Clinical Director

At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, fast and always on target, we are Adalvo.
SUMMARY OF POSITION

The Clinical Director plays a strategic and hands-on leadership role within Adalvo's Clinical Operations & Development (COD) function, with direct responsibility for the planning, execution, and oversight of clinical studies. This position ensures that all clinical activities meet regulatory requirements, adhere to Good Clinical Practice (GCP), and align with Adalvo's business goals.
Responsibilities:
• Leadership & Team Development:
• Assign Clinical Project Managers (CPMs) to each study managed by the COD team in India.
• Ensure all team members receive induction and ongoing training in GCP, SOPs, and relevant clinical practices
• Develop and implement training plans for new and existing employees tailored to their roles and responsibilities.
• Foster a multiskilled, high-performing clinical team through structured training and mentorship.
• Clinical Strategy & Execution:
• Collaborate with Portfolio, Regulatory, and R&D functions to define clinical requirements, strategies, and feasibility plans.
• Oversee the end-to-end execution of a variety of clinical studies, including bioequivalence, pharmacokinetics, patient-based studies, and in-vitro assessments.
• Establish and execute the overall clinical development plan once assigned by management.
• Lead protocol development, study execution, and ensure alignment with submission plans and regulatory requirements.
• Operational Oversight:
• Manage internal resource planning, including back-up and cross-functional support.
• Ensure clinical studies are properly resourced, on-budget, and delivered on time to the highest quality standards.
• Lead IMP (Investigational Medicinal Product) management, including packaging, labelling, recall activities, and CAPAs.
• Vendor & CRO Management:
• Identify, evaluate, and manage relationships with CROs and other external vendors.
• Lead the negotiation and execution of CDAs, MSAs, supplier and service agreements.
• Oversee CRO qualification/requalification processes in coordination with Clinical Quality.
• Compliance & Quality:
• Ensure all clinical activities comply with GCP, GPvP, and Adalvo's internal SOPs.
• Confirm that safety reporting processes are defined and documented prior to subject screening.
• Investigate and manage suspected scientific misconduct and recommend appropriate actions, including CAPA or study termination.
• Monitoring & Reporting:
• Supervise the performance of CPMs to ensure compliance with clinical plans, study timelines, and regulatory documentation standards.
• Review clinical documentation, expert reports, study protocols, and registration modules.
• Oversee the proper setup and maintenance of Trial Master Files (TMF), ensuring compliance with regulatory and internal expectations.
• Cross-functional Collaboration:
• Coordinate with Legal, Finance, and Quality teams to align on study-related contracts and documentation.
• Support regulatory submissions with relevant clinical data and documentation as needed.
• Additional Responsibilities:
• Participate in scientific advice and justification preparation for study initiation.
• Review comparative dissolution profile (CDP) data and batch selection criteria with R&D.
• Travel as required to support global clinical operations and study oversight.
• Perform additional tasks as assigned by management.

Requirements:
• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field (PhD/MD preferred).
• Minimum 10 years of experience in clinical operations, with at least 5 years in a leadership role.
• Strong knowledge of GCP, ICH guidelines, and global clinical regulatory requirements.
• Proven experience in managing international clinical trials and CRO/vendor oversight.
• Exceptional project management, leadership, and communication skills.
• Ability to work cross-functionally in a fast-paced, matrixed environment.
• Strong problem-solving mindset with a proactive, solution-oriented approach.
Core Competencies:
• Business Focus
• Drive for Results
• Building Team Spirit
• Customer Service
• Embracing Change
• Quality