader
Descrição da Vaga
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,** who wants to learn and transform his career. **In this role you will** * Collaborate with physicians, scientists, statisticians, regulatory teams, operational leaders, and executive stakeholders in a complex matrix environment to design and execute **phase 1–3 interventional clinical trials** . * Ensure high‑quality protocol development aligned with the Clinical Development Plan to assess efficacy, safety, differentiation factors, and patient value efficiently. * Contribute medical expertise across the **end‑to‑end lifecycle** of clinical trials (protocol concept → final study report), ensuring scientific integrity and regulatory alignment. * Interpret and summarize study outcomes, including efficacy, safety, pharmacokinetics/pharmacodynamics, and patient‑reported outcomes, ensuring applicability to the target patient population. * Provide real‑time medical monitoring for ongoing studies, including patient eligibility assessments, study design guidance, and responses to urgent safety questions (in partnership with Safety/PV teams as appropriate). * Lead or oversee the medical review of clinical trial data, including blinded data packages for IDMC submissions. * Review and monitor safety data in collaboration with pharmacovigilance for active clinical studies. * Participate in the development of clinical study reports and regulatory submission documents, collaborating cross‑functionally (Regulatory Affairs, CMC, Toxicology, Research, Pharmacology) to address health authority and ethics committee queries. * Partner with Principal Investigators to evaluate abstracts, posters, and manuscripts related to clinical trial results. * Build long‑term partnerships with internal and external thought leaders to support the strategic direction of the oncology portfolio. * Demonstrate strong understanding of disease biology, clinical strategy, and scientific literature related to oncology targets. * Serve as a core member of the **Clinical Matrix Team** for one or more pipeline assets. * Represent Clinical Development in cross‑functional strategic discussions, including disease area strategy, integrated evidence planning, and medical affairs strategy. * Participate in Oncology Clinical Development–wide initiatives, workstreams, and strategic programs. **Mandatory Skills** * Fluent English (verbal and written). * Medical Doctor (MD) with valid license to practice medicine. * **3\+ years of experience** in the pharmaceutical/biotechnology industry or related clinical practice. * Documented academic research, clinical publications, or relevant medical practice in oncology or related fields. * Strong working knowledge of clinical drug development with direct experience in **phase 1–3 clinical trials** (investigator‑initiated, company‑sponsored, or cooperative group trials). * Familiarity with regulatory requirements for drug registration and adherence to **Good Clinical Practice (GCP)** . **\<\<\<\< 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!*
Vaga originalmente publicada em: linkedin
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