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Medical Director

Houston, TX 77051

Posted: 09/27/2022 Employment Type: Direct Hire/Perm Job Number: 506296-1 Country: United States Is job remote?: Yes

Job Description


 

The Medical Director  will be part of the Clinical Development and Operations Groups which are responsible for driving clinical development strategy and execution.

This role will have direct responsibility for the design, execution, oversight and analyses of clinical trials of Oncology TAC-T Cell Therapy. The Medical Director will also work closely with the technical and R&D/Translational Medicine teams to incorporate the appropriate biomarker studies into the protocol and to correlate clinical and translational findings to drive optimal clinical development. In addition, this individual will be providing medical and scientific expertise to cross-functional colleagues and play a critical role partnering with the Chief Medical Officer (CMO) in defining the clinical strategy for the company.

Job Duties
  • Medical Monitoring
  • Medical review of trial data, including reviewing eligibility data
  • Clinical site interactions including addressing medical questions and providing site education (including safety management) and assessment of key safety-related serious adverse events and approving safety narratives
  • Drafting of clinical protocols, along with medical writing & colleagues from Clinical Operations and providing the medical strategic oversight of protocol development including study design, targeted patient populations, eligibility criteria and defining safety risks & mitigation strategies
  • Fulfilling GCP and compliance obligations for clinical conduct and maintaining all required training
  • Contributing to the Clinical Strategy and Clinical Development Plans for the company’s asset(s)
  • Providing oversight and medical accountability for the company’s clinical trials
  • Identifying/ building relationships with principal investigators and KOLs on the treatment modality, indication and novel clinical trial designs and biomedical statistical analyses
  • Supporting the executional delivery of clinical studies (e.g., site activation, status of enrollment, adjudication for protocol violations, medical validation/ data clean-up and as the medical resource for the site staff)
  • Interacting with Health Authorities & IRBs/ECs as the Clinical Program Lead
  • Drafting and authoring clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filing of the study in partnership with colleagues in clinical operations.
  • Staying current on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to strategy or clinical development plan if needed
  • Maintaining a clinical and scientific reputation in the modalities and diseases pertinent to the company

 

Education & Certifications

MD is required (or a US-equivalent)

Sub-specialty training in Medical Oncology and/or Hematology

 

Work-related Skills & Experience
  • 5 or more years of Biotech/Pharma industry experience in Oncology Clinical Trial development and execution 
  • Experience in the drug development process, delivering and executing on effective clinical trial plans and protocols
  • Leadership and mentorship skills with a hands-on (working leader) approach is required
  • Proven ability to lead teams, especially in a remote/virtual environment and cross functionally is very important
  • Ability to travel up to 30% (domestic and international)

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com, @theplanetforward.com, @planet-technology.com, @planet-pro.com, @planetinteractive.com, @pfes.com, @launchcg.com, @planet-pharma.com, @planet-healthcare.com) - and not a domain with an alternative extension like .net, .org or .jobs.

The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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