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Principal Scientist/Associate Director, Clinical Biomarker Lead

Cullinan Oncology is seeking an experienced Biomarker and Translational Sciences leader to join the Translational Research team.

The Company

Cullinan Oncology is dedicated to creating new standards of care for patients with cancer.

We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners.

Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.

Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization.

As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.

Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer.

Principal Scientist/Associate Director, Clinical Biomarker Lead

Cullinan Oncology is seeking an experienced Biomarker and Translational Sciences leader to join the Translational Research team. A successful incumbent would help integrate basic science research, proteomics, genomics and informatics to move programs into the clinic as well as leverage clinical findings to identify biomarkers and novel discovery opportunities for Cullinan’s extensive immune oncology pipeline.

  • Work closely with the preclinical group to define translational hypotheses, including potential pharmacodynamic and predictive biomarkers for novel immune oncology targets.
  • Design and implement bioanalytical, clinical biomarkers and exploratory translational strategies; adhere to clinical and regulatory submission protocols.
  • Successfully manage CROs and establish relationships to develop bioanalytical and biomarker assays, monitor assay qualification/validation at CROs, as well as bioanalytical/biomarker testing in the clinic.
  • Collaborate with clinical operations and the central lab to develop appropriate clinical laboratory manuals and to support sample management and logistics.
  • Perform integrative analysis of flow cytometry, gene expression, IHC/MultiplexIF data, and drug response data for baseline and post-dose biomarker discovery for clinical programs.
  • Drive decisions to support PK/PD, immunogenicity, and predictive biomarker analysis in clinical studies.
  • Ensure quality and timely submission of all clinical biomarker -related documents and materials for regulatory filings, including scientific advice filings, INDs, meeting briefing books, and other requests from global regulatory authorities.

Primary Job Requirements:

  • Ph.D. in Immuno-oncology, Immunology, Cancer Biology, or related field and 5 or more years of industry (biotech/pharmaceutical) clinical biomarker experience.
  • Deep understanding of the pre-clinical, translational, and clinical stages of drug development in the immune-oncology field.
  • Extensive working knowledge of biomarker and bioanalytical assay development and cutting-edge Omics methodologies in the clinic.
  • Hands-on experience with flow cytometry data analysis in clinical trials is required.

Skills and competencies

  • Experience leading within and collaborating effectively as a member of a cross-functional team.
  • Demonstrable knowledge of appropriate quality standards including ICH/GCP, and global regulations.
  • Experience in selection and management of external CROs.
  • Excellent analytical skills, with an ability to communicate complex issues in a simple way.
  • Ability to be agile and drive data-based decisions.

Contact us for more information.

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Associate Director/Director, Analytical Development Scientist

We are seeking a collaborative professional to join our team as an Associate Director or Director, Analytical Development Scientist. This teammate will support analytical activities for early and late-stage biological products and the ideal candidate will provide expertise in the field of analytical lifecycle, formulation development, protein characterization, analytical comparability, critical quality attributes (CQA)/product specifications and Drug Substance (DS)/Drug Product (DP) testing.

Cullinan Oncology is seeking an Analytical Development Scientist to join its CMC department in Cambridge, MA. The Analytical Development Scientist will report to the Sr. Director of Analytical Sciences within CMC group. Prospective candidate will support analytical activities for early and late-stage biological products in outsourced business model. He/she will work collaboratively in cross-functional teams to support process development, characterization, tech transfer and program management of Cullinan’s protein pipeline. Ideal candidate will provide expertise in the field of analytical lifecycle (development, qualification, and validation), formulation development, protein characterization, analytical comparability, critical quality attributes (CQA)/product specifications and Drug Substance (DS)/Drug Product (DP) testing.

Responsibilities

  • Collaborate with contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs) in support of analytical activities including but not limited to protein characterization, formulation and method development, method qualification/validation, DS/DP testing, data review and trending, troubleshooting, optimization, and reporting.
  • Design and/or manage execution of IND/BLA enabling studies at external partners (e.g., characterization, analytical comparability, forced degradation, formulation development, leachable/extractable, in-use studies) critically assess findings and share results with cross-functional teams.
  • Author technical reports and CMC regulatory sections.
  • Provide technical support for investigations at CTLs and CMOs, generate hypothesis, critically review results to support deviations, and out of specification (OOS) results.
  • Identify and stay current with new analytical technologies and methods for the characterization of biologics.
  • Travel to CMO/CTO sites may be required as needed for program execution and site audits.
  • Participate as appropriate in due diligence activities for new molecule/new program assessments.
  • Support technology transfer activities, as appropriate.
  • Other duties and responsibilities as required by departmental and business needs.

Requirements

  • A minimum of ten years of industry or related professional analytical and formulation experience.
  • A MS/PhD degree in analytical chemistry, biochemistry, or a related analytical scientific discipline.
  • In-depth knowledge and expertise in protein structure and analytical characterization.
  • Experience with following analytical methods: ELISAs, cell-based potency assays, HPLC, CE-SDS, CEX, icIEF, MS, DSC, AUC, CD, DLS, MFI.
  • Experience with statistical and analytical software, such as JMP, Excel, Chemstation, and/or Empower.
  • Experience in authoring technical reports and CMC regulatory sections.
  • Prior experience with CMOs and CTLs is preferred.
  • Strong interest in innovative strategies for analysis and control of new modalities of biologics.
  • Experience with trouble-shooting assays, creative problem-solving, method transfer and method validation.
  • Familiarity with cGMP standards, ICH, CFR, USP, and general guidance documents.
  • The ability to work in a fast-paced dynamic environment with changing priorities.
  • Demonstrated forward thinking skills, with the flexibility to support multiple development programs simultaneously.
  • Skilled in managing cross functional relationships and collaboration as a team member.
  • Excellent written and verbal communication skills.
  • Strong time management and organizational skills, attention to accuracy and detail, and the ability and willingness to multi-task as needed.
  • Travel to CTLs and CMOs may be required.

Contact us for more information.

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Program Leader (Director level), Biologics

The Program Leader will be responsible for overseeing one or more assets in Cullinan’s growing biologics portfolio.

Summary:

Cullinan Oncology is seeking a Program Leader to join the Development Team at Cullinan Oncology in Cambridge, MA. The Program Leader will be responsible for overseeing one or more assets in Cullinan’s growing biologics portfolio, which includes a diverse set of modalities (monoclonal antibodies, bispecific antibodies, fusion proteins, etc), targets, and mechanisms of action, with a heavy emphasis in the immuno-oncology space. The successful candidate will possess strong leadership skills, provide the needed guidance across functional areas, and be operationally minded with significant experience in drug development. The candidate will work in collaboration with an internal team, as well as in partnership with external collaborators, service providers, and consultants to advance development of the pipeline programs on time and on budget, while providing scientific rigor and expertise.

Responsibilities:

  • Serve as cross-functional Program Leader for preclinical/clinical biologics program(s)
  • Play lead role in crafting program strategy
  • Support the cross-functional team in development of timelines, planning and execution
  • Ensure alignment with project sub-teams and functional partners
  • Lead team in identifying program risks, mitigation and contingency plans
  • Prepare and track functional team budget including resources and costs, collaborating with finance and other cross-functional departments
  • Communicate, document and archive project team activities and decisions. Act as a primary contact for project team related information
  • Collaborate with legal team to develop IP strategy
  • Facilitate program and sub-team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
  • Identify, recommend and implement opportunities for streamlining / accelerating the program; identify key go/no-go program decision points
  • Lead the team in selecting CROs; manage external partners in overseeing studies, data analysis and reporting
  • Take lead role in crafting regulatory documents (e.g. IND’s), journal manuscripts, conference abstracts, and internal and external presentations
  • Participate in due diligence for inbound/outbound portfolio programs

Requirements:

  • Ph.D. in biology, biological engineering, oncology, immunology, or related field
  • At least 5 years of experience in the biotech/pharmaceutical industry
  • Experience leading preclinical/early development programs in oncology, preferably with focus in immuno-oncology
  • Deep understanding of the drug development process for biologics
  • Experience overseeing scientific teams, including management of external CROs
  • Strong interpersonal skills, ability to develop integral relationships with key stakeholders, strong conflict resolution skills
  • Excellent analytical skills, with an ability to communicate complex issues in a simple way
  • Experience with crafting regulatory documents, including INDs, and communications with regulatory authorities
  • Ability to translate strategy into action; strong communication, negotiation, and presentation skills
  • Proven track record of good decision making and exercising sound judgement
  • Results and detail-oriented; self-motivated
  • Driven to accelerate programs, with appropriate balance of risk taking
  • Highly collaborative with internal teams and external partners
  • Excellent written and oral communication skills
  • Ability to excel in a fast-paced environment

Contact us for more information.

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VP of Research

The VP of Research will be responsible for overseeing the early discovery portfolio.

Job Description: VP of Research

Hiring Manager: Jennifer Michaelson, Chief Development Officer, Biologics

Summary:

Cullinan Oncology is seeking a VP of Research to join Cullinan Oncology in Cambridge, MA. The VP of Research will be responsible for overseeing the early discovery portfolio, which includes a diverse set of modalities, targets, and mechanisms of action, with a heavy emphasis in the immuno-oncology space. The successful candidate will have deep experience in drug discovery and development, possess strong leadership skills, and have the ability to drive portfolio strategy as well as technical oversight of programs. The candidate will work in partnership with an internal team, as well as with Cullinan’s network of external collaborators, service providers, and consultants, to advance development of the pipeline programs on time and on budget, while providing scientific rigor and expertise. The VP of Research will also play a major role in refueling the pipeline with new programs, by participating in evaluation of external assets for in-licensing as well as bringing forth creative ideas for initiating new programs internally.

Responsibilities:

  • Oversee and manage discovery stage portfolio
  • Provide outstanding leadership in the management and advancement of multiple early stage programs
  • Partner with upper level management to devise overall strategy for early portfolio
  • Fuel the pipeline, including participation in due diligence of external assets for potential in-licensing and fostering innovative new ideas for programs to enter the Cullinan portfolio
  • Foster a high performing, collaborative, multi-disciplined team environment
  • Manage small team of internal scientists as well as network of scientists in Cullinan’s CRO network, plus external consultants
  • Provide technical insights and input for programs in the early portfolio
  • Lead team in highlighting program risks, developing timelines, and identifying key go/no go for portfolio programs
  • Collaborate with legal team to develop IP strategy
  • Oversee the team in selecting CROs, overseeing studies, data analysis and reporting
  • Forecast and manage budget and resource allocation for early portfolio

Requirements:

  • Ph.D. in biology, oncology, immunology, or related field
  • At least 10 years of experience in the biotech/pharmaceutical industry
  • Experience leading preclinical programs in oncology, preferably with focus in immuno-oncology
  • Deep understanding of the drug discovery and development process
  • Experience leading scientific teams, including selection and management of external CROs
  • Ability to be agile and drive data-driven decisions
  • Capable of quickly transitioning between strategic and tactical thinking
  • Creative and innovative in bringing new programs into the pipeline
  • Deep knowledge of in vitro assays and in vivo models in oncology/immuno-oncology
  • Collaborative leadership style; strong interpersonal skills
  • Excellent analytical skills, with an ability to communicate complex issues in a simple way
  • Ability to translate strategy into action; strong communication, negotiation, and presentation skills
  • Proven track record of good decision making and exercising sound judgement
  • Results and detail-oriented
  • Driven to accelerate programs, with appropriate balance of risk taking
  • Highly collaborative with internal teams and external partners
  • Experience directly managing and leading high performing teams, coaching and mentoring others to enhance performance and/or facilitate career progression
  • Excellent written and oral communication skills
  • Ability to excel in a fast-paced environment

Contact us for more information.

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