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Senior Director- Clinical Biomarker Strategy Lead

Cambridge, MassachusettsFull-time
About the Job
Senior Director, Clinical Biomarker Strategy Lead (Oncology)

The Role:
We are seeking a highly motivated and experienced individual with deep translational expertise to join the Oncology Translational Medicine team within Clinical Development at HiFiBiO. The Clinical Biomarker Strategy Lead will work closely with the VP of Clinical Pharmacogenomics and the Clinical Operations team to achieve the company’s scientific and strategic objectives focused on maximizing clinical outcomes. The Lead will bring deep scientific experience in immuno-oncology biomarkers, in-depth knowledge of oncology, and understanding of clinical development. The Lead will be responsible to design, deliver and execute biomarker and translational strategies, including clinical pharmacodynamics, proof of mechanism, target engagement, and patient selection strategies, in alignment with clinical development objectives for the HiFiBiO programs. The successful candidate will have the opportunity to build a team to support the clinical biomarker programs across the pipeline. 

Responsibilities: 
  • Lead clinical asset biomarker strategy within early clinical development programs to generate data that inform clinical mechanism of action and patient selection.
  • Provide input to the clinical team on biomarker-related elements of clinical protocols, IBs, INDs, CTAs, CSR, and publications.
  • Provide scientific expertise and technical guidance to enable timely and high-quality sample collection
  • Collaborate with clinical operations, the CRO, and testing labs to ensure biomarker testing and data generation
  • Lead data generation efforts and clinical biomarker sample analysis, data interpretation, and communication to the clinical team 
  • Ensure output of biomarker plans meets clinical program quality standards
  • Align with the translational bioinformatics team and our Drug Intelligent Science to deliver novel approaches to select patients for treatment
  • Provide guidance and scientific input for the execution of biomarker plans for the early development programs
  • Proactively seek novel ways to incorporate single-cell technologies and biomarkers into clinical designs
  • Contribute to building a culture that embraces scientific excellence and integrity with a sense of collaboration internally and externally
 
Qualifications:
  • MD, Ph.D. or MD/Ph.D. degree with 8+ years of experience of relevant industry experience, preferably within translational biomarker roles 
  • Deep understanding of the role of translational research and clinical biomarkers in drug development
  • Demonstrated scientific acumen and mechanistic understanding of cancer biology and experience in oncology and immuno-oncology clinical development
  • Experience with bioanalytical assays, including multi-parameter flow cytometry, multiplex IF assays, single-cell RNA sequencing 
  • Flexibility to support multiple projects as the pipeline evolves
  • Ability to work in a fast-paced environment and driving towards results
  • Excellent written and verbal communication skills 
  • Preferred working knowledge of data analysis and experience with reporting tools
  • Strong interpersonal skills and ability to work collaboratively across teams
  • Companion diagnostic development, including experience of IDE submission and approval, is a plus

To Apply:
Please send a cover letter briefly stating why your skills set would suit the job and your reasons for applying as well as your CV.  All CVs will be reviewed at our earliest availability.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
Our Human Resources team manages the recruitment and employment process for HiFiBiO Therapeutics. To protect the interests of all parties involved, HiFiBiO will only accept resumes from a recruiter if an executed search agreement directed to the particular position(s) is in place. Unsolicited resumes sent to HiFiBiO from recruiters do not constitute any type of relationship between the recruiter and HiFiBiO and do not obligate HiFiBiO in any way to pay any fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees; no response will be provided to such contact or presentation.

We are an Equal Opportunity Employer. Applicants and employees are considered for positions and evaluated without regard to mental or physical disability, race, color, religion, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, gender expression, transgender status, marital status or any other protected Federal/National, State/Province, or Local status unrelated to the performance of the work involved.
About HiFiBiO Therapeutics

HiFiBiO Therapeutics is an emerging multinational company mobilizing the human immune system to combat disease and transform patient care. We integrate deep-rooted biological expertise, apply advanced single-cell profiling technologies and leverage open-innovation strategies to accelerate the development of a repertoire of innovative antibody drugs to treat cancer and autoimmune disorders. HiFiBiO fosters a fast-paced and engaging work environment, providing high growth opportunities to our employees to learn new skills and tackle new challenges on a daily basis.