Vice President, Clinical Development

Trimaren Human Capital Partners; Watertown (MA); On-site; USD 250,000 - 420,000; Full time

Job summary

Confidential Biotech in Massachusetts, in stealth mode, is seeking a Vice President, Clinical Development to lead strategies for rare disease, hematology, and hematologic oncology programs. You will translate scientific insights into executable development plans and guide programs through clinical milestones that inform patient benefit and portfolio decisions.

This role offers hands-on leadership, opportunities to influence development strategy while staying close to data and science, and to

Qualifications

• MD/DO/PhD or equivalent advanced degree in a relevant clinical or scientific discipline.
• 15+ years of relevant experience in drug development, including substantial direct clinical development experience within biotechnology or pharmaceutical companies and increasing responsibility for program strategy and delivery.
• Direct clinical development experience in rare disease, hematology, or hematologic oncology, with a strong understanding of the relevant disease biology, treatment landscape, and unmet patient needs.
• Demonstrated ownership of clinical development plans and studies, with a record of advancing programs through meaningful development milestones and explaining the decisions that shaped their progress.
• Strong knowledge of clinical trial methodology, including protocol design, endpoint selection, dose selection, safety evaluation, and interpretation of clinical and translational data.
• Experience translating mechanistic and biomarker findings into clinical hypotheses, patient-selection strategies, and development decisions.
• Experience contributing to regulatory submissions and agency interactions, with an understanding of how clinical evidence supports the development and potential registration of new therapies.
• Demonstrated ability to lead cross-functional teams, resolve competing priorities, and make sound recommendations when data are incomplete or development paths uncertain.
• Practical knowledge of GCP and clinical study oversight, including the operational challenges of enrollment, site engagement, and trial execution in specialized patient populations.
• Strong communication skills, with the ability to clearly explain complex findings and development trade-offs to investigators, cross-functional partners, and executive stakeholders.
• A collaborative, accountable leadership style, with the willingness to contribute directly to critical work and help colleagues succeed in a fast-moving environment.

Responsibilities

• Define development objectives, indication priorities, and key milestones, aligning clinical plans with disease biology, unmet patient need, regulatory considerations, and portfolio objectives.
• Guide the development of study concepts, protocols, eligibility criteria, endpoints, and dose-selection strategies that can establish safety, characterize pharmacologic activity, and evaluate clinical benefit.
• Partner with Translational Science and Biometrics to integrate biomarkers, patient-selection approaches, and clinically meaningful endpoints into studies appropriate for rare diseases and small patient populations.
• Establish criteria for dose escalation, proof of concept, and program advancement. Interpret emerging safety, efficacy, and translational data; assess uncertainty; and recommend when to advance, adapt, or discontinue a development approach.
• Align Clinical Operations, Regulatory Affairs, Safety, Biometrics, Translational Science, and CMC around integrated development plans, realistic timelines, critical dependencies, and resource needs.
• Partner with Clinical Operations on investigator and site strategy, enrollment feasibility, CRO and vendor oversight, protocol implementation, and resolution of issues affecting study quality or delivery.
• Ensure emerging findings receive timely review and that benefit-risk considerations inform study conduct and development decisions.
• Partner with Regulatory Affairs on briefing materials, submissions, responses to agency questions, and discussions that shape the clinical development path.
• Engage investigators, clinical advisors, and patient organizations to inform development strategy, study feasibility, and understanding of outcomes that matter to patients. Represent the Company in advisory boards and scientific forums.
• Mentor colleagues, guide internal and external contributors, and establish practical approaches that support scientific rigor, patient safety, ethical conduct, data integrity, and inspection readiness.
• Present clear assessments of clinical opportunity, program risk, development options, and resource tradeoffs to senior leadership.

Skills

Leadership

GCP knowledge

Trial design

Regulatory submissions

Biomarker strategy

Rare disease expertise

Stakeholder communication

Program strategy

Education

MD/DO/PhD

Job description

Confidential Biotech | Stealth Mode | On-Site in MA

As Vice President, Clinical Development, you will shape and lead the clinical development strategy for the Company's programs in rare disease, hematology, and hematologic oncology. You will translate scientific and translational insights into rigorous, executable development plans and guide programs through clinical milestones that inform patient benefit, program advancement, and portfolio decisions.

The Company pairs scientific rigor with a clear sense of urgency for patients. This role offers the opportunity to influence development strategy while staying close to the science, the data, and the work required to advance clinical programs. You will bring sound judgment, hands-on leadership, and the ability to align cross-functional teams around clear priorities and decisions.

Key Responsibilities

• Define development objectives, indication priorities, and key milestones, aligning clinical plans with disease biology, unmet patient need, regulatory considerations, and portfolio objectives.
• Guide the development of study concepts, protocols, eligibility criteria, endpoints, and dose-selection strategies that can establish safety, characterize pharmacologic activity, and evaluate clinical benefit.
• Partner with Translational Science and Biometrics to integrate biomarkers, patient-selection approaches, and clinically meaningful endpoints into studies appropriate for rare diseases and small patient populations.
• Establish criteria for dose escalation, proof of concept, and program advancement. Interpret emerging safety, efficacy, and translational data; assess uncertainty; and recommend when to advance, adapt, or discontinue a development approach.
• Align Clinical Operations, Regulatory Affairs, Safety, Biometrics, Translational Science, and CMC around integrated development plans, realistic timelines, critical dependencies, and resource needs.
• Partner with Clinical Operations on investigator and site strategy, enrollment feasibility, CRO and vendor oversight, protocol implementation, and resolution of issues affecting study quality or delivery.
• Ensure emerging findings receive timely review and that benefit-risk considerations inform study conduct and development decisions.
• Partner with Regulatory Affairs on briefing materials, submissions, responses to agency questions, and discussions that shape the clinical development path.
• Engage investigators, clinical advisors, and patient organizations to inform development strategy, study feasibility, and understanding of outcomes that matter to patients. Represent the Company in advisory boards and scientific forums.
• Mentor colleagues, guide internal and external contributors, and establish practical approaches that support scientific rigor, patient safety, ethical conduct, data integrity, and inspection readiness.
• Present clear assessments of clinical opportunity, program risk, development options, and resource tradeoffs to senior leadership.

Requirements

• MD, DO, PhD, or equivalent advanced degree in a relevant clinical or scientific discipline.
• 15+ years of relevant experience in drug development, including substantial direct clinical development experience within biotechnology or pharmaceutical companies and increasing responsibility for program strategy and delivery.
• Direct clinical development experience in rare disease, hematology, or hematologic oncology, with a strong understanding of the relevant disease biology, treatment landscape, and unmet patient needs.
• Demonstrated ownership of clinical development plans and studies, with a record of advancing programs through meaningful development milestones and explaining the decisions that shaped their progress.
• Strong knowledge of clinical trial methodology, including protocol design, endpoint selection, dose selection, safety evaluation, and interpretation of clinical and translational data.
• Experience translating mechanistic and biomarker findings into clinical hypotheses, patient-selection strategies, and development decisions.
• Experience contributing to regulatory submissions and agency interactions, with an understanding of how clinical evidence supports the development and potential registration of new therapies.
• Demonstrated ability to lead cross-functional teams, resolve competing priorities, and make sound recommendations when data are incomplete or development paths uncertain.
• Practical knowledge of GCP and clinical study oversight, including the operational challenges of enrollment, site engagement, and trial execution in specialized patient populations.
• Strong communication skills, with the ability to clearly explain complex findings and development trade-offs to investigators, cross-functional partners, and executive stakeholders.
• A collaborative, accountable leadership style, with the willingness to contribute directly to critical work and help colleagues succeed in a fast-moving environment.

Additional Experience We Value

• Designing or leading first-in-human, dose-finding, or clinical proof-of-concept studies.
• Developing precision medicines or biomarker-informed clinical strategies.
• Conducting trials in rare hematologic diseases or other small, heterogeneous patient populations.
• Building clinical development capabilities or mentoring clinical scientists and development teams.
• Working in an emerging biotechnology company with evolving priorities.