- Develop clinical trial strategies for Oncology products in clinical development.
- Design, plan, analyze, report, and publish ALX Oncology sponsored clinical trials.
- Work with cross functional teams to support execution of each assigned study.
- Develop collaborative relationships with Research, CMC, and Business Development, stakeholders.
- Work with multidisciplinary team to support data cleaning and database lock activities.
- Work with multidisciplinary teams to ensure quality oversight of the study (quality, regulatory, and safety).
- Lead the development of clinical sections for regulatory submissions.
- Ensure that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trial(s).
- Develop working relationships with key investigators in the oncology area to maximize scientific quality in clinical study design, execution, reporting, and publication.
- Contribute to the development of clinical sections of regulatory documents (i.e., Investigators' Brochures, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
- Oversee trial-related advisory boards, investigator meetings.
- Work with CRO data management and clinical sub-team on data integrity and analysis for study and planned/actual filing activities as required.
- Serve as the external clinical "face" of the program in interactions with investigators, development partners, and advisory boards as needed.
- Collaborate with research and preclinical development scientists to support regulatory submissions (i.e., Breakthrough/FastTrack Designation, pre-IND an IND submission for new drug candidates).
- Hire and supervise employees, both directly and indirectly.
- Oversee performance management and career development for direct reports.
- MD or MD PhD with board certification, or eligibility in Oncology or Hematology/Oncology or related specialty required.
- Minimum 10 years clinical research experience in Oncology Clinical Development within a biotechnology and/or pharmaceutical company.
- Demonstrated leadership overseeing development programs with multiple assets across solid and hematologic indications.
- Expertise in the design, execution, and reporting of late-stage clinical trials in Oncology with small and/or large molecule drug candidates.
- Broad understanding of Oncology, Internal Medicine, and Clinical Pharmacology.
- Excellent working knowledge of FDA and EMA regulations and expectations, GCPs, ICH guidelines, and clinical drug development.
- Strong communication and collaboration skills.
- Comfortable with Windows, Outlook, PowerPoint, Word, Excel, and with accessing and working with IVRS and electronic data capture systems.
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Senior/Executive Medical Director, Clinical Development - South San Francisco, United States - ALX Oncology Holdings Inc.
Description
ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway.Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain.
For more information about us, please visitReporting to the Senior Vice President of Clinical Development, the Senior/Executive Medical Director, Clinical Development will play a critical role in developing and executing the ongoing clinical trial strategies for our Oncology products.
Major Duties/Responsibilities:
Qualifications:
Salary:
$240,000-$300,00 DOE
ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.
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