Senior Manager, Global Data Generation

Summit Therapeutics; Palo Alto (CA); Sur place; USD 158 000 - 185 000; Plein temps

Résumé du poste

Summit Therapeutics is seeking a Senior Manager, Global Data Generation to lead operational execution of Investigator Sponsored Trials and real-world studies within Medical Affairs. You will manage protocol reviews, budgets, drug shipments, and cross-functional collaboration with RMSDs, PIs, and external partners to ensure timely progress.

The ideal candidate has 3+ years in clinical trial management, strong regulatory knowledge, and excellent communication.

Qualifications

• Bachelor’s or master’s degree in life sciences; an advanced degree is preferred.
• 3+ years in clinical trial management in CRO/pharma/biotech.
• Strong understanding of regulatory requirements in clinical development.

Responsabilités

• Manage all operational aspects of studies, including protocol/consent review and drug shipments.
• Manage concept proposal intake, submission portal, and communication with investigators.
• Prepare materials/minutes for Scientific Review Committee meetings.
• Oversee study budgets, Fair Market Value analysis, and budget negotiations.
• Coordinate with RMSDs/MSLs, principal investigators, and external partners to track proposals and timelines.
• Support analyses, tracking, and reporting of study progress and metrics.
• Track milestones and work with Finance for budget reconciliation and forecasting.
• Collaborate with study site/drug supply to forecast drug supply for the program.
• Participate in cross-functional meetings to provide program updates and address issues.
• Ensure compliance with SOPs and continuously improve processes.

Connaissances

Communication

Cross-functional collaboration

Regulatory knowledge

MS Office

Multi-tasking

IST platforms

Budgeting

Project coordination

Formation

Bachelor's or master's degree in life sciences

Advanced degree preferred (PhD/PharmD)

Outils

iEnvision ISR platform

IQVIA Grant Plan for Investigators

Description du poste

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.

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:

Summit Therapeutics is seeking a Senior Manager, Global Data Generation (Sr. Mgr.), to join our mission of developing Ivonescimab, a novel and unique immunotherapy with the potential to help patients suffering from life-threatening cancers. This position will focus on supporting the Global Non-Sponsored Research Program led by Medical Affairs, including Investigator Sponsored Trials (ISTs), Cooperative Group studies, as well as real-world evidence studies. The Sr. Mgr. contributes to key aspects of the program and is responsible for activities associated with the activation, tracking, and reporting of study-related information. This role provides an opportunity to work in a cross-functional environment, interfaces frequently with Summit’s Scientific Review Committee, field medical affairs, external collaboration partners and investigators, including key opinion leaders.

The ideal candidate will thrive in a fast-paced environment and be adept at collaborating with external stakeholders and cross-functional internal teams.

Role and Responsibilities:

• Manage all operational aspects of studies, including protocol/consent review, document management, fair market value evaluations, contract execution, drug shipments, and maintain ongoing oversight of project to ensure timelines and team goals are met
• Manage the concept proposal intake process, maintain the submission portal and review status, document decisions and communicate with investigators and research coordinators
• Assist with agenda and prepare meeting materials/minutes for Scientific Review Committee meetings
• Responsible for obtaining internal approval of associated study budget, perform Fair Market Value analysis, conduct budget negotiations when needed
• Work closely with Regional Medical Science Directors (RMSDs)/Medical Science Liaisons (MSLs), principal investigators, and other external parties to maintain central progress tracker for all approved proposals to ensure study timelines are met
• Support ongoing analyses, tracking and reporting of study progress versus timelines committed by investigators, data delivery and program impact, and other related metrics
• Track achievement of milestones that trigger payment, and work with Finance to perform budget reconciliation as well as forecast future milestones
• Work with study site/drug supply team to manage and forecast drug supply for the program
• Participate in cross-functional team meetings to provide updates on the program and address any issues or concerns
• Collaborate cross-functionally with internal stakeholders, including medical affairs, clinical development, regulatory, drug supply, etc.
• Adheres to all relevant processes, training, and SOPs to ensure consistency, efficiency, and compliance.
• Continued process improvements to ensure consistency, efficiency, and compliance.

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s or master’s degree in life sciences with relevant experience; an advanced degree (e.g., PharmD, PhD) is preferred
• 3+ years of relevant experience working in clinical trial management in CRO, pharmaceuticals/biotech, or related roles within the pharmaceutical or healthcare industry
• In-depth understanding of the healthcare and pharmaceutical landscape and phases of clinical drug development and processes, including regulatory requirements
• Familiarity with software platforms for managing ISTs (e.g. iEnvision ISR platform) and tools and fair market value analysis (e.g. IQVIA Grant Plan for Investigators)
• Scientific and medical terminology acumen, experience in Oncology strongly preferred
• Strong organizational skills, attention to detail, critical thinking and high problem-solving abilities
• Excellent communication and interpersonal abilities
• Ability to work collaboratively across diverse teams and manage multiple stakeholders
• Proficient user of the standard MS Office suite (e.g., Word, Excel, PowerPoint); experience with electronic document management systems and document review tools is desirable
• Self-motivated, ability to multi-task and work independently and achieve success with little oversight or guidance

This is the pay for this position

Pay Transparency

$158,000 - $185,000 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Summit Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

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