Senior Director, Clinical & Transplant

Job Title: Job Title: Associate Scientist, TCR Discovery of Shared Antigens
FLSA Status: Full-Time/Exempt
Department: Clinical Development
Date: April 22, 2022
Manager: CMO
Location: Pittsburgh, PA
Job Code: BIO-22-032

BlueSphere Bio was founded to deploy its novel TCXpress technology to unlock the potential of personalized T cell therapy for the treatment of cancer by harnessing the unique specificity of each patient’s T cells for the molecular fingerprint of each patient’s cancer.

Our trailblazing, proprietary TCXpress platform is an elegant, rapid approach that exploits the patient’s immune defenses to attack their cancer specifically and is designed to leave normal tissues untouched, thereby reducing harmful side effects.

The TCXpress platform and its implementation will deliver rapid, personalized T cell treatments for various cancer indications.

Purpose

The Senior Director, Clinical & Transplant, will actively participate in all aspects of Clinical Research, working collaboratively with the Clinical Study Team and contributing to the strategic planning and execution of Clinical Plans. The Senior Director, Clinical & Transplant, reports to the Chief Medical Officer and is located in Pittsburgh, PA or remote.

Duties and Responsibilities

  • Collaborates with Project Management, Clinical Operations, and all departments in the preparation of clinical development plans, protocols, investigator brochures, IND annual reports, clinical study reports, abstracts, and manuscripts
  • Participate in vendor bid defense meetings and vendor selection
  • Develops and delivers clinical training for relevant BSB, vendor, and site staff Review safety data to ensure the safety of study participants in clinical studies
  • Presents at Investigator meetings, Trial update/reinvigoration meetings, and at Regulatory interactions
  • Identify Program risks, and creates and implement mitigation strategies with Clinical Operations and Quality Assurance
  • Answer inclusion and exclusion questions from investigative sites, CRAs, and the study teams
  • Responsible for review and analysis of clinical data including safety monitoring and medical encoding and SAE reconciliation
  • Ensure that clinical trial data are accurate, complete, and verifiable and that the conduct of the trial complies with the currently approved protocol/amendments and follows all applicable SOPs and regulatory expectations and ICH/GCP
  • Plays a key role in Pharmacovigilance of all activities and submissions
  • Ability to organize and lead clinical development advisory boards and safety monitoring boards
  • Other duties as assigned

Qualifications and Work Experience

  • M.D. degree preferred – US Board Certified Oncologist or hematologist-oncologist required with a fellowship in BMT
  • Five (5) years of total clinical research experience in the industry is preferred
  • Familiar and comfortable with clinical concepts, practices, and regulations regarding clinical research trials experience with regulatory interactions leading to drug approval strongly preferred
  • Ability to build constructive, trusting, and respectful relationships with colleagues at all levels within and outside the organization, particularly with site Principal Investigators and their staff
  • Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills, and execute position responsibilities with minimal guidance

Physical and Mental Requirements

  • You will be expected to occasionally (1% to 20% of the time):
    • Climb stairs, ramps, ladders. Etc.
    • Stoop/crouch by bending your legs or bending down/forward at the waist
    • Reach by extending the hands/arms
    • Stand on your feet
    • Lift objects from one level to another (30 lbs. or less)
    • Carry objects (30 lbs. or less)
  • You will be expected to frequently (21% to 50% of the time):
    • Walk around the facility on foot
    • Travel approximately 25% to HQ meetings with investigators, conferences, and regulators
  • You will be expected to constantly (at least 51% of the time):
    • Sit in a normal seated position

BlueSphere Bio is an Equal Opportunity Employer (EOE) and offers employment opportunities to all qualified persons regardless of race, color, religion, sex, age, national origin or ancestry, physical or mental disability (except where physical or mental abilities are a bona fide occupational requirement), veteran status, marital status, familial status, sexual orientation, HIV-positive status, possession of the sickle cell trait, genetic characteristics, political views, and any other basis protected by federal, state or local laws.