Upstream Bio
Senior Director, Clinical Operations Indication Lead
Upstream Bio, Waltham, Massachusetts, United States, 02254
Senior Director, Clinical Operations Indication Lead
Senior Director, Clinical Operations Indication Lead
The Senior Director, Clinical Operations Indication Lead oversees the planning and execution of clinical trials within assigned indication(s) and in a fully outsourced model. Reporting to the SVP, Clinical Operations & Medical Writing, this role leads indication-level clinical operations strategy planning, ensures study delivery within indication in line with overarching timelines and goals, and contributes to clinical development strategies. The individual in this role will also serve as the clinical trial lead on our most complex clinical trials, responsible for end-to-end operational execution including timelines, budget, vendor oversight and quality deliverables. The ideal individual has a strong scientific background with deep experience leading programs from first-in-human through later-stage development. This individual must integrate scientific, clinical, and business factors into cohesive operational strategies, while maintaining a deep understanding of disease indications, patient needs, regulatory guidance, and the competitive landscape. Exceptional cross-functional collaboration, communication skills, adaptability, and a solutions-oriented mindset are essential for success in this fast-paced, patient-focused environment. Key Responsibilities: Lead the Clinical Operations Indication team (direct reports and/or contractors, focusing on clinical operations leadership, clinical trial/vendor management, patient recruitment & retention, with dotted line responsibilities for clinical monitoring oversight, and vendor oversight and governance) to deliver high-quality clinical trials within indication. Develop and implement strategic plans for indication-level clinical development operations that align with company goals, product profile and regulatory expectations. Lead operational input into lifecycle planning activities (such as pediatric investigational plan) for the indication. Oversee vendor selection, timelines, budget, contract negotiations, resource allocation and performance management within indication. Serve as the clinical trial lead on our most complex clinical trials, responsible for end-to-end operational execution including timelines, budgets, vendor oversight, and quality deliverables. Act as a subject matter expert and provide indication-specific operational guidance to colleagues across the clinical program. Support the development of colleagues through informal mentoring and best practice sharing. Ensure compliance with ICH GCPs, ICH guidelines, FDA/EMA regulations, and internal policies and procedures for all studies within indication, to maintain ongoing inspection readiness. Collaborate closely with cross-functional partners to align operational plans with overall program strategy, proactively manage risks, and ensure timely, high-quality execution within indication. Establish risk-oriented oversight and management for all relevant CROs and vendors including contracting and clinical budgets; develop contingency plans for clinical trials. Ensure effective risk identification & mitigation strategies as well as proactively identify & resolve issues within indication. Establish an open team culture defined by transparent communication, clear goal setting, and risk-based oversight.Partner closely with the Senior Vice-President, Head of Clinical Operations, to shape department-wide processes, organizational strategy, and long-term capability building tailored to the needs of a small biotech. Qualifications: Bachelor’s degree or international equivalent required; Life sciences preferred. Advanced degree highly desirable. 12+ years of clinical operations leadership roles leading global clinical studies/programs. Skills, Knowledge & Abilities: In-depth knowledge of GCP ICH guidelines and FDA/EMA regulations. Experience with clinical trial audits and inspections. Global clinical operations & development experience across therapeutic areas with demonstrated ability to rapidly learn new indications. Experience with and ability to develop/contribute to and execute clinical development plans, integrating scientific, regulatory, and business perspectives into trial strategy, aligning indication goals with corporate portfolio objectives. Experience with regulatory submissions (IND, NDA, BLA,…) Excellent critical and strategic thinking. Strong ability to understand the big picture as well as the important details that may impact the big picture. Excellent communicator and influencer, able to persuasively convey both ideas and data, verbally and in writing. About Upstream Bio Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and have initiated the development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Research Referrals increase your chances of interviewing at Upstream Bio by 2x Sign in to set job alerts for “Director Clinical Operations” roles.
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Senior Director, Clinical Operations Indication Lead
The Senior Director, Clinical Operations Indication Lead oversees the planning and execution of clinical trials within assigned indication(s) and in a fully outsourced model. Reporting to the SVP, Clinical Operations & Medical Writing, this role leads indication-level clinical operations strategy planning, ensures study delivery within indication in line with overarching timelines and goals, and contributes to clinical development strategies. The individual in this role will also serve as the clinical trial lead on our most complex clinical trials, responsible for end-to-end operational execution including timelines, budget, vendor oversight and quality deliverables. The ideal individual has a strong scientific background with deep experience leading programs from first-in-human through later-stage development. This individual must integrate scientific, clinical, and business factors into cohesive operational strategies, while maintaining a deep understanding of disease indications, patient needs, regulatory guidance, and the competitive landscape. Exceptional cross-functional collaboration, communication skills, adaptability, and a solutions-oriented mindset are essential for success in this fast-paced, patient-focused environment. Key Responsibilities: Lead the Clinical Operations Indication team (direct reports and/or contractors, focusing on clinical operations leadership, clinical trial/vendor management, patient recruitment & retention, with dotted line responsibilities for clinical monitoring oversight, and vendor oversight and governance) to deliver high-quality clinical trials within indication. Develop and implement strategic plans for indication-level clinical development operations that align with company goals, product profile and regulatory expectations. Lead operational input into lifecycle planning activities (such as pediatric investigational plan) for the indication. Oversee vendor selection, timelines, budget, contract negotiations, resource allocation and performance management within indication. Serve as the clinical trial lead on our most complex clinical trials, responsible for end-to-end operational execution including timelines, budgets, vendor oversight, and quality deliverables. Act as a subject matter expert and provide indication-specific operational guidance to colleagues across the clinical program. Support the development of colleagues through informal mentoring and best practice sharing. Ensure compliance with ICH GCPs, ICH guidelines, FDA/EMA regulations, and internal policies and procedures for all studies within indication, to maintain ongoing inspection readiness. Collaborate closely with cross-functional partners to align operational plans with overall program strategy, proactively manage risks, and ensure timely, high-quality execution within indication. Establish risk-oriented oversight and management for all relevant CROs and vendors including contracting and clinical budgets; develop contingency plans for clinical trials. Ensure effective risk identification & mitigation strategies as well as proactively identify & resolve issues within indication. Establish an open team culture defined by transparent communication, clear goal setting, and risk-based oversight.Partner closely with the Senior Vice-President, Head of Clinical Operations, to shape department-wide processes, organizational strategy, and long-term capability building tailored to the needs of a small biotech. Qualifications: Bachelor’s degree or international equivalent required; Life sciences preferred. Advanced degree highly desirable. 12+ years of clinical operations leadership roles leading global clinical studies/programs. Skills, Knowledge & Abilities: In-depth knowledge of GCP ICH guidelines and FDA/EMA regulations. Experience with clinical trial audits and inspections. Global clinical operations & development experience across therapeutic areas with demonstrated ability to rapidly learn new indications. Experience with and ability to develop/contribute to and execute clinical development plans, integrating scientific, regulatory, and business perspectives into trial strategy, aligning indication goals with corporate portfolio objectives. Experience with regulatory submissions (IND, NDA, BLA,…) Excellent critical and strategic thinking. Strong ability to understand the big picture as well as the important details that may impact the big picture. Excellent communicator and influencer, able to persuasively convey both ideas and data, verbally and in writing. About Upstream Bio Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and have initiated the development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Research Referrals increase your chances of interviewing at Upstream Bio by 2x Sign in to set job alerts for “Director Clinical Operations” roles.
Executive Director/Vice President, Clinical Operations
Waltham, MA $186,000.00-$255,000.00 4 days ago Senior Director/Executive Director Clinical Operations
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Wellesley, MA $129,200.00-$193,800.00 6 days ago Chestnut Hill, MA $248,320.00-$310,400.00 1 week ago Vice President , Business Operations and Clinical Analytics
Beverly, MA $71,668.00-$89,585.00 1 month ago Cambridge, MA $202,940.00-$250,690.00 1 week ago Senior Director, Clinical Operations/Development
Waltham, MA $194,000.00-$267,000.00 1 day ago Area Vice President, Clinical Operations / RN - Home Care
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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