BioSpace
Medical Director, Clinical Sciences - Immunology
Medical Director, Clinical Sciences - Immunology role at BioSpace, Cambridge office. This description reflects the responsibilities and qualifications for leading immunology-focused clinical development within Takeda’s PDT R&D unit as part of a global, multi-regional team. Overview / Objectives
The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda seeks to advance clinical development for immunodeficiency assets with input from medical, scientific, regulatory and commercial perspectives and to drive global development plans across regions. Accountabilities
Clinical Development: participate in and lead immunodeficiency clinical development for a given product or indication; may represent Clinical Science on the Global Clinical Development Team to align activities with global strategy. Development Strategy & Governance: establish and drive development strategy and deliverables, producing the Clinical Development Plan and Clinical Protocols; evaluate scope and budget; maintain a state-of-the-art plan and develop contingency plans to meet regulatory requirements. Global Decision-Making: monitor and interpret data from internal and external studies; make high-impact recommendations (e.g., go/no-go decisions, modifications to plans or study designs) that affect timelines and labeling. Study Design & Interpretation: lead immunodeficiency clinical science activities for synopses, protocols, and studies; advise associated medical directors; present study conclusions and determine impact on overall product strategy. Trial Medical Monitoring: oversee medical monitoring, safety assessments, and pharmacovigilance collaboration; ensure scientific integrity in study conduct. External Interactions: manage regulatory authorities interactions and engagement with key opinion leaders; provide leadership and advisory support to others in clinical development activities. Due Diligence & Alliances: identify and evaluate BD opportunities; conduct due diligence, develop clinical plans for alliances or in-licensing; serve as clinical contact for alliance projects and coordinate with partners to meet strategic goals. Leadership & People: collaborate across functions and regions; may lead cross-functional teams; hire, mentor, and develop staff; conduct performance reviews and development planning. Dimensions and Skills
Leadership: global perspective; ability to influence without authority; promote diversity and inclusion; agile leadership. Decision-making: decisive, data-driven; balance internal and external inputs; develop executable plans and manage budgets and deadlines. Interaction: strong communication, negotiation, and influencing skills; effective cross-stakeholder collaboration. Innovation: drive data-driven decision making; pursue process and systems improvements. Complexity: solve abstract problems across functions; clarify accountabilities in a global matrix environment; manage large-scale change. Education, Competencies And Skills
M.D. or internationally recognized equivalent required; advanced degree (e.g., Ph.D.) desired. Expertise in Immunology or related field; specialty certification desired. 3–5 years of clinical research/drug development experience in pharma; experience leading clinical development teams across regions preferred. Strong medical knowledge, publications, NDA/MAA submission experience preferred; regulatory knowledge (GCP/ICH) required; physician license or equivalent desired. Superior communication, strategic thinking, negotiation and interpersonal skills; ability to drive decision-making in multi-disciplinary, multi-regional teams. Knowledge of plasma-derived therapies and related disease mechanisms; regulatory requirements at regional/global levels; diplomacy and influencing abilities. Travel Requirements
Ability to drive or fly to meetings/sites; some international travel may be required; approximately 10–20% travel. Location & Employment Details
Location: Boston, MA (Hybrid/Remote work policy applies). Worker Type: Employee; Full-time; Exempt: Yes. Compensation & Benefits
Salary range for U.S. base:
$228,200.00 – $358,600.00 . The actual offer depends on qualifications, experience, and location. Benefits may include medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, volunteer time off, paid holidays, sick time, and vacation accrual where applicable. EEO Statement
Takeda is committed to a diverse workforce and equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity or expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or veteran status, in accordance with applicable laws. Locations
Boston, MA Other job postings and related opportunities may be shown for context. Referrals increase your chances of interviewing at BioSpace. Get notified about new Medical Director jobs in Boston, MA.
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Medical Director, Clinical Sciences - Immunology role at BioSpace, Cambridge office. This description reflects the responsibilities and qualifications for leading immunology-focused clinical development within Takeda’s PDT R&D unit as part of a global, multi-regional team. Overview / Objectives
The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda seeks to advance clinical development for immunodeficiency assets with input from medical, scientific, regulatory and commercial perspectives and to drive global development plans across regions. Accountabilities
Clinical Development: participate in and lead immunodeficiency clinical development for a given product or indication; may represent Clinical Science on the Global Clinical Development Team to align activities with global strategy. Development Strategy & Governance: establish and drive development strategy and deliverables, producing the Clinical Development Plan and Clinical Protocols; evaluate scope and budget; maintain a state-of-the-art plan and develop contingency plans to meet regulatory requirements. Global Decision-Making: monitor and interpret data from internal and external studies; make high-impact recommendations (e.g., go/no-go decisions, modifications to plans or study designs) that affect timelines and labeling. Study Design & Interpretation: lead immunodeficiency clinical science activities for synopses, protocols, and studies; advise associated medical directors; present study conclusions and determine impact on overall product strategy. Trial Medical Monitoring: oversee medical monitoring, safety assessments, and pharmacovigilance collaboration; ensure scientific integrity in study conduct. External Interactions: manage regulatory authorities interactions and engagement with key opinion leaders; provide leadership and advisory support to others in clinical development activities. Due Diligence & Alliances: identify and evaluate BD opportunities; conduct due diligence, develop clinical plans for alliances or in-licensing; serve as clinical contact for alliance projects and coordinate with partners to meet strategic goals. Leadership & People: collaborate across functions and regions; may lead cross-functional teams; hire, mentor, and develop staff; conduct performance reviews and development planning. Dimensions and Skills
Leadership: global perspective; ability to influence without authority; promote diversity and inclusion; agile leadership. Decision-making: decisive, data-driven; balance internal and external inputs; develop executable plans and manage budgets and deadlines. Interaction: strong communication, negotiation, and influencing skills; effective cross-stakeholder collaboration. Innovation: drive data-driven decision making; pursue process and systems improvements. Complexity: solve abstract problems across functions; clarify accountabilities in a global matrix environment; manage large-scale change. Education, Competencies And Skills
M.D. or internationally recognized equivalent required; advanced degree (e.g., Ph.D.) desired. Expertise in Immunology or related field; specialty certification desired. 3–5 years of clinical research/drug development experience in pharma; experience leading clinical development teams across regions preferred. Strong medical knowledge, publications, NDA/MAA submission experience preferred; regulatory knowledge (GCP/ICH) required; physician license or equivalent desired. Superior communication, strategic thinking, negotiation and interpersonal skills; ability to drive decision-making in multi-disciplinary, multi-regional teams. Knowledge of plasma-derived therapies and related disease mechanisms; regulatory requirements at regional/global levels; diplomacy and influencing abilities. Travel Requirements
Ability to drive or fly to meetings/sites; some international travel may be required; approximately 10–20% travel. Location & Employment Details
Location: Boston, MA (Hybrid/Remote work policy applies). Worker Type: Employee; Full-time; Exempt: Yes. Compensation & Benefits
Salary range for U.S. base:
$228,200.00 – $358,600.00 . The actual offer depends on qualifications, experience, and location. Benefits may include medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, volunteer time off, paid holidays, sick time, and vacation accrual where applicable. EEO Statement
Takeda is committed to a diverse workforce and equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity or expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or veteran status, in accordance with applicable laws. Locations
Boston, MA Other job postings and related opportunities may be shown for context. Referrals increase your chances of interviewing at BioSpace. Get notified about new Medical Director jobs in Boston, MA.
#J-18808-Ljbffr