Manager
Manager
Posted on :
05-02-2025
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1 Vacancy
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Job Description
Job Title: Manager (Clinical Development)
Job Location: Hyderabad Telangana India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
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 highquality medications Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust latestage pipeline. The company’s patientcentric products span the cardiovascular neurology endocrinology gastrointestinal institutional and orphan markets and have benefited millions of patients. For more information visit
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
This section should include relevant qualifications and education 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.
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 followup and communication with CROs. (* This involves travelling to the CRO locations and study sites.)
- Can independently perform noncompartmental PK analysis PK (or PBPK) modeling and IVIVC (preferable); communicate trial status and data to crossfunctional 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.
This section should include relevant qualifications and education requirements.
- Master’s Pharm.D or Ph.D degree preferred in the field of clinical research or equivalent field pharmacology pharmaceutics.
- Minimum of 6 years of pharmaceutical industry experience with at least 45 years of experience in Phase 1 (or 2) clinical development preferred.
- Sound understanding of US and exUS regulatory clinical requirements and experience of working in 505.b.2 pathwaybased drug development continuum with thorough knowledge of regulatory approval processes.
- Knowledge in ICH guidelines and GCP; experience of clinical trial designing and methodologies utilized in clinical pharmacology studies.
- Experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics.
- Have proven track record of working on Winnonlin or other PK software for noncompartmentalbased analysis steadystate simulations compartmental models and their utilities for dose and regimen finding.
- Strong organizational interpersonal and both verbal and written communication skills and ability to work collaboratively as a member of a crossfunctional team.
- Exceptional analytical and problemsolving skills.
- Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely.
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 handheld devices
- Other miscellaneous job duties as required
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Employment Type
Full Time
Key Skills
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