Sr/Executive Director, Clinical Science

POSITION SUMMARY:

The Senior/Executive Director, Clinical Scientist will be a critical member of a multi-disciplinary team supporting the overall clinical development of evorpacept. In this role, they are responsible for leading/contributing to study design and execution of clinical studies in oncology. As a leader within the clinical organization, this individual will be partnering with clinical operations, biostats, regulatory and other cross-functional team members to develop and refine clinical plans, author key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data. This team member will strive to drive study enrollment and build collaborative relationships with investigators and clinical site staff, CROs, and ALX colleagues. They will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved.

PRIMARY RESPONSIBILITIES AND DUTIES:

• Clinical Trial Oversight: Oversee and collaborate with the study clinician and cross-functional partners for study startup, review and provide content for ICFs, protocol amendments, and regulatory documents; assist with data cleaning to support outputs for regulatory documents, external data presentations, and database lock activities; author and review CRFs; provide CRO oversight, in conjunction with clinical operations, for assigned clinical studies and function as point of contact for clinical inquiries from CRO medical monitor/sites; support site protocol training; ensure trial conduct in accordance with GCP and applicable regulatory requirements.
• Clinical Strategy: provide input on major clinical trial milestones and timelines; assist with authoring of clinical sections for regulatory documents (e.g., Investigators’ Brochures, IND/BLA submissions, responses to Health Authority queries); provide strategic direction for data listings, SAP, and DM plan; assist with clinical indication and protocol planning; participate in Health Authority meetings as requested; partner with clinical lead to maintain study alignment with company objectives; participate in drafting of scientific publications.
• Data Analysis: collaborate with clinical operations, data management and cross-functional partners to develop and implement the overall data quality plan and lead internal medical data review and safety trend analysis on one or more studies/programs ; collaborate with research, preclinical development and translational scientists to support and analyze biomarker study data.
• External Collaboration: partner with the clinical lead to develop working relationships with study investigators and key opinion leaders; develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.); support SIV’s, and site visits.
• Scientific Publications: Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders; coordinates submissions to scientific meetings and/or other appropriate venues or groups
• May perform management responsibilities as needed.
• Other duties as assigned.
  
  
  

QUALIFICATIONS AND SKILLS:

• Doctorate degree, PharmD, or equivalent with postgraduate training in oncology or related specialty with eight (8) years of relevant experience in clinical trial conduct, clinical data collection, analysis, and interpretation.
• Ten plus (10+) years’ experience in the biotech/pharmaceutical industry.
• Experience with FDA regulations and expectations, GCP, ICH guidelines, and clinical drug development.
• Proven track record of scientific publications.
• Strong verbal and written communication skills and collaborative attitude.
• Highly motivated and able to work both independently and collaboratively in a fast-paced environment with a desire to learn and tackle new challenges.
• Comfortable with Windows, Outlook, Power Point, Word, Excel, and with accessing and working with electronic data capture systems.
• Expertise in interpreting immunology/immune-oncology clinical data
• Domestic and/or international travel may be required up to 20% of work time.
• Remote/Hybrid work model acceptable (US West Coast/Bay Area preferred)
  
  
  

SALARY RANGE: $240,000 - $290,000 DOE

PHYSICAL DEMANDS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.

• Must be able to interact and communicate in written and oral forms with a diverse group of individuals on both technical and business topics.
• The ability to sit, stand, kneel, stoop, walk, use hands to finger, handle, or feel, point, and reach with hands and arms.
• Must be able to travel up to 20% of the time without restriction, domestically and/or internationally.
• Must be able to use the telephone and communicate clearly with a host of external individuals, domestically and globally.
• Ability to work at a computer for extensive periods of time.
• Ability to work in a fast-paced working environment managing multiple tasks.
  
  
  

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

ALX Oncology is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

About Alx Oncology

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. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action.

For more information about us, please visit http://www.alxoncology.com