Global Clinical Development Manager
Company: Sandoz
Location: Telangana, India
Function: Research & Development
Employment Type: Full Time | Regular
Job Overview
The Global Clinical Development Manager (GCDM) is responsible for supporting and overseeing global clinical development activities across early and late-stage development programs. The role contributes to clinical development strategy, clinical trial design, protocol development, regulatory interactions, CRO oversight, safety monitoring, quality compliance, and publication planning.
Working closely with Global Program Medical Directors (GPMD), CROs, Regulatory Affairs, Clinical Operations, Safety, and Medical Affairs teams, the GCDM ensures successful execution of clinical development programs while maintaining compliance with global regulatory standards and scientific excellence.
Key Responsibilities
Clinical Development Strategy
Contribute to the overall clinical development strategy for assigned programs.
Support the development and execution of Clinical Development Plans (CDPs).
Participate in portfolio discussions and early development planning.
Provide scientific and medical expertise for development programs.
Clinical Trial Design & Protocol Development
Oversee development of Phase I, Phase II, Phase III, and adaptive clinical study protocols.
Ensure study designs align with:
Clinical Development Plans
Strategic Study Concepts
Regulatory Expectations
Scientific Best Practices
Review and approve protocol-related documentation generated by CROs.
Clinical Trial Oversight
Monitor clinical trial conduct and progress through CRO partnerships.
Ensure studies are delivered:
On Time
Within Budget
According to Quality Standards
Support joint clinical teams and may serve as Chair or Co-Chair when required.
Monitor key project milestones and study deliverables.
CRO Management
Provide medical and scientific oversight to CRO partners.
Review CRO processes, deliverables, and compliance standards.
Collaborate closely with CRO medical leads and operational teams.
Evaluate CRO performance and identify process improvement opportunities.
Safety & Pharmacovigilance Support
Support safety signal detection activities.
Collaborate with:
Safety Teams
Pharmacovigilance Teams
Medical Monitors
Contribute to preparation and review of:
DSURs (Development Safety Update Reports)
PSURs (Periodic Safety Update Reports)
Risk Management Plans (RMPs)
Review safety data and provide medical input when required.
Regulatory Affairs Support
Collaborate with Regulatory Affairs teams on submission strategies.
Support preparation of regulatory documentation.
Participate in:
Pre-IND Meetings
Health Authority Interactions
Regulatory Submission Activities
Represent the organization as a development expert when required.
Quality & Compliance
Collaborate with Clinical Quality Assurance teams.
Ensure compliance with:
ICH Guidelines
GCP Standards
Regulatory Requirements
Internal SOPs
Review and contribute to development of clinical development SOPs.
Conduct gap assessments and review CRO procedures.
Inspection Readiness
Support inspection readiness activities.
Assist teams in preparing for:
Regulatory Inspections
Sponsor Audits
Quality Reviews
Ensure clinical documentation and processes meet regulatory expectations.
Budget & Resource Management
Support project budget planning and monitoring.
Collaborate with Clinical Operations and Program Leadership on resource management.
Monitor project expenditures and timelines.
Medical Affairs & Publications
Support publication planning and scientific communication activities.
Collaborate with Medical Affairs teams on publication strategies.
Oversee clinical trial registry postings and study results disclosures.
Support dissemination of scientific findings.
Training & Mentorship
Participate in onboarding and training activities.
Mentor colleagues and share best practices.
Contribute to continuous improvement initiatives.
Support development of organizational capabilities.
Due Diligence & Portfolio Support
Support due diligence activities for licensing and acquisition opportunities.
Provide medical and scientific assessments when required.
Contribute to portfolio evaluation and strategic planning.
Qualifications
Education
MD (Doctor of Medicine) preferred.
Medical specialization relevant to therapeutic area is desirable.
Preferred Qualifications
MD with Clinical Research Experience.
Advanced Medical or Scientific Training.
Therapeutic Area Expertise.
Experience (Minimum Required)
Clinical Development Experience in:
Pharmaceutical Industry
Biotechnology Industry
CRO Environment
Experience across:
Early Development
Late-Stage Development
Clinical Trial Management
Knowledge of:
Clinical Research Methodology
Drug Development Process
Regulatory Requirements
Preferred Experience
CRO Oversight and Vendor Management.
Matrix Team Leadership.
Safety and Pharmacovigilance Support.
Regulatory Submission Support.
Global Clinical Development Programs.
People Management Experience.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
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Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Norway | NOrway |Romania :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Australia | Richmond Hill | Uxbridge | North York | Renfrew | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
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Peru | Argentina |Brazil :
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Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Saitama | Japan |Tokyo :
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Kyiv |Lima Region :
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Prague |Chile :
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