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Working at Denovo

We provide outstanding career opportunities for innovative and motivated team players who are committed to making a difference in science and human healthcare. We offer a stimulating work environment, competitive compensation, and an excellent benefits package, including medical, dental, vision, FSA, 401(k), Life Insurance/AD&D, Short Term/Long Term disability insurance and paid time off.

We believe that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

Current Career Opportunities

We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative environment and share in our mission to transform the future of medicine. We are headquartered in San Diego, CA

Applicants meeting the specified criteria for one of our open positions should send a copy of their resume to hr@denovobiopharma.com naming the position they are applying for in the subject heading.

Director/Senior Director, Clinical Development

Position Summary
Reporting to the Head of Clinical Development, the Director/Senior Director, Clinical Development is responsible for developing and executing global clinical strategy and tactical plans for one or more asset. This person will engage and establish credibility with the medical community and, working with the Head of Clinical Development, will ensure alignment and execution of internal and external priorities and activities. The successful candidate must be a creative leader who adapts quickly to evolving circumstances and is able to succeed in a fast-paced environment.

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Director/Senior Director, Clinical Development

Company Description

Denovo Biopharma LLC, a clinical-stage biotechnology company that employs novel and proprietary biomarker discovery methodology to advance drug development.  Our primary strategy is to rescue promising therapies in oncology and CNS diseases by defining biomarkers that identify patients most likely to benefit from these treatments. Three assets are in development and a global phase 3 clinical trial is currently enrolling patients.

Position

Reporting to the Head of Clinical Development, the Director/Senior Director, Clinical Development is responsible for developing and executing global clinical strategy and tactical plans for one or more asset. This person will engage and establish credibility with the medical community and, working with the Head of Clinical Development, will ensure alignment and execution of internal and external priorities and activities.

The successful candidate must be a creative leader who adapts quickly to evolving circumstances and is able to succeed in a fast-paced environment.

Duties and Responsibilities

  • Serve as the medical and clinical lead for one or more asset
  • Serve as the medical monitor for one or more clinical trial
  • Provide medical and clinical development expertise
  • Participate in defining and implementing clinical strategy for one or more asset
  • Establish relationships with key opinion leaders and ensure that significant developments in the field are identified and monitored; serve as the clinical lead for advisory meetings
  • Responsible for preparing clinical portions of regulatory documents including INDs, NDAs, investigator brochures, drug safety update reports, and clinical study reports
  • Accountable for clinical protocol development and preparation
  • Responsible for pharmacovigilance activities for clinical studies, including the review and reporting of SAEs (with support from the pharmacovigilance team)
  • Participate in the oversight and management of vendors/CROs
  • Prepare manuscripts and abstracts and make presentations at scientific meetings
  • Provide Medical/Clinical support to other functional areas
  • Participate in business development processes as needed, including due-diligence, and partnering activities
  • Perform other duties as required

Qualifications and Experience

  • MD required
  • At least 4 years drug development experience within the biotechnology or pharmaceutical industry, preferably in oncology
  • Demonstrated understanding of FDA requirements, good clinical practices, and pharmaceutical clinical development in oncology
  • Demonstrated ability to contribute meaningfully to deliver clinical development strategy
  • Possesses at least a basic understanding of biostatistics and pharmacokinetics
  • Ability to work collaboratively in a dynamic team-based, matrixed environment
  • Experience leading and managing clinical development programs
  • Ability to travel domestically and internationally

Senior Data Manager/Manager, Data Management

Position Summary
The Senior Data Manager/Manager, Data Management will lead and coordinate data management activities for multiple assigned projects within Denovo. This position has oversight of activities leading to the final delivery of clean, QC’d clinical data for the purpose of clinical study reports and publications, including submission to regulatory agencies. This position provides technical and operational expertise to the Denovo project teams under the guidance of the Senior Director, Data Management and will work together to define end to end processes and procedures for the set-up, collection, and management of clinical data.

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Senior Data Manager/Manager, Data Management

Position Summary

The Senior Data Manager/Manager, Data Management will lead and coordinate data management activities for multiple assigned projects within Denovo. This position has oversight of activities leading to the final delivery of clean, QC’d clinical data for the purpose of clinical study reports and publications, including submission to regulatory agencies. This position provides technical and operational expertise to the Denovo project teams under the guidance of the Senior Director, Data Management and will work together to define end to end processes and procedures for the set-up, collection, and management of clinical data.

Essential Functions And Responsibilities

These may include, but are not limited to:

  • Lead data management activities for Denovo studies, to include database setup, CRF design and validation, edit checks, ongoing data review, SAE reconciliation, Medical Coding, Protocol Deviations and critical data review towards final database lock
  • Review and approve data management plans (DMP) and review statistical analysis plans (SAPs) and shells for tables, listings, figures
  • Manage and oversee contract research organizations (CROs) handling clinical trial data
  • Take a lead role in the review, issue and resolution of Sponsor queries for CRF cross-functional data cleaning (based on edit checks, manual review and from the Denovo Biopharma Data Review Plan)
  • Work with study team members by preparing and distributing study related reports, resolving questions, and providing DM guidance
  • Work with data management, biostatistician, and SAS programmers to harmonize data collection, compile and maintain SAS data standards, including CDASH CRF collection, CRF specification guidelines and edit check documents
  • Support the review of the critical data-populated tables, figures, and listings as part of the database clean-up and prior to database lock
  • Provide technical assistance supporting (and creating new) standards within the DM department, driving standards to be utilized across all Denovo Biopharma sponsored studies
  • Support Denovo Biopharma’s business development efforts as needed
  • Maintain all the necessary documentation to support accuracy and integrity of clinical databases
  • Co-author and maintain appropriate data management SOPs
  • Review statements of work, work orders and bids from vendor contracts
  • Assure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines

Job Qualifications

Education, Certifications, Experience

  • Bachelor’s degree in life sciences with a minimum of 5+ years (8+ years for Manager, Data Management) experience working in a CRO, pharmaceutical or biotech environment (an equivalent combination of education and experience may be considered)
  • Degree in math, computer science or related field is a plus

Knowledge, Skills and Abilities

  • Working knowledge of data management software (EDC, IXRS, ePRO, and other remote capture systems used in the industry), database design and programming is a plus
  • Excellent verbal and written communication skills
  • Effective time, cost and resource management skills
  • Knowledge of SAS, Understanding of CDISC standards (CDASH, SDTM, etc) is highly desired
  • Equipment:  PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained.  Knowledge of other equipment required: N/A
  • Software Knowledge:  MS Office (Outlook, Word, Excel, Power Point), Microsoft Project, SAS.  Knowledge of other software required: EDC

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Notice to Recruiters

Denovo Biopharma’s Human Resources Department manages the recruitment and employment process for the Company and all candidates must be presented through this Department. If your agency wishes to establish a relationship with Denovo Biopharma, you must work directly with the Human Resources Department. Contacting our hiring managers or employees directly is not appropriate. For more details, please email hr@denovobiopharma.com. Denovo Biopharma will only accept resumes from recruiters if an executed agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Denovo Biopharma from recruiters do not constitute any type of relationship between the recruiter and Denovo Biopharma and do not obligate the Company to pay fees should we hire from those resumes.

About Us

Denovo Biopharma is a privately held biotech company providing a novel biomarker solution to personalize drug development. Our platform can be broadly applied to biomarker discovery in many therapeutic areas, such as oncology, metabolic, cardiology, immunology and neurology.

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