Sr. Director, Clinical Pharmacology & DMPK
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Job Location:
Palo Alto, CA - USA
Yearly Salary:
$ 230000 - 275000
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
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. Summits 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.
Summits team is inspired to touch and help change lives through Summits 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 Chinas 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:
Manage clinical pharmacology pharmacokinetic (PK) drug metabolism (DM) and bioanalytical (BA) supports for Summits assets. Responsible for PK and PKPD data analysis to support projects.
Role and Responsibilities:
- Serve as Clinical Pharmacology and DMPK subject matter expert on cross-functional teams in both early and late-stage projects
- Define ADME strategy to achieve target product profile
- Design and outsource in vitro and in vivo ADME studies to characterize the compounds
- Oversee external bioanalysis including validation and sample analysis
- Design and perform complex PK analysis model development population PK and PK/PD analyses
- Interprets and presents Clinical Pharmacology and DMPK scientific data/results to the team
- Assists in clinical study protocol design sample collection plan data analysis/interpretation and reporting
- Write review and edit relevant sections of regulatory submissions IND DSUR NDA etc. and respond to queries from regulatory agencies
- All other duties as assigned
Experience Education and Specialized Knowledge and Skills:
- Ph.D. Pharm.D. or equivalent training in Pharmacokinetics Pharmaceutical sciences Biostatistics or related disciplines with a minimum of 7 years of clinical pharmacology industry experience or M.S. with 10 years of relevant experience
- Hands-on experience with standard PK Software (e.g. Phoenix WinNonlin)
- Demonstrated computational skills related to pharmaceutical or biomedical research with hands-on programming skills in SAS R MATLAB; experiences with population PK analysis and PKPD modeling tools (e.g. NONMEM and other modeling platforms) are required.
- Detail-oriented highly organized and able to manage multiple tasks
- Strong project management skills detail-oriented highly organized ability to prioritize and manage multiple projects simultaneously
- Ability to function in a fast-paced environment with good communication and problem-solving skills
The pay range for this role is $230000-$275000 annually. 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 Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Exec
Key Skills
- Fundraising
- Management Experience
- Coaching
- Analysis Skills
- Strategic Planning
- Team Management
- Budgeting
- Leadership Experience
- Mentoring
- Public Speaking
- negotiation
- Supervising Experience
About Company
Summit is committed to leadership in resolving serious, unmet medical needs in oncology for the betterment of overall HUMAN HEALTH. Stifel Fireside Chat Patients & Caregivers Summit Latest News Committed to Optimizing Human Health Summit Therapeutics Inc. is a biopharmaceutical oncolo ... View more
