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Alvogen · 13 hours ago

Associate Director Clinical Research & Develo

Pinebrook, TX

Full-time

Onsite

Lead/Staff, Director/Executive

10+ years exp

Alvogen is focused on the clinical development of 505(b)(2) products and complex generics. The successful candidate will act as an independent clinical pharmacologist, providing clinical strategies and collaborating with various departments to ensure successful execution of clinical studies.

Health CareManufacturingMedicalPharmaceutical

Responsibilities

Assess viability of 505(b)(2) and complex generics ideas from Clinical R&D perspective

Act as an independent clinical pharmacologist to identify required studies per the regulatory strategy, and to design and execute such studies

Responsible for providing clinical expertise pertaining to study design, planning and execution of Phase 1, Phase 2 or Phase 3 clinical studies

Ensures each project has a robust PK and clinical program and adheres to GCP, GLP and all applicable regulatory guidelines. Monitor changes/updates made to Guidance documents related to Clinical studies/BE studies and implementation thereof

Identify gaps in pre-clinical and Phase 1 DDP that could impact Phase 2/3 design and execution timelines for Alvogen internal projects as well as programs being evaluated as part of due diligence

Drafting of initial pediatric study plan (iPSP) and clinical sections of the regulatory submissions (eg. pIND, Type A/B/C/D meetings, NDA, etc.) for 505b(2) products

Partner with Regulatory Affairs for FDA meetings ensure successful execution of 505(b)(2) programs

Collaborate with R&D during product development to provide guidance on PK issues, developing biorelevant dissolution, PK modeling, simulations, WinNonlin, and IVIVC/IVIVR models

Collaborate extensively with Portfolio and Business Development and provide scientific feedback and clinical plans for identifying and developing new products through in-licensing or due diligence efforts

Works cross-functionally and with external partners to select clinical study designs to align with Company objectives; Works with Regulatory in filing of applications and responding to deficiencies

Qualification

Clinical pharmacologyClinical developmentPK modeling505(b)(2) productsGCP knowledgeRegulatory guidelinesCNS therapeuticsAnalytical skillsLeadership skillsCommunication skillsTeam player

Required

Ph.D in a scientific discipline with at least 10 years of experience in the conduct of PK, clinical end point, and Phase 2/3 studies

Experience in generic/specialty pharmaceutical companies on a variety of dosage forms, including inhalation, topical, and complex injectable products is required

Clinical development experience with 505b(2) products is required

Thorough knowledge and understanding of scientific principles applicable to product development and extensive experience in PK modeling, simulation, IVIVC/IVIVR to support product development

Extensive knowledge of clinical development, including thorough understanding of the clinical development phases, processes and techniques used to execute a clinical development program

Knowledge of GCP, GLP, ICH and regulatory guidelines is essential

Excellent written and verbal communications and interpersonal skills

Proven strong leadership and management skills; can work across a portfolio with competing priorities

Team player with proven flexibility; high degree of motivation

Self-starter; can work with limited direction

Strong analytical skills

Strong hands-on, 'roll up your sleeves' and 'right first time' mentality

Ability to think strategically and execute on strategy