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 !

We are looking for a Clinical Director   to join our dynamic Adalvo team. This position offers an opportunity to well-suited candidates to join a growing, fast paced energetic environment and culture.

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. The Clinical Director will lead clinical strategy development, oversee clinical project managers (CPMs), manage vendor relationships, and drive excellence in clinical trial execution.

ORGANIZATION STRUCTURE

The position will report directly to our Deputy CEO & SVP, Strategic Scientific Affairs

RESPONSIBILITIES

Primary responsibilities of this role include the following:

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.
Organize annual development kick-off meetings in collaboration with Pharmacovigilance and Clinical Quality teams.

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.

KEY REQUIREMENTS

Advanced degree in Life…