Disease Area Specialist, Clinical Trial & Pipeline
Location: Mumbai, Maharashtra, India
Company: Bristol Myers Squibb (BMS)
Department: Medical Affairs / Clinical Development
Position Summary
The Disease Area Specialist (DAS) serves as a key medical and scientific leader responsible for driving pipeline strategy, clinical development activities, and medical initiatives within assigned therapeutic areas. The role acts as a trusted scientific partner, delivering high-impact medical insights, supporting clinical trial execution, and contributing to the successful development and adoption of innovative therapies.
This Head Office-based position requires close collaboration with Medical Affairs, Clinical Development, Regional Clinical Operations (RCO), Regulatory Affairs, Market Access, Commercial, and external healthcare stakeholders. Approximately 20–30% of the role involves field engagement with investigators, Key Opinion Leaders (KOLs), and clinical research sites.
Key Responsibilities
Medical Strategy and Pipeline Leadership
Align country medical activities with global and regional pipeline strategies.
Lead the medical strategy for assigned pipeline assets and therapeutic areas.
Participate in Early Product Planning (EPP) activities and represent the country in regional and global pipeline working groups.
Monitor competitive landscapes, emerging clinical data, and treatment trends to shape local medical and development strategies.
Translate global pipeline insights into localized medical plans based on patient needs, epidemiology, and healthcare system dynamics.
Clinical Development and Trial Leadership
Provide strategic and tactical medical leadership for Phase I–III clinical trials.
Contribute to clinical development plans, concept sheets, protocol reviews, and feasibility assessments.
Lead country-level feasibility evaluations by assessing:
Disease epidemiology
Patient journey
Treatment landscape
Competitive environment
Healthcare infrastructure
Payer and reimbursement considerations
Collaborate with Regional Clinical Operations teams to support study startup, recruitment planning, and trial execution.
Identify potential operational risks and implement mitigation strategies to maintain study timelines.
Investigator and Site Support
Serve as the primary medical contact for investigators and research sites.
Provide scientific and medical guidance throughout trial conduct.
Support protocol training and disease-area education for:
Clinical Research Associates (CRAs)
Clinical Study Executives (CSEs)
Investigators
Site personnel
Participate in investigator meetings, scientific conferences, and study-related educational activities.
Support trial recruitment and site engagement initiatives.
Medical Affairs and Scientific Engagement
Build and maintain strong relationships with Key Opinion Leaders (KOLs), researchers, and healthcare professionals.
Facilitate scientific exchange and gather actionable insights to support clinical development strategies.
Communicate emerging scientific evidence and clinical data to internal and external stakeholders.
Support the development of scientific advocacy within therapeutic areas.
Regulatory and Compliance Support
Provide medical input for:
Clinical Trial Applications (CTA)
NDA submissions
Label discussions
Regulatory agency meetings
Ministry of Health interactions
Post-approval commitments
Support interactions with:
Ethics Committees (IEC)
Institutional Review Boards (IRB)
Regulatory authorities
Ensure compliance with:
ICH-GCP Guidelines
Local regulatory requirements
Company policies and procedures
Safety and Pharmacovigilance
Conduct local review of Adverse Events (AEs) and Serious Adverse Events (SAEs) for development compounds.
Collaborate with Patient Safety teams on medical assessments and follow-up activities.
Provide medical expertise for:
Risk-benefit assessments
Safety evaluations
Pharmacovigilance activities
Audit and Inspection Readiness
Support internal audits and regulatory inspections.
Ensure trial activities comply with Good Clinical Practice (GCP) standards.
Participate in inspection preparation and remediation activities when required.
Cross-Functional Collaboration
Collaborate closely with:
Market Access
HEOR (Health Economics and Outcomes Research)
Regulatory Affairs
Commercial Teams
Payer Engagement Teams
Clinical Operations
Provide medical input for regulatory submissions, market access strategies, and evidence generation activities.
Utilize Real-World Evidence (RWE), registries, and epidemiological data to support clinical and commercial objectives.
Training and Scientific Development
Provide ongoing scientific training and education to:
Medical Science Liaisons (MSLs)
Medical Affairs Teams
Sales Teams
Marketing Teams
Mentor new team members and support capability development initiatives.
Maintain expertise through continuous scientific and medical education.
Qualifications
Education
Preferred:
MBBS
MD
Equivalent Medical Degree
Additional qualifications in Clinical Research, Medical Affairs, or Pharmaceutical Medicine are advantageous.
Experience
3–4 years of experience in:
Medical Affairs
Clinical Development
Clinical Research
Pharmaceutical Industry
Experience supporting clinical trials and pipeline assets preferred.
Exposure to multiple therapeutic areas is advantageous.
Experience engaging with healthcare professionals, investigators, and regulatory stakeholders.
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 :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
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 :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
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) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
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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 | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
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 :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
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 :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
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 :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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 :
Australia | Richmond Hill | North York | Uxbridge | Mississauga | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |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 :
Hà Nội | Hanoi |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 :
Yavne | Be'Er Sheva | Tel Aviv | Kfar Saba | Netanya |Remote :
McFarland | Faridabad | Perth | Xzagreb | Remote - South America (Latin Americal) | Springville | Remote - Africa | Bountiful | Manipal | Nairobi | Hungary | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Remote - Europe | Leinster | Minnesota | Belgium | Hammond | Riga | Zaragoza | Slovakia | Blue Bell | French | Tulsa | Texas | Lousiana | Medan | Ireland | Lenexa | Castlebar | Switzerland | Victoria | Melbourne | Thailand | Milwaukee | Bishop | Green Way |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Jeddah | Rabigh | Najran | Khulais | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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