CAREERS

MANA Therapeutics is a clinical stage cell therapy company with pioneering solutions for cancer, bringing powerful cell therapies to bear on cancers with an unmet medical need. Focusing on novel ways of educating our endogenous immune cells, we have devised clinical cell immune therapies that can eliminate cancer cells and are both safer and have greater breadth than existing therapies.  MANA’s initial focus is acute myeloid leukemia post stem cell transplants.

Senior Scientist, Immunology

The successful candidate will be part of the Immunology research team, which is developing T-cell therapies targeting multiple tumor-associated-antigens that are preferentially overexpressed on wide range of solid cancers and hematological malignancies. The candidate will participate in design, execution, and reporting of experiments aimed at elucidating the functionality and potency of our current T-cell approach; and will participate in the development of a new T-cell approaches to enhance product attributes and support path forward toward clinical development. Importantly, the candidate is expected to take on scientific leadership of preclinical activities.

Position Responsibilities include:

 

  • Design and execution of scientific studies; including the detailed experimental protocols incorporating relevant and sensitive analytical methodologies; at Mana’s laboratories, at collaborator laboratories, and/or at CRO sites. 

  • Maintains detailed records; and analyzes and interprets results from all scientific studies and writes technical reports to support publications / presentations, quality requirements, regulatory submissions, any intellectual property filings.

  • Contributes to Mana’s laboratory procedures; equipment and reagent upkeep and maintenance; and participates in routine laboratory operational and safety related duties.

  • Serves as a subject matter expert on T-cell biology and function; and maintains current awareness of developments and analytical methodologies in the scientific fields.

  • Represents Mana in the scientific community; and leads data presentations and scientific discussions at scientific meetings and conferences.

 

Candidate Requirements:

  • PhD in Immunology or a relevant field with at least 5 years experience, and relevant work experience with strong knowledge of the adaptive and innate immune system, as well as oncology

  • Significant experiences in in vitro immunological assessment of cellular function and potency is required, with additional experiences in in vivo animal models being preferred.

  • Prior experience cell isolation, cell culture, multi-parametric flow cytometry, various immunological functional assays is must.

  • Detail oriented and objective data analytical abilities with excellent communication skills.

  • Ability to work independently, as well as in a collaborative environment to meet project goals with attention to detail, and with excellent written and oral communication skills

  • Enjoys solving challenging scientific questions in a fast pace environment

Head of Research, Immunology

The Head of Research, Immunology will develop and lead the execution of the Company’s strategy and activities for the preclinical development of Mana’s lead asset and pipeline products.  This includes overseeing the design, performance, and analysis of results of in vitro studies, in vivo translational studies, and clinical immunology research studies, to characterize critical product attributes, toxicity, and efficacy of Mana’s EDIFY™ platform products.   S/he will be responsible for building out Mana’s R&D laboratory infrastructure and research team; managing outsourced research organizations, and will work in matrix structure within a relatively lean organization.

Position Responsibilities include:

 

  • Leads Mana’s research function to generate comprehensive scientific data to encompassing characterization of Mana products and in vitro and in vivo assessment of safety and biological activity.

  • S/he will be responsible for design and execution of all research studies at Mana’s laboratories, at collaborator laboratories, and/or at CRO sites.  

  • S/he will be responsible for analysis of results from all scientific studies (including if needed the writing of) and for review and approval of all study reports for purposes of scientific, regulatory, and/or intellectual property submissions.

  • Translates scientific learnings into process and product characterization associated with Technical Operations and Quality teams to guide the continual refinement of the robustness, scalability, and comparability of current and future manufacturing processes.

  • Owns the roadmap and execution responsibility for longer-term research studies aimed at enhancing potency of EDIFY™ Platform Products.

  • Builds internal structure, leads and motivates creation of research organization to deliver on research milestones and IP strategies including, selecting and managing relationships with collaborators and contract research organizations.

  • Direct the implementation of research processes including implementation of laboratory IT systems to support research documentation (data, protocols, reports, patent applications)

  • Collaborates with CTO to establish and execute on strategy for external collaboration and grant and supports build out an external R&D Engine to identify additional synergies and applications for Mana’s EDIFY™ Platform

  • Represents Mana in scientific community, builds strong relationships with KOLs, and represents Mana at scientific symposia and discussions with potential strategic partners.

  • As required, performs scientific diligence to evaluate new product opportunities or alliances;  participates in business development activities providing scientific input into discussions and plays a key role in alliance management, working with pharma partners to set the strategic direction and oversees the delivery of joint projects

  • Contribute to the Leadership Team’s and the Board’s understanding of Immunology to facilitate objective data-driven decision making and resource prioritization

  • Maintains awareness of developments and competitor activity in fields relevant to Mana

 

Candidate Requirements:

 

  • PhD (or preferably, MD/PhD) in Immunology or a relevant field with at least 10 years of biotechnology company experience, with at least 5 years in a functional leadership role

  • Strong understanding of antigen presenting cell and antigen-specific T-cell biology, preferably with experiences related to the development of allogenic products

  • Prior experience identifying, vetting, and contracting with external vendors for execution of internally directed programs, and experience with the subsequent management and oversight of these collaborators is required.

  • Prior experience with leading or contributing to pre-clinical or clinical sections of regulatory filings with translational development of T-cell immunotherapies is strongly preferred.

  • Detail oriented and objective data analytical abilities with excellent communication skills.

  • Ability to work independently as an individual contributor initially; with demonstrated ability to grow and mentor the R&D organization.

  • Highly collaborative individual that thrives in a fast-paced start up environment.  

Director/Sr. Director of Clinical Operations

Position Responsibilities include:

 

  • Oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical programs.

  • Develop and implement clinical project plans in accordance with corporate and regulatory objectives

  • Contribute to key study documents in conjunction with other functional area leads (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)

  • Manage clinical trial resources and reforecasting projections, including hiring plans and external budgets

  • Maintain an inspection readiness state throughout the lifecycle of the trial

  • Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget

  • Contribute to global clinical / regulatory submissions

  • Communicate study updates to senior leadership and in open forum presentations

  • Lead development of departmental SOP’s and ensure compliance

  • May require travel

 

Candidate Requirements:

 

  • Bachelor’s in a scientific discipline; advanced degree preferred

  • Minimum 7 years of experience in a biotech/pharmaceutical, principally in oncology drug development and  clinical operations

  • Comfortable in a fast-paced small biotech environment with the ability to adapt to change

  • Experience over-seeing CRO partners as the point of contact and lead project manager

  • Cell therapy experience a bonus

  • Highly organized, outcome oriented, self-motivated performance

  • Hands-on working style with ability to play as individual contributor as needed

  • In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget

  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, strong conflict management and negotiation skills

  • Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice

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