Director, Clinical Sciences
Director, Clinical Sciences
Summit Therapeutics, Inc.
United States
See who Summit Therapeutics, Inc. has hired for this role
Our Mission
To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.
We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational cooperative binding bispecific antibody targeting PD-1 and VEGF combining the effects of immunotherapy and anti-angiogenesis. Recent data suggests that ivonescimab will be the best-in-class checkpoint inhibitor. We have initiated two registration enabling phase 3 clinical trials in lung cancer and are planning multiple additional Phase 3 clinical trials across multiple tumor types.
Overview Of Role
The Director, Clinical Science 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 Science will strive to drive study enrollment, and build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues. The Director, Clinical Science will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved.
Role And Responsibilities
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 human resources department to obtain prior written authorization before referring any candidates to Summit.
To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.
We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational cooperative binding bispecific antibody targeting PD-1 and VEGF combining the effects of immunotherapy and anti-angiogenesis. Recent data suggests that ivonescimab will be the best-in-class checkpoint inhibitor. We have initiated two registration enabling phase 3 clinical trials in lung cancer and are planning multiple additional Phase 3 clinical trials across multiple tumor types.
Overview Of Role
The Director, Clinical Science 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 Science will strive to drive study enrollment, and build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues. The Director, Clinical Science 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 (eg, 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
- MS (or equivalent) required,
- PhD, PharmD, or MD preferred
- 8+ 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
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 human resources department to obtain prior written authorization before referring any candidates to Summit.
-
Seniority level
Director -
Employment type
Full-time -
Job function
Strategy/Planning and Information Technology -
Industries
Biotechnology Research
Referrals increase your chances of interviewing at Summit Therapeutics, Inc. by 2x
See who you knowGet notified about new Clinical Director jobs in United States.
Sign in to create job alertSimilar jobs
People also viewed
-
Associate Director, Clinical Science
Associate Director, Clinical Science
-
Head of Epidemiology and Preparedness
Head of Epidemiology and Preparedness
-
HEALTH & SCIENCE COMMUNICATIONS DIRECTOR (Government) - D.C. Area ONLY (contractor part time)
HEALTH & SCIENCE COMMUNICATIONS DIRECTOR (Government) - D.C. Area ONLY (contractor part time)
-
Director of Engineering
Director of Engineering
-
Director and Lead for Gen Med Bone Health MSL Team
Director and Lead for Gen Med Bone Health MSL Team
-
Director, Science Products & Programs, People eXperience and Technology Central Science
Director, Science Products & Programs, People eXperience and Technology Central Science
-
Director, Conservation Social Science
Director, Conservation Social Science
-
Director, Machine Learning
Director, Machine Learning
-
Sr Director, Data Science Engineering (AI/ML Products)
Sr Director, Data Science Engineering (AI/ML Products)
-
Sr Director, Data Science Engineering (AI/ML Products)
Sr Director, Data Science Engineering (AI/ML Products)
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub