Global Development Lead - Executive Medical Director (MD Required)

Tubulis•Boston, MA

14d•Hybrid

About The Position

The Global Development Lead (GDL) – Executive Medical Director is accountable for the end-to-end clinical development strategy and execution of one or more antibody–drug conjugate (ADC) programs in gynecologic malignancies and other solid tumors. The GDL Leads cross-functional teams to ensure alignment and integration between Pharmacovigilance, Translational, Regulatory, Medical Affairs, and Commercial functions. This role requires expertise in oncology drug development, a strong understanding of ADC-specific development challenges, and demonstrated scientific, medical, and clinical research expertise in gynecologic oncology. The Global Development Lead – Executive Medical Director reports to the Vice President of Clinical Development and has direct management responsibility for Medical Directors leading gynecologic oncology clinical programs. You will be part of a highly collaborative and cross-functional team involved with site evaluation, study start-up, study execution and management, and study close-out of our trials. This position will report to the VP, Clinical and Translational Development. The ideal candidate will be based in the Boston, MA region w ith remote opportunities available for candidates located in MA, NY, PA, RI, NJ, FL, or NC Your mission Program Strategy & Leadership Accountable for designing and implementing the Clinical Development (CD) strategy and plans in gynecologic oncology from first-in-human through registration. Lead and chair the Global Program Team (GPT), aligning Clinical Development, Translational Medicine, Regulatory Affairs, CMC, Safety, Biostatistics, Clinical Operations, Medical Affairs, and Commercial. Define clear program objectives, milestones, and decision criteria, balancing speed, differentiation, and risk. Ensure strategic coherence across indications, lines of therapy, combinations, and geographic regions. Drug Development Leadership Provides deep clinical expertise and scientific input into trials and portfolio decisions Integrate ADC-specific considerations into program strategy, including: Target biology and expression heterogeneity Payload mechanism, linker stability, and bystander effects Dose optimization and therapeutic index Safety and tolerability based on emerging data Collaborate cross functionally to ensure alignment between clinical strategy and CMC readiness, particularly for scale-up, comparability, and registrational supply. Clinical & Regulatory Development Work closely with Clinical Development leadership to ensure efficient execution of clinical studies, including meeting milestones. Collaborates to develop the global regulatory strategy, including FDA, EMA, and other health authority interactions (e.g., EOP meetings, scientific advice, accelerated approval pathways). define indication sequencing, trial design, endpoints, and comparator strategies in ovarian, endometrial, and cervical cancers. Lead biomarker-driven development strategies, including patient selection, enrichment approaches, and companion/complimentary diagnostic considerations. Oversees and participates in preparation of key program deliverables, including TPPs, integrated development plans, regulatory briefing documents, and governance materials. Governance & Decision Making Serve as the primary program representative to internal governance committees and executive leadership. Lead scenario planning, risk assessments, and data-driven go/no-go decisions, particularly at PoC and registrational transition points. Ensure timely escalation of issues with clear mitigation and contingency plans. Cross-Functional Execution Collaborate with program management to ensure integrated timelines, budgets, and resource planning across all functions. Ensure alignment of clinical, translational, regulatory, and CMC critical paths, especially for registrational studies. Mentors and coaches team members to foster a high-performing culture. External Engagement Support interactions with external partners, CROs, academic investigators, and key opinion leaders in gynecologic oncology. Represent the program in selected external forums, including advisory boards and major oncology congresses (e.g., ASCO, ESMO, SGO). Qualifications: Program Strategy & Leadership Accountable for designing and implementing the Clinical Development (CD) strategy and plans in gynecologic oncology from first-in-human through registration. Lead and chair the Global Program Team (GPT), aligning Clinical Development, Translational Medicine, Regulatory Affairs, CMC, Safety, Biostatistics, Clinical Operations, Medical Affairs, and Commercial. Define clear program objectives, milestones, and decision criteria, balancing speed, differentiation, and risk. Ensure strategic coherence across indications, lines of therapy, combinations, and geographic regions. Drug Development Leadership Provides deep clinical expertise and scientific input into trials and portfolio decisions Integrate ADC-specific considerations into program strategy, including: Target biology and expression heterogeneity Payload mechanism, linker stability, and bystander effects Dose optimization and therapeutic index Safety and tolerability based on emerging data Collaborate cross functionally to ensure alignment between clinical strategy and CMC readiness, particularly for scale-up, comparability, and registrational supply. Clinical & Regulatory Development Work closely with Clinical Development leadership to ensure efficient execution of clinical studies, including meeting milestones. Collaborates to develop the global regulatory strategy, including FDA, EMA, and other health authority interactions (e.g., EOP meetings, scientific advice, accelerated approval pathways). Define indication sequencing, trial design, endpoints, and comparator strategies in gynecological cancers and other solid tumors. Lead biomarker-driven development strategies, including patient selection, enrichment approaches, and companion/complimentary diagnostic considerations. Oversees and participates in preparation of key program deliverables, including TPPs, integrated development plans, regulatory briefing documents, and governance materials. Governance & Decision Making Serve as the primary program representative to internal governance committees and executive leadership. Lead scenario planning, risk assessments, and data-driven go/no-go decisions, particularly at PoC and registrational transition points. Ensure timely escalation of issues with clear mitigation and contingency plans. Cross-Functional Execution Collaborate with program management to ensure integrated timelines, budgets, and resource planning across all functions. Ensure alignment of clinical, translational, regulatory, and CMC critical paths, especially for registrational studies. Mentors and coaches team members to foster a high-performing culture. External Engagement Support interactions with external partners, CROs, academic investigators, and key opinion leaders in gynecologic oncology. Represent the program in selected external forums, including advisory boards and major oncology congresses (e.g., ASCO, ESMO, SGO).

Requirements

MD or MD/Ph.D with specialty training in gynecology and subspecialty training in gynecologic oncology is required.
5+ years of pharmaceutical or biotechnology drug development experience with a focus on oncology drug development.
Demonstrated leadership of global, cross-functional development programs.
Proven track record advancing programs through key clinical and regulatory milestones, including PoC and registrational trials.
Strong understanding of global regulatory expectations for oncology products, including expedited pathways.
Well versed in Good Clinical Practice (GCP) and committed to upholding the highest standards of research integrity.
Proven matrix leadership with influence across functions and geographies.
Strategic thinker with strong execution rigor and attention to detail.
Ability to synthesize complex scientific, clinical, and operational data into clear recommendations for senior leadership.
Excellent communication and stakeholder-management skills.

Nice To Haves

Direct experience in gynecologic malignancies strongly preferred.

Responsibilities

Accountable for designing and implementing the Clinical Development (CD) strategy and plans in gynecologic oncology from first-in-human through registration.
Lead and chair the Global Program Team (GPT), aligning Clinical Development, Translational Medicine, Regulatory Affairs, CMC, Safety, Biostatistics, Clinical Operations, Medical Affairs, and Commercial.
Define clear program objectives, milestones, and decision criteria, balancing speed, differentiation, and risk.
Ensure strategic coherence across indications, lines of therapy, combinations, and geographic regions.
Provides deep clinical expertise and scientific input into trials and portfolio decisions
Integrate ADC-specific considerations into program strategy, including: Target biology and expression heterogeneity Payload mechanism, linker stability, and bystander effects Dose optimization and therapeutic index Safety and tolerability based on emerging data
Collaborate cross functionally to ensure alignment between clinical strategy and CMC readiness, particularly for scale-up, comparability, and registrational supply.
Work closely with Clinical Development leadership to ensure efficient execution of clinical studies, including meeting milestones.
Collaborates to develop the global regulatory strategy, including FDA, EMA, and other health authority interactions (e.g., EOP meetings, scientific advice, accelerated approval pathways).
define indication sequencing, trial design, endpoints, and comparator strategies in ovarian, endometrial, and cervical cancers.
Lead biomarker-driven development strategies, including patient selection, enrichment approaches, and companion/complimentary diagnostic considerations.
Oversees and participates in preparation of key program deliverables, including TPPs, integrated development plans, regulatory briefing documents, and governance materials.
Serve as the primary program representative to internal governance committees and executive leadership.
Lead scenario planning, risk assessments, and data-driven go/no-go decisions, particularly at PoC and registrational transition points.
Ensure timely escalation of issues with clear mitigation and contingency plans.
Collaborate with program management to ensure integrated timelines, budgets, and resource planning across all functions.
Ensure alignment of clinical, translational, regulatory, and CMC critical paths, especially for registrational studies.
Mentors and coaches team members to foster a high-performing culture.
Support interactions with external partners, CROs, academic investigators, and key opinion leaders in gynecologic oncology.
Represent the program in selected external forums, including advisory boards and major oncology congresses (e.g., ASCO, ESMO, SGO).