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.
Brief team/department description:
As part of the Clinical Development team at Azurity, the Manager, Clinical Development is a contributor to early development activities in support of product evaluation and testing across multiple therapeutic areas.In this role, the candidate will report to the Director, Clinical Development and work with stakeholders and team members to provide scientific excellence, build effective relationships across R&D, and ensure optimal design and analysis of clinical investigations.
Principle Responsibilities:
- Design studies including technical, regulatory and formulation aspects.
- Collaborate with respective program manager and study teams to develop study plans and ensure alignment with overall development plan, key milestones and timelines.
- Ensures compliance of clinical study with GCP, local and target regulatory guidelines, study protocol; identifies areas of concern, and enacts contingences when appropriate.
- Oversees study operations* including and not limited to study initiation, monitoring and closeout, sample shipment and routine follow-up and communication with CROs.
* This involves travelling to the CRO locations and study sites.
- Can independently perform non-compartmental PK analysis, PK (or PBPK) modeling and IVIVC (preferable); communicate trial status and data to cross-functional teams.
- Oversee data repository, TMF, other critical study documents, such as consent forms, study manuals, subject recruitment materials.
- Propose alternative study operation strategies to optimize use of time, cost and resource.
- Contribute to the development, review, and approval of clinical study documents including but not limited to ICF, investigator’s brochure (IB), study plans, CRFs, pharmacy and laboratory manuals, clinical study reports, and regulatory documents.
Qualifications and Education Requirements
- Master’s, Pharm.D, or PhD degree preferred in the field of clinical research or equivalent field, pharmacology, pharmaceutics.
- Minimum of 6 years of pharmaceutical industry experience with at least 4-5 years of experience in Phase 1 (or 2) clinical development preferred.
- Sound understanding of US and ex-US regulatory clinical requirements and understanding of the drug development continuum with thorough knowledge of regulatory approval processes.
- Knowledge in ICH guidelines and GCP.
- Experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics.
- 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.
- Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely.
By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
