Director, Clinical Scientist

OpenKrill; United States; Remote; USD 192,000 - 239,000; Full time

Job summary

Summit Therapeutics Inc. is seeking a Director, Clinical Scientist to lead study design and execution in hematology/oncology.

You will partner with clinical operations, translational science, and other teams to craft clinical plans, author/regulatory documents, and drive data interpretation and delivery. The role focuses on Amgen/Harmoni-like programs including bladder cancer Harmoni-GU1 in development, with close collaboration with investigators, CROs and internal Summit colleagues.

Qualifications

• MS (or equivalent) required; PhD, PharmD, or MD preferred.
• Minimum of 5+ years overall related experience with PhD or like degree; Minimum of 2+ years’ experience in oncology/hematology clinical studies.
• Excellent written and verbal communication skills.
• Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data.

Responsibilities

• Leads/contributes to study design and amendments in collaboration with internal and external scientific stakeholders.
• Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation.
• Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs.
• Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders.
• Develops input for clinical presentation slides and materials for meetings and communications (investigator meetings, site visits, training, newsletters, etc.).
• Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan).
• Participates in safety meetings and tracks, analyzes, and reviews documentation for safety events.

Skills

Excellent written and verbal comms

Immunology/immuno-oncology data interp

Education

MS or equivalent

PhD/MD/PharmD preferred

Job description

About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

• -HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• -HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• -HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• -HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:

The Director, Clinical Scientist is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. As a leader within the clinical organization, this individual will be partnering with clinical operations, translational, and other matrix team members to design and refine clinical plans, authoring key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data. The Director, Clinical Scientist will strive to drive study enrollment and build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues. Bladder Cancer Harmoni-GU1: Randomized Phase 2/3 Study of Ivonescimab in Combination with Enfortumab Vedotin vs Pembrolizumab in Combination with Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma. The Director, Clinical Scientist will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved.

Role and Responsibilities:

• Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders
• Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
• Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs
• Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders
• Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
• Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan, etc.)
• Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events
• Leads/Contributes to the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
• Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
• Coordinates submissions to scientific meetings and/or other appropriate venues or groups
• Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• MS (or equivalent) required; PhD, PharmD, or MD preferred
• Minimum of 5+ years overall related experience with PhD or like degree; Minimum of 2+ years’ experience in conducting / supporting oncology/hematology clinical studies
• Excellent written and verbal communication skills
• Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data

This is the pay for this position

Pay Transparency$192,000-$239,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [e-mail] to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.