Tarsus Pharmaceuticals, Inc.
Sr Director, Clinical Development
Tarsus Pharmaceuticals, Inc., California, Missouri, United States, 65018
Overview
The Sr. Director, Clinical Development is a hands-on leader in the Clinical Development function who makes strategic contributions across the portfolio and the business. They provide leadership and oversight while developing and ensuring effective and efficient execution of the clinical development plan (CDP). The role also includes Program Team Lead (PTL) activities, managing one or more programs by leading multidisciplinary/cross-functional teams from relevant expert functions, as part of the company’s strategy. Responsibilities
Provide strategic leadership and oversight for the design, execution, and delivery of clinical development programs in support of the CDP, including document development (INDs, Protocols, IBs, regulatory documents), medical and scientific input for study activation and conduct (CRFs, SAP, data listings), data review processes, and other deliverables as needed. Shape and drive the development of strategic clinical initiatives, including disease area strategy, target product profile (TPP), and clinical development plans. Apply deep therapeutic area and clinical development expertise to influence enterprise-level program decisions. Oversee and interpret clinical data at the portfolio level; ensure insights inform regulatory strategy, publications, and corporate goals. Stay abreast of internal and external developments to maintain a current view of influences and implications for the assigned therapeutic/disease areas. Demonstrate hands-on leadership across all aspects of clinical development, engaging cross-functional teams to ensure strategic alignment, operational excellence, and timely execution of program deliverables. Lead clinical development efforts in infectious disease, leveraging prevention-focused strategies to design innovative trials, inform regulatory interactions, and accelerate program advancement in high unmet need populations. Ensure effective and efficient execution of the CDP from protocol development to study close-out for assigned molecule(s)/indication, including risk/benefit assessments, scenario planning, and program-level decision making. Attend and contribute to meetings with Health Authorities related to clinical programs; develop responses to Health Authorities and IRBs on clinical questions. Represent the company with cooperative groups/alliance partners, key opinion leaders, and other stakeholders to provide and gather scientific/clinical consultation. For critical programs, serve as Program Team Leader with responsibilities including cross-functional alignment, strategy integration, timelines, budgets, and value creation for the Target Product Profile; communicate updates, risks, and opportunities to executive leadership; anticipate and mitigate program risks; identify strategic opportunities; and detail Go/No Go criteria and scenario planning. Build organizational capability and foster a culture of scientific rigor, operational excellence, and innovation. Qualifications
Advanced clinical/science degree preferred (MD, PharmD, PhD, or equivalent). 15+ years pharma/biotech industry experience. At least 10 years of hands-on experience in clinical trial design, execution, and oversight across Phase I-III programs. Extensive knowledge of clinical research methodologies and global regulatory requirements (GCP, ICH, FDA, EMEA, NICE). Demonstrated success leading multifunctional teams and managing external partners, including CROs. Therapeutic experience in Ophthalmology and/or infectious disease (including Lyme disease) beneficial. Experience working across research, clinical, non-clinical development and commercial functions to align strategy and execution. Excellent communication and collaboration skills, with a proven ability to influence stakeholders and foster a culture of teamwork. Role Details & Benefits
The position will be based in Irvine, CA (hybrid work environment; remote work option available). The role reports directly to the SVP, Development. Some travel may be required – up to 30%. Compensation: the expected base pay range for this position is $247,500 - $346,500 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position; individual pay will be determined by factors such as skills, experience, and education. Benefits include health, dental, and vision insurance; generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap. Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Note: This refined description excludes extraneous postings and focuses on the role-specific responsibilities, qualifications, and key details relevant to the Sr. Director, Clinical Development position.
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The Sr. Director, Clinical Development is a hands-on leader in the Clinical Development function who makes strategic contributions across the portfolio and the business. They provide leadership and oversight while developing and ensuring effective and efficient execution of the clinical development plan (CDP). The role also includes Program Team Lead (PTL) activities, managing one or more programs by leading multidisciplinary/cross-functional teams from relevant expert functions, as part of the company’s strategy. Responsibilities
Provide strategic leadership and oversight for the design, execution, and delivery of clinical development programs in support of the CDP, including document development (INDs, Protocols, IBs, regulatory documents), medical and scientific input for study activation and conduct (CRFs, SAP, data listings), data review processes, and other deliverables as needed. Shape and drive the development of strategic clinical initiatives, including disease area strategy, target product profile (TPP), and clinical development plans. Apply deep therapeutic area and clinical development expertise to influence enterprise-level program decisions. Oversee and interpret clinical data at the portfolio level; ensure insights inform regulatory strategy, publications, and corporate goals. Stay abreast of internal and external developments to maintain a current view of influences and implications for the assigned therapeutic/disease areas. Demonstrate hands-on leadership across all aspects of clinical development, engaging cross-functional teams to ensure strategic alignment, operational excellence, and timely execution of program deliverables. Lead clinical development efforts in infectious disease, leveraging prevention-focused strategies to design innovative trials, inform regulatory interactions, and accelerate program advancement in high unmet need populations. Ensure effective and efficient execution of the CDP from protocol development to study close-out for assigned molecule(s)/indication, including risk/benefit assessments, scenario planning, and program-level decision making. Attend and contribute to meetings with Health Authorities related to clinical programs; develop responses to Health Authorities and IRBs on clinical questions. Represent the company with cooperative groups/alliance partners, key opinion leaders, and other stakeholders to provide and gather scientific/clinical consultation. For critical programs, serve as Program Team Leader with responsibilities including cross-functional alignment, strategy integration, timelines, budgets, and value creation for the Target Product Profile; communicate updates, risks, and opportunities to executive leadership; anticipate and mitigate program risks; identify strategic opportunities; and detail Go/No Go criteria and scenario planning. Build organizational capability and foster a culture of scientific rigor, operational excellence, and innovation. Qualifications
Advanced clinical/science degree preferred (MD, PharmD, PhD, or equivalent). 15+ years pharma/biotech industry experience. At least 10 years of hands-on experience in clinical trial design, execution, and oversight across Phase I-III programs. Extensive knowledge of clinical research methodologies and global regulatory requirements (GCP, ICH, FDA, EMEA, NICE). Demonstrated success leading multifunctional teams and managing external partners, including CROs. Therapeutic experience in Ophthalmology and/or infectious disease (including Lyme disease) beneficial. Experience working across research, clinical, non-clinical development and commercial functions to align strategy and execution. Excellent communication and collaboration skills, with a proven ability to influence stakeholders and foster a culture of teamwork. Role Details & Benefits
The position will be based in Irvine, CA (hybrid work environment; remote work option available). The role reports directly to the SVP, Development. Some travel may be required – up to 30%. Compensation: the expected base pay range for this position is $247,500 - $346,500 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position; individual pay will be determined by factors such as skills, experience, and education. Benefits include health, dental, and vision insurance; generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap. Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Note: This refined description excludes extraneous postings and focuses on the role-specific responsibilities, qualifications, and key details relevant to the Sr. Director, Clinical Development position.
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