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SUMMARY OF POSITION 

The successful candidate will help in the clinical development of 505(b)(2) products and complex generics. 

The candidate should be able to act as an independent clinical pharmacologist and will partner with formulation development, analytical chemistry, project management, and regulatory affairs to provide clinical strategies for internal and external R&D programs.

ORGANIZATION STRUCTURE

Reports to Senior Director, Clinical R&D and is based in Pine Brook, New Jersey.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• 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.

QUALIFICATIONS

• 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. Experience in CNS/Psychiatric therapeutics area (e.g., MDD, Schizophrenia, etc.) is preferred
• 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.

• The following traits are essential for success:

1. Proven strong leadership and management skills; can work across a portfolio with competing priorities,
2. Team player with proven flexibility; high degree of motivation,
3. Self-starter; can work with limited direction,
4. Strong analytical skills,
5. Strong hands-on, “roll up your sleeves” and “right first time” mentality,
6. Ability to think strategically and execute on strategy,

GMP DECISION-MAKING AUTHORITY

This position needs to follow SOPs and alert QA of risks that could impact product safety and efficacy.