Key Responsibilities
1. Clinical Study Design and Execution
Lead the design, planning, and implementation of clinical studies, particularly in areas requiring pharmacokinetic and pharmacology expertise.
Monitor and report the studies at CRO
Develop study protocols, investigator brochures, and other study-related documents in collaboration with cross-functional teams.
Manage timelines, budgets, and resources to ensure project deliverables are met within scope.
2. Specialty Pharma Expertise
Apply pharmacokinetics and pharmacology knowledge to optimize study designs for niche or complex therapeutic areas.
Support bioavailability, bioequivalence, and drug interaction studies to meet regulatory requirements for specialty pharma products.
Collaborate with formulation and regulatory teams to align clinical studies with product development goals.
3. Regulatory and Compliance Oversight
Ensure compliance with global regulatory standards (FDA, EMA, ICH-GCP) and local regulatory requirements.
Manage interactions with regulatory agencies, IRBs, and ethics committees.
4. Team Leadership and Project Management
Lead and mentor clinical research associates, coordinators, and other team members involved in clinical studies.
Timely execution of projects
Manager vendors, including CROs, labs, and other service providers, ensuring high-quality deliverables.
Foster collaboration among internal and external stakeholders to support study objectives.
5. Data Management and Analysis
Collaborate with data management teams to ensure accurate collection and analysis of clinical studies data.
Review and interpret clinical data, particularly pharmacokinetic and pharmacodynamic results, to assess drug safety and efficacy.
Provide scientific insights to inform regulatory filings, publications, and strategic decisions.
Qualifications
Educational Background:
Advanced degree (Masters, PharmD, or PhD) in Pharmacokinetics, Pharmacology, or a related field.
Experience:
5-8 years of clinical research experience, preferably in specialty pharma, with at least 2 years in a leadership role.
Demonstrated expertise in pharmacokinetics, including modelling, simulation, and interpretation of PK/PD data.
Experience in managing early-phase clinical studies, bioequivalence studies, or rare disease programs.
Technical Skills:
Strong knowledge of pharmacokinetic principles, drug metabolism, and specialty pharma therapeutic areas.
Proficiency in clinical trial software (e.g., Medidata, Trial Master File systems) and pharmacokinetic tools (e.g., NONMEM, WinNonlin).
Familiarity with regulatory submission processes for specialty pharmaceuticals.
Soft Skills:
Excellent leadership, project management, and problem-solving skills.
Strong communication skills for collaborating with cross-functional teams and presenting complex scientific data.
Detail-oriented and adaptable to the dynamic nature of specialty pharma development.
Preferred Qualifications
Certification in Clinical Research (e.g., SOCRA, ACRP).
Experience in rare diseases, oncology, or other specialty therapeutic areas.
Track record of regulatory interaction and successful trial submissions in specialty pharma