Position Summary
The Senior Clinical Development Study Lead (Sr. CDSL) is a physician-led role responsible for providing medical and scientific leadership for one or more clinical studies across the drug development lifecycle.
The Sr. CDSL serves as the primary source of medical accountability for assigned studies and leads a cross-functional Study Team to ensure successful study design, execution, monitoring, analysis, and regulatory support. The role requires close collaboration with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, Medical Affairs, and external stakeholders.
Key Responsibilities
Clinical Development Leadership
Provide Clinical Development leadership for assigned clinical studies.
Lead cross-functional Study Teams across multiple functions.
Ensure alignment of study objectives with overall asset and project strategy.
Drive study execution from protocol development through study completion.
Medical Monitoring & Scientific Oversight
Serve as the primary medical lead for one or more clinical trials.
Perform or oversee:
Medical monitoring
Safety review
Clinical data review
Benefit-risk assessment
Interpret emerging clinical data and recommend actions.
Clinical Trial Design & Execution
Develop scientifically robust study designs.
Ensure studies meet:
Regulatory requirements
Business objectives
Commercial needs
Lead:
Protocol development
Study execution plans
Data review and analysis
Clinical study reporting
Project & Study Team Leadership
Lead multidisciplinary study teams comprising:
Clinical Operations
Regulatory Affairs
Biostatistics
Pharmacovigilance
Clinical Pharmacology
Data Management
Quality Assurance
CMC
Foster collaboration and efficient decision-making.
Drive accountability across functional teams.
Risk Management
Identify study risks proactively.
Develop and implement mitigation strategies.
Monitor study progress and performance.
Escalate critical issues to project leadership.
Regulatory Support
Support interactions with:
US FDA
EMA
Other Global Regulatory Authorities
Data Monitoring Committees
Prepare:
Regulatory documents
Clinical summaries
Presentations
Data packages
External Stakeholder Engagement
Act as Study Team spokesperson.
Participate in:
Investigator Meetings
Advisory Boards
Scientific Discussions
Key Opinion Leader (KOL) Interactions
Collaborate with:
Medical Affairs
Commercial Teams
External Advisors
Data Analysis & Reporting
Lead interpretation of study results.
Review efficacy and safety outcomes.
Support publication and presentation strategies.
Drive preparation of:
Clinical Study Reports (CSRs)
Regulatory submissions
Scientific presentations
People & Culture
Promote continuous improvement and innovation.
Support team development and mentoring.
Foster a culture of inclusion, accountability, and excellence.
Required Qualifications
Education
Mandatory
MD
MD + DM
MD/PhD
Experience
Required
Minimum 4+ years of pharmaceutical or biotechnology industry experience.
Experience in Clinical Development and Clinical Research.
Experience leading clinical studies.
Preferred
Experience across multiple phases of drug development (Phase I–IV).
Experience managing global clinical trials.
Experience interacting with regulatory authorities.
Technical Competencies
Clinical Development
Clinical Trial Design
Protocol Development
Medical Monitoring
Clinical Data Interpretation
Drug Development Strategy
Regulatory Knowledge
ICH Guidelines
Good Clinical Practice (GCP)
US FDA Regulations
EMA Regulations
Global Drug Development Requirements
Scientific Expertise
Therapeutic Area Knowledge
Clinical Safety Evaluation
Benefit-Risk Assessment
Regulatory Documentation
Leadership Competencies
Leadership & Influence
Lead in matrix organizations.
Influence stakeholders without direct authority.
Build high-performing study teams.
Strategic Thinking
Align study execution with asset strategy.
Support business and development objectives.
Decision Making
Evaluate complex clinical data.
Make informed scientific and operational decisions.
Communication
Present to executive leadership.
Communicate with regulators and external experts.
Drive consensus across multidisciplinary teams.
Problem Solving
Navigate complex clinical development challenges.
Develop innovative solutions under tight timelines.
Travel Requirement
Travel as required for:
Investigator meetings
Regulatory meetings
Internal governance reviews
Scientific conferences
Career Progression
Potential future roles include:
Associate Director, Clinical Development
Director, Clinical Development
Global Clinical Program Lead
Medical Director
Senior Medical Director
Vice President, Clinical Development
Uttar Pradesh :
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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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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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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 :
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 :
North York | Australia | Mississauga | Uxbridge | Richmond Hill | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |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 :
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) :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Sweden |Taipei :
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