Clinical Development Manager
Clinical Development Manager
Posted on :
03-03-2025
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1 Vacancy
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Job Description
Job Title: Clinical Development Manager
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 Clinical Development Manager is primarily responsible for supporting departmental activities including but not limited to clinical trials (phase 1 to phase 4) conducting targeted scientific analyses for projects across therapeutic areas for nonclinical and clinical programs at Azurity. In this role the candidate will report to the Associate Director Clinical Development.
Principle Responsibilities
This should specifically outline in bullet form the responsibilities of the job:
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 Clinical Development Manager is primarily responsible for supporting departmental activities including but not limited to clinical trials (phase 1 to phase 4) conducting targeted scientific analyses for projects across therapeutic areas for nonclinical and clinical programs at Azurity. In this role the candidate will report to the Associate Director Clinical Development.
Principle Responsibilities
This should specifically outline in bullet form the responsibilities of the job:
- Ability to understand integrated data (formulation pharmacokinetics/genomics pharmacodynamics pharmacovigilance etc.) from clinical trials treatment guidelines and other resources to provide scientific evaluations and develop risk assessments.
- Provides operational and scientific oversight of nonclinical and clinical studies from study design to study closeout ensuring GCP/ICH/regulatory compliance of study documents processes and procedures.
- Author study documents including protocols consents management plans amendments etc.
- Review of CRO/3rd party documents (e.g. SOPs CRFs EDC TFLs etc.) to ensure alignment with Azurity’s quality expectations and SOPs if needed.
- Drafting responses to competent authorities or ethical committees.
- Vendor and site monitoring.
- Identify logistical/scientific/ethical/regulatory hurdles/risks and propose solutions.
- Provide clinical updates on assigned programs.
- Identify key scientific sources/findings to support clinical development contributions to regulatory communications (e.g. meeting requests briefing books IND/NDA submissions annual reports etc.)
- Identify KOLs external experts/consultants across diverse therapeutic areas to contribute to clinical development objectives.
- Draft abstracts posters oral presentations and manuscripts.
- Contribute to process improvement initiatives within clinical development or in collaboration with other functions.
- Facilitate contractual requirements (CDAs MSAs etc.) for clinical development projects in collaboration with applicable Azurity functions.
- Collaborate with PM function to ensure visibility of project deliverables.
This section should include relevant qualifications and education requirements.
- Degree in scientific/lifesciences field Master’s degree preferred.
- 3 years of experience in clinical development or related role within the pharmaceutical biotechnology or CRO industry.
- Working knowledge of clinical research GCP GLP ICH and FDA regulations.
- Understanding of pharmaceutical drug lifecycle preferred.
- Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely.
- Exceptional analytical and problemsolving skills.
- Experience in analysis of research data and publications.
- Demonstrates passion for research and willingness to learn.
- Brings innovation and creativity to challenging projects.
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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