Associate Director, Clinical Data Management

• Bachelor’s degree in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience
• A minimum of 10+ years of Clinical Data Management experience (oncology experience highly desirable) in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
• Experience with various data collection and Electronic Data Capture (EDC) systems and understanding of the MedDRA and WHODRUG coding processes
• Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants
• Excellent interpersonal, communication, and leadership skills
• Consistent, detail oriented, communicative, dedicated to do a job well done
• CRO and vendor oversight experience preferred
• Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

This is the pay for this position

• 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.

• 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.

We are looking for an experienced Associate Director, Clinical Data Management that will contribute to and support the company's research and development efforts to create high value therapeutics to address unmet medical needs. The Associate Director, Clinical Data Management independently leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. This role will direct the planning, implementation and overall direction of executing/achieving clinical trial data management activities including CRF/eCRF design, database development, validation programming, data review, discrepancy management, and database lock.

Additionally, the position will manage data management staff, Contract Research Organizations (CROs) and service providers' activities in overseeing the data management process life cycle in coordination with internal Biostatistics, Clinical, and Regulatory teams to ensure the accurate, efficient, and complete data collection for clinical trials.

$174,000—$205,000 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 recruiting@smmttx.com to obtain prior written authorization before referring any candidates to 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: