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PRIMARY RESPONSIBILITY

Responsibilities include a variety of activities involved in implementation of clinical trials.  Develop protocols, case report forms, informed consent forms, and other study documents; interact with data management personnel to plan data entry, instream data cleaning, and analysis; monitor sites for appropriate sample collection, work closely with translational medicine and biostats to perform analysis of pharmacokinetic and pharmacodynamic studies, organize investigators' meetings; assure timely completion of studies; monitor data for safety and efficacy trends by reviewing clinical data; and write clinical reports (in cooperation with other functions e.g., medical and statistical staff).  Prepare clinical portions of INDs, CTAs, protocols, investigator brochures, annual updates etc. Participate in the selection of investigators/clinical trial sites, contract research organizations (CROs) and outside vendors. Directs planning, implement activities and provide CRO/vendor oversight required to conduct and monitor clinical trials and ensure that Good Clinical Practices (GCP) are followed. Evaluate/monitor site pre-study, at study initiation, at regular intervals during the study and at study closeout. Assess investigator performance and adherence to protocol, and proactively address conduct issues and enrolment problems, as necessary.  Develop a study plan, timetable, budget and resource analysis (together with other members of the team and functions). Maintain relationships with alliance partners, external companies, investigators and opinion leaders to optimize performance on clinical trial activities.

Key Responsibilities

Describe the essential duties

1

Contribute to relevant study documents including clinical protocols/amendments, informed consent forms, eCRF design, clinical study reports, operational plans etc.  Co-ordinate the preparation and publication of reports, ensuring that they meet regulatory, contractual and ethical requirements.

2

Manage study operational plan and CRO activities, including study timeline and recruitment plan to ensure high quality deliverables

3

Participate in the selection of vendors for clinical trials.  Maintain frequent and meaningful contact with CROs to assess performance and provide oversight and guidance as needed.

4

Participate in the selection of investigational sites with input from relevant stakeholders

5

Monitor trial progress to ensure compliance with and adherence to the project plan and proactively identify, evaluate and rectify problems. Oversee clinical trial sites’ adherence to pertinent regulations through review of monitoring reports, audit reports, communication with investigators, study site personnel, CRAs, and CRO personnel

6

Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes. Proactively identify risks and provides solutions to clinical trial issues

7

Lead clinical data monitoring, data review, protocol deviation review and other review activities and ensure GCP

8

Oversight of creation and maintenance of all trial files, including the trial master file, and oversight of site files.

9

Provide or facilitate training of clinical study team members and clinical trial site personnel on assigned protocol specific topics

10

Work closely with other functions in the organization (e.g., regulatory, quality)

11

Management of the trial budget(s)

12

Assurance that personal and confidential information is restricted to those entitled to know

 

Qualifications & Experience

Describe required and desirable educational requirements, experience and qualifications.

Required

PhD in Life/Health Science, PharmD, MS or BS in a scientific or health care field (e.g., nursing, pharmacy, physician's assistant) and 8+ years of clinical research experience in pharmaceutical or biotechnology organization(s). Ability to author relevant subsections of key clinical documents, including but not limited to protocol, IBs, DSURs, CSR, clinical safety narratives, ICFs, INDs, CTAs, etc.  Experience negotiating vendor/site contracts and managing budgets. Providing CRO management and oversight.  Thorough understanding of FDA, ICH and GCP guidelines. Experience in early phase oncology clinical development is essential. 

Desirable

Immuno-oncology drug development experience

NDA experience

Phase I/II/III clinical trials experience

 

Skills & Competencies

Describe required and desirable skills and competencies needed to successfully perform the role.

Required

Thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.

Collaborate with internal/external stakeholders to achieve efficient execution of clinical studies

Excellent communication skills, collaborative style of working, strong attention to detail, meticulous, report writing skills (including protocols, DSURs, IBs, etc), the ability to work professionally and productively under pressure. Previous mentorship experience of junior colleagues and medical monitors with limited clinical development experience. Demonstrated experience leading the successful development of complex drug therapies on time, on budget, and with quality assurance and regulatory compliance. Experience in eCFR design, translational medicine, clinical pharmacology, and biostatistics.

Desirable

Experience managing external alliances