Senior General Manager, Clinical Affairs

{
  "content_hash": "8537a8f3244a4628cd7f3f627d7591d94c85a9b145bb4dfc7f35a441349a3a7c",
  "source_hash": "33915b35b3a1537c6f15016a600f1be87c5724d4ce0761effba26536e7a792ac",
  "last_changed_at": "2026-06-06T11:07:11.678Z",
  "active_status": "active"
}

{
  "language": "en",
  "location": {
    "raw": "Shapath, Ahmedabad, Gujarat, IN",
    "city": "Gujarat",
    "region": "IN",
    "country": "United States",
    "is_remote": false,
    "confidence": 0.9
  },
  "salary_max": null,
  "salary_min": null,
  "inferred_at": "2026-06-06T20:23:04.060Z",
  "launch_scope": {
    "reason": "english_us_canada",
    "included": true,
    "language": "en",
    "location": {
      "raw": "Shapath, Ahmedabad, Gujarat, IN",
      "city": "Gujarat",
      "region": "IN",
      "country": "United States",
      "is_remote": false,
      "confidence": 0.9
    },
    "countries": [
      "United States"
    ]
  },
  "remote_policy": null,
  "salary_period": null,
  "workplace_type": "on_site",
  "salary_currency": null
}

{}

{
  "detail": {
    "Id": "7779",
    "Title": "Senior General Manager, Clinical Affairs",
    "media": [],
    "skills": [],
    "JobType": null,
    "Category": "Medical Affairs",
    "JobGrade": null,
    "JobLevel": null,
    "JobShift": null,
    "WorkDays": null,
    "WorkHours": null,
    "WorkYears": null,
    "Department": null,
    "HotJobFlag": false,
    "StudyLevel": "Master's Degree",
    "WorkMonths": null,
    "WorkerType": null,
    "GeographyId": 300000074184362,
    "JobFamilyId": 300000139874013,
    "JobFunction": "Regulatory & Clinical Affairs",
    "JobSchedule": "Full time",
    "BusinessUnit": null,
    "ContractType": null,
    "Organization": null,
    "TrendingFlag": true,
    "workLocation": [
      {
        "Country": "IN",
        "Region1": null,
        "Region2": "Gujarat",
        "Region3": null,
        "Building": null,
        "Latitude": "23.02213",
        "Longitude": "72.52506",
        "LocationId": 300000116226110,
        "PostalCode": "380015",
        "TownOrCity": "Ahmedabad",
        "AddressLine1": "Shapath-V, Near Hotel Crown Plaza",
        "AddressLine2": "12th Floor & 18th Floor, S.G. Highway",
        "AddressLine3": null,
        "AddressLine4": null,
        "LocationName": "Shapath"
      }
    ],
    "ContentLocale": "en",
    "HiringManager": null,
    "LegalEmployer": null,
    "RequisitionId": 300000231778046,
    "WorkplaceType": "On-site",
    "BusinessUnitId": 100000000147208,
    "OrganizationId": 100000000147208,
    "GeographyNodeId": 100000310315545,
    "JobFunctionCode": "RACA",
    "LegalEmployerId": 300000008253178,
    "PrimaryLocation": "Ahmedabad City, Gujarat, India",
    "RequisitionType": "India - Regular",
    "NumberOfOpenings": null,
    "WorkplaceTypeCode": "ORA_ON_SITE",
    "BeFirstToApplyFlag": false,
    "otherWorkLocations": [],
    "secondaryLocations": [],
    "ExternalContactName": null,
    "ShortDescriptionStr": "To lead the clinical development strategy for New Chemical Entities (NCEs) across global markets. This role is responsible for designing and overseeing clinical programs, ensuring regulatory compliance, and driving successful execution of clinical trials. The role will act as a key decision-maker in clinical strategy, regulatory interactions, and cross-functional collaboration to accelerate NCE development.",
    "ExternalContactEmail": null,
    "ExternalPostedEndDate": "2026-06-14T18:30:00+00:00",
    "OtherRequisitionTitle": null,
    "requisitionFlexFields": [],
    "ApplyWhenNotPostedFlag": true,
    "DomesticTravelRequired": null,
    "ExternalDescriptionStr": "<p><strong>Key Accountabilities</strong></p><p>•To deliver robust clinical strategies and trial execution for NCEs globally.<br>•To ensure compliance with international and local regulatory standards.<br>•To provide leadership in clinical decision-making and cross-functional collaboration.<br>•To drive timely completion of clinical milestones to support regulatory filings.</p><p><strong>Description:</strong></p><p><strong>Clinical Development Strategy</strong><br>• Define and lead global clinical development strategies for NCEs, ensuring alignment with regulatory pathways and business objectives.<br>•Provide scientific and strategic input for clinical trial design, endpoints, and overall development plans.<br>&nbsp;</p><p><strong>Clinical Trial Oversight</strong><br>•Oversee planning and execution of Phase I–IV clinical trials, including protocol development, site selection, and operational delivery.<br>•Ensure trials meet timelines, budget, and quality standards while maintaining patient safety and data integrity.<br>&nbsp;</p><p><strong>Regulatory &amp; Compliance</strong><br>•Collaborate with Regulatory Affairs for IND/NDA submissions and respond to health authority queries.<br>•Ensure adherence to ICH-GCP, local regulations, and ethical standards across all clinical activities.</p><p><br><strong>Cross-functional Collaboration</strong><br>•Partner with R&amp;D, Medical Affairs, Pharmacovigilance, and Commercial teams to integrate clinical insights into product development and lifecycle management.<br>•Provide clinical expertise for labelling, risk management, and market access strategies.</p><p><br><strong>Vendor &amp; Stakeholder Management</strong><br>•Manage relationships with CROs, investigators, and external partners to ensure high-quality trial execution.<br>•Negotiate contracts and monitor vendor performance for compliance and efficiency.<br>&nbsp;</p><p><strong>Leadership &amp; Team Development</strong><br>•Build and mentor a strong clinical team, fostering innovation and operational excellence.<br>•Drive organizational capability in clinical research through training and best practices.</p>",
    "ObjectVerNumberProfile": "1",
    "PrimaryLocationCountry": "IN",
    "CorporateDescriptionStr": "<span>Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.</span>",
    "ExternalPostedStartDate": "2026-05-28T12:04:11+00:00",
    "ExternalQualificationsStr": "<p><strong>Education &amp; Experience:</strong></p><p><strong>•&nbsp;</strong>Minimum 18–20 years of progressive experience in clinical development within the pharmaceutical or biotech industry.<br>• Proven track record of leading global clinical programs for New Chemical Entities (NCEs), including Phase I–IV trials.<br>• Strong experience in strategic planning and execution of clinical development plans aligned with regulatory requirements.<br>• Hands-on experience in liaison with regulatory authorities (CDSCO, USFDA, EMA) and supporting IND/NDA submissions.<br>• Demonstrated expertise in vendor/CRO management, clinical operations, and risk mitigation strategies.<br>• Exposure to global markets and multi-country clinical trial management.<br>• Leadership experience in building and mentoring large clinical teams and driving cross-functional collaboration.</p>",
    "InternalQualificationsStr": "<p><strong>Education &amp; Experience:</strong></p><p><strong>•&nbsp;</strong>Minimum 18–20 years of progressive experience in clinical development within the pharmaceutical or biotech industry.<br>• Proven track record of leading global clinical programs for New Chemical Entities (NCEs), including Phase I–IV trials.<br>• Strong experience in strategic planning and execution of clinical development plans aligned with regulatory requirements.<br>• Hands-on experience in liaison with regulatory authorities (CDSCO, USFDA, EMA) and supporting IND/NDA submissions.<br>• Demonstrated expertise in vendor/CRO management, clinical operations, and risk mitigation strategies.<br>• Exposure to global markets and multi-country clinical trial management.<br>• Leadership experience in building and mentoring large clinical teams and driving cross-functional collaboration.</p>",
    "OrganizationDescriptionStr": "<body> \n <p class=\"MsoNormal\">The&nbsp;<b>Human Resources team</b>&nbsp;partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.</p> \n <p class=\"MsoNormal\">&nbsp;</p> \n <p class=\"MsoNormal\">Key roles that the Human Resources team performs:</p> \n <p class=\"MsoNormal\">&nbsp;</p> \n <p class=\"MsoNormal\">Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.</p> \n <p class=\"MsoNormal\">&nbsp;</p> \n <p class=\"MsoNormal\">Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.</p> \n <p class=\"MsoNormal\">&nbsp;</p> \n <p class=\"MsoNormal\">Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.</p> \n <p class=\"MsoNormal\">&nbsp;</p> \n <p class=\"MsoNormal\">Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.</p> \n <p class=\"MsoNormal\">&nbsp;</p> \n <p class=\"MsoNormal\">Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.</p> \n <div> \n  <br /> \n </div> \n</body>",
    "primaryLocationCoordinates": [
      {
        "Latitude": "23.24082",
        "Longitude": "72.63733",
        "CountryCode": "IN",
        "GeographyId": 300000074184362,
        "GeographyNodeId": 100000310315545
      }
    ],
    "ExternalResponsibilitiesStr": "",
    "InternalResponsibilitiesStr": "",
    "InternationalTravelRequired": null
  },
  "list_job": {
    "Id": "7779",
    "Title": "Senior General Manager, Clinical Affairs",
    "JobType": null,
    "Distance": 1779926400000,
    "JobShift": null,
    "Language": "US",
    "WorkDays": null,
    "JobFamily": null,
    "Relevancy": 5,
    "WorkHours": null,
    "Department": null,
    "HotJobFlag": false,
    "PostedDate": "2026-05-28",
    "StudyLevel": null,
    "WorkerType": null,
    "GeographyId": 300000074184362,
    "JobFunction": null,
    "JobSchedule": null,
    "BusinessUnit": null,
    "ContractType": null,
    "ManagerLevel": null,
    "Organization": null,
    "TrendingFlag": true,
    "workLocation": [
      {
        "Country": "IN",
        "Region1": null,
        "Region2": "Gujarat",
        "Region3": null,
        "Building": null,
        "Latitude": 23.02213,
        "Longitude": 72.52506,
        "LocationId": 300000116226110,
        "PostalCode": "380015",
        "TownOrCity": "Ahmedabad",
        "AddressLine1": "Shapath-V, Near Hotel Crown Plaza",
        "AddressLine2": "12th Floor & 18th Floor, S.G. Highway",
        "AddressLine3": null,
        "AddressLine4": null,
        "LocationName": "Shapath"
      }
    ],
    "LegalEmployer": null,
    "MediaThumbURL": null,
    "WorkplaceType": "On-site",
    "BusinessUnitId": 100000000147208,
    "OrganizationId": 100000000147208,
    "PostingEndDate": null,
    "LegalEmployerId": 300000008253178,
    "PrimaryLocation": "Ahmedabad City, Gujarat, India",
    "WorkDurationYears": null,
    "WorkplaceTypeCode": "ORA_ON_SITE",
    "BeFirstToApplyFlag": false,
    "WorkDurationMonths": null,
    "otherWorkLocations": [],
    "secondaryLocations": [],
    "ShortDescriptionStr": "To lead the clinical development strategy for New Chemical Entities (NCEs) across global markets. This role is responsible for designing and overseeing clinical programs, ensuring regulatory compliance, and driving successful execution of clinical trials. The role will act as a key decision-maker in clinical strategy, regulatory interactions, and cross-functional collaboration to accelerate NCE development.",
    "requisitionFlexFields": [],
    "DomesticTravelRequired": null,
    "PrimaryLocationCountry": "IN",
    "ExternalQualificationsStr": null,
    "ExternalResponsibilitiesStr": null,
    "InternationalTravelRequired": null
  },
  "detail_meta": {
    "url": "https://hcfa.fa.us2.oraclecloud.com/hcmRestApi/resources/latest/recruitingCEJobRequisitionDetails?expand=all&onlyData=true&finder=ById;Id=%227779%22,siteNumber=CX_5001",
    "http_status": 200,
    "content_type": "application/json",
    "response_bytes": 9486
  },
  "detail_errors": []
}