Medical Lead – Clinical & Medical Affairs
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time
Experience: Typically 5+ Years (Clinical Practice + Pharmacovigilance / Clinical Trials)
Qualification: MD (Medical Degree Mandatory)
Salary Range: Not Specified
Job Overview
Alvotech is seeking a Medical Lead – Clinical & Medical Affairs to provide medical oversight across clinical development programs and post-marketing activities.
The role involves ensuring patient safety, supporting pharmacovigilance activities, and contributing to clinical development strategies across the product lifecycle. The Medical Lead will work closely with cross-functional teams including pharmacovigilance, clinical development, and regulatory functions.
This position has a strong focus on post-marketing safety, including medical review of safety data, signal detection, and benefit-risk assessment, while also supporting clinical trial activities.
Key Responsibilities
Medical Oversight & Clinical Leadership
Provide medical input across the entire product lifecycle.
Work closely with cross-functional clinical and project teams.
Act as medical monitor for clinical trials including outsourced studies.
Provide medical interpretation of clinical data and study outcomes.
Pharmacovigilance & Drug Safety
Perform medical review of Individual Case Safety Reports (ICSRs).
Lead and contribute to signal detection and evaluation activities.
Review aggregate safety reports and benefit–risk assessments.
Collaborate with pharmacovigilance teams to ensure patient safety.
Clinical Trial Support
Contribute to development and review of essential clinical trial documents.
Support clinical trial activities in collaboration with Clinical Development Lead (CDL).
Ensure medical oversight of ongoing clinical studies.
Support CRO-managed and sponsor-led clinical trials.
Regulatory & Compliance
Support interactions with regulatory authorities when required.
Ensure compliance with global regulatory standards including GCP and GVP.
Adhere to ICH and other applicable regulatory guidelines.
Scientific Contribution
Contribute to and review scientific publications.
Provide medical insights to support clinical and regulatory documentation.
Participate in knowledge sharing within clinical and medical teams.
Required Skills
Medical & Clinical Expertise
Strong clinical background with experience in patient care.
Experience in pharmacovigilance and drug safety activities.
Ability to interpret clinical data and safety signals.
Pharmacovigilance Knowledge
Hands-on experience in ICSR review, signal detection, and risk assessment.
Understanding of post-marketing safety requirements.
Knowledge of benefit-risk evaluation processes.
Regulatory Knowledge
Strong knowledge of GCP, GVP, and ICH guidelines.
Experience supporting regulatory interactions.
Understanding of global clinical and safety regulations.
Communication & Collaboration
Strong communication and interpersonal skills.
Experience working in cross-functional and multicultural teams.
Ability to collaborate with clinical, regulatory, and safety teams.
Preferred Qualifications
Experience working as a Medical Lead in clinical trials.
Experience in biosimilar clinical development programs.
Experience working in CRO or pharmaceutical organizations.
Background in general medicine or internal medicine preferred.
Key Competencies
Clinical trial medical oversight and safety monitoring
Pharmacovigilance and risk assessment
Post-marketing surveillance and signal detection
Regulatory compliance (GCP, GVP, ICH)
Cross-functional collaboration in clinical development
Scientific review and medical communication
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused on the development and manufacturing of high-quality biosimilar medicines.
The company’s Integrated Clinical and Medical Research (iCMR) department within R&D drives clinical strategies aligned with biosimilar guidelines and global regulatory requirements, supporting both clinical development and post-marketing activities worldwide.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | 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) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
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Tuscaloosa |D.C :
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Germany | GErmany |Lower Saxony :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Amsterdam |North Brabant :
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Haarlem |South Holland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | Australia | Richmond Hill | Renfrew | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
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 :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya | Yavne |Remote :
Switzerland | Faridabad | Thailand | Minnesota | Lousiana | Remote | Lenexa | Remote - Africa | Springville | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Victoria | Manipal | Nairobi | Ireland | Remote - South America (Latin Americal) | French | Texas | Tulsa | Bishop | Green Way | Xzagreb | McFarland | Bountiful | Hungary | Leinster | Zaragoza | Blue Bell | Riga | Castlebar | Belgium | Slovakia | Hammond | Medan | Remote - Europe | Melbourne | Remote, USA |Republic of Colombia :
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Ciudad de México | New Mexico |Dubai :
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Rabigh | King Abdullah Economic City | Jeddah | Riyadh | Najran | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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