Director, Clinical Operations
Location
Secunderabad | India
Job description
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 .
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.
Job Description Summary The Director, Clinical Operations, Phase 1 – India provides support through expertise and guidance of applicable regulatory, Good Clinical Practice (GCP), and Standard Operating Procedure (SOP) requirements for the conduct of Phase 1 clinical studies sponsored by Azurity.
Representing Azurity Clinical Development, the role facilitates initiation, conduct, reporting, and closure of Phase 1 clinical investigations conducted at Contract Research Organizations (CRO) in India. 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 Phase 1 studies.
- Manages performance of CROs and other vendors contracted to provide services on clinical studies.
- Ensures conduct of clinical study complies with study protocol requirements, identifies areas of concern, and enacts contingences when appropriate.
- Develop study plan(s) including key milestones and timelines.
- Leads study team and drives projects to alignment across stakeholder functions.
- Manage critical study documents, such as consent forms, study manuals, subject recruitment materials.
- Responsible for ensuring GCP adherence and study monitoring are established for each clinical investigation.
- Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF.
- Drive critical clinical trial activities including trial site activations, recruitment, and database lock.
- Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting.
- Partner with program manager and study team members to develop study level plans and goals and ensure alignment with overall development plan.
- Propose alternative study operation strategies to optimise use of time cost and resource.
- Review monitoring reports and, if applicable, corrective action plans at individual sites and provide oversight to ensure safety concerns are identified and responses developed.
- 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 clinical requirements.
- Knowledge in ICH guidelines and GCP.
- Experience in analysis of research data and publications; working 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.
- 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
Job tags
Salary
