BUGWORKS Research
Website:
bugworksresearch.com
Job details:
Company Description Bugworks Research Inc. focuses on developing path-breaking solutions for major unmet needs in antimicrobial resistance (AMR) and immuno-oncology. The company is committed to creating highly differentiated therapeutic assets that are affordable and accessible globally. Bugworks combines advanced research with a mission-driven approach to improve patient outcomes and public health. Team members collaborate across scientific and operational disciplines to bring innovative treatments from concept to clinic.
Role Description The Senior Manager Clinical Operations is a full-time, on-site role based in Bengaluru. This position oversees the planning, execution, and monitoring of clinical trials to ensure they are conducted in compliance with protocols, regulations, and quality standards. The role includes leading and mentoring clinical research associates, coordinating with cross-functional teams, managing timelines, budgets, and vendor relationships, and resolving operational issues. The Senior Manager will review and approve study documents, track study metrics, support site selection and initiation, and ensure accurate documentation and reporting. This role also contributes to process improvement initiatives and provides strategic input into clinical development plans.
Trial Execution & Global Program Delivery (Phase 1–3)
- Lead operational planning, site selection, and execution of early-phase Clinical Research Unit (CRU) trials in healthy volunteers (FIH, SAD/MAD, DDI, BA/BE, Renal/Hepatic Impairment).
- Oversee multi-center regional and global Phase 1b, Phase 2, and Phase 3 trials in patient populations across oncology (dose expansion, RECIST 1.1 endpoints) and AMR (hospital ICUs, acute
- Successfully navigate unique operational environments from fast-paced early phase Phase 1 units to tertiary care hospital ICUs and global academic oncology hubs.
- Maintain executive-level oversight on operational deliverables, timelines, risk mitigation plans, and program budgets across all phase transitions.
- Select, negotiate, and drive accountability across global CROs, Phase 1 CRUs, specialty central labs, central imaging core labs, and microbiological labs.
- Ensure compliance with Indian regulatory frameworks (New Drugs and Clinical Trials Rules, CDSCO approval pathways, NDCT Form CT-06) and manage DGFT / customs export documentation for biological samples.
- Oversee trial-level budgets, negotiate contracts (CTA/FDF), evaluate scope modifications (Change Orders), and track program accruals.
- Maintain audit-ready eTMF standards and lead site/vendor preparation for regulatory authority inspections (FDA, EMA, CDSCO).
- Provide operational leadership for Safety Review Committees (SRC) and Independent Data Monitoring Committees (IDMC/DSMB).
- Ensure all studies comply with ICH-GCP guidelines, local regulatory frameworks (FDA, EMA, PMDA, etc.), and ethical standards for oncology patient management.
Qualifications
- Master’s or Bachelor’s degree in Life Sciences, Pharmacy (B.Pharm or M.Pharm), Nursing, or related discipline required. PharmD is preferred.
- 7 to 10 years of progressive clinical operations experience within biotech, pharma, or tier-1 CROs with proven team-working abilities.
- Direct experience executing both Healthy Volunteer Phase 1 studies and Phase 2/3 global patient trials.
- Proven operational track record in Oncology and/or AMR / Anti-Infectives / Acute Care.
- Deep knowledge of ICH-GCP guidelines, CDSCO regulations, and international regulatory requirements (FDA/EMA).
- Hands-on familiarity with Indian biological sample export permissions (CDSCO NOCs, DGFT licenses) and central lab chain-of-custody protocols.
- Strong Clinical Operations and Project Management skills to lead and oversee multiple clinical studies.
- Hands-on experience in Clinical Research and working with Clinical Research Associates to manage sites and study activities.
- Proven ability in Research, including interpreting clinical data and supporting evidence-based decision-making.
- Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Demonstrated leadership, team management, and stakeholder communication skills.
- Ability to work on-site in Bengaluru and collaborate effectively with multidisciplinary teams.
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