Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit
www.azurity.com.Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.The Director, Clinical Science R&D – India is a role that integrates clinical knowledge into pharmaceutical formulation research to aid development activities for new formulations within the 505(b)(2) and ANDA space. The Director must have experience in early clinical development with demonstrable knowledge in pharmacokinetics (PK), design and analysis of clinical studies with specific of PK endpoints, comprehension of Regulatory/ICH guidance, and proficiency in Good Clinical Practice (GCP).Representing Azurity Clinical Development, the role is multifaceted and aids pharmaceutical formulation to ensure appropriate clinical input is provided at product prototyping and initiation of development activities.
The selected candidate should have a balance of both scientific and operational aspects of clinical research including facilitation of trial initiation, conduct, and reporting. Strong familiarity with Contract Research Organizations (CRO) in India required. Serves as primary point of contact for Azurity to CROs in India. The selected candidate will work with Azurity stakeholder functions within Product Development, Regulatory, Drug Safety, Program Management, and other key functions to enable oversight of clinical trial activities, and has input to optimize trial execution, coordinate governance interactions, and contribute to product development strategy. The candidate will report to the Vice President, Clinical Development.
Responsibilities:
- Accountable for delivery of high-quality clinical data from Azurity-sponsored early clinical studies.
- Design of early clinical studies to evaluate PK profiles of novel drug formulations.
- Interpretation of PK data to inform impact to candidate development and inform formulation team on potential modifications.
- Ability to assimilate results from PK analysis and safety to establish clinical bridge requirements for ANDA and 505(b)(2) drug candidates.
- Understanding of pharmaceutical formulation characteristics including in vitro and in vivo data interpretation, desired.
- Comprehension of in vitro in vivo correlation (IVIVC) and ability to provide insight into formulation development including identification of biorelevant media, desired.
- Experience across multiple drug formulation types including solid oral dosage forms, oral solutions, oral suspensions, delayed release, and injections.
- Management of CROs and other vendors contracted to provide services on clinical studies.
- Oversight of conduct of clinical studies ensuring compliance to study protocol requirements and identifies areas of concern enacting contingences when appropriate.
- Responsible for ensuring GCP adherence is established and maintained for each clinical investigation.
- Coordinates with Azurity clinical quality to ensure oversight of all clinical investigations.
- Partner with Delivery Captain, program manager, and other study team members to develop study level plans and goals and ensure alignment with overall development plan.
- Communicate trial status, issues, and mitigations to relevant cross-functional stakeholders.
- Contribute to the development, review, and approval of clinical study documents including but not limited to informed consent forms (ICF), investigator’s brochure (IB), study plans, eCRFs, pharmacy and laboratory manuals, clinical study reports, and regulatory documents (e.g., IND, NDA).
- Train study team members, external monitors, and site staff as needed.
Qualifications and Education Requirements
- Degree in scientific/life-sciences field such as Master’s, Pharm.D, or Ph.D degree preferred.
- Experience and/or Training: Minimum of 10 years of pharmaceutical industry experience; minimum of 5 years of clinical experience preferred.
- Sound understanding of US and ex-US Regulatory requirements.
- Knowledge in ICH guidance and GCP.
- Experience in analysis of research data and publications; strong knowledge of biostatistics and pharmacokinetics.
- Demonstrates passion for research, brings innovation to challenging projects, and possesses a willingness to learn and work across diverse therapeutic areas and modalities.
- Understanding of the drug development continuum with through knowledge of regulatory approval processes.
- Strong organizational, interpersonal and both verbal and written communication skills and ability to work collaboratively as a member of a cross-functional team.
- Exceptional analytical and problem-solving skills.
- Knowledge in WinNonlin or other PK analysis software beneficial.
- Ability to prioritize and multi-task to meet objectives in a fast-paced company environment.
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to sit for long periods of time
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
- May occasionally climb stairs and/or ride elevators
- The employee must occasionally lift and/or move up to 25 pounds
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
- Other miscellaneous job duties as required
