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Company Confidential – Boston, MA
Full-Time - Permanent
Position Summary:
Our client is advancing breakthrough drug discoveries to treat neurological disorders. The lead program is a portfolio of first and best-in-class oral small-molecule drugs to treat epilepsies, chronic pain, and other neurological disorders. The Head of Regulatory Affairs will provide strategic regulatory guidance and manage global regulatory activities in collaboration with the project teams. This high-impact position requires a blend of technical expertise, leadership acumen, and interpersonal skills. This role demands a visionary leader with a passion for innovation and a commitment to maintaining the highest standards of ethical, regulatory, and scientific integrity.
Responsibilities:
• Act as an in-house regulatory expert, advising and supporting Program teams.
• Lead the implementation of global regulatory strategies, taking into consideration the overall development program objectives.
• Lead the preparatory activities for interactions with regulatory authorities and lead or co-lead face-to-face meetings.
• Manage and monitor the preparation, submission, and review of regulatory documentation in collaboration with program leaders.
• Provide regulatory support to global clinical teams on clinical development plans and clinical trial requirements.
• Participate in the review of clinical study protocols and critical non-clinical studies to ensure alignment with global regulatory requirements.
Qualifications and Experience:
• MD, Master’s degree, or Ph.D. in a relevant field.
• Minimum 15 years of regulatory experience in pharmaceutical development in both large and small start-up pharma and biotech environments.
• A track record of successful management and authoring of regulatory filings and communication with various Regulatory Authorities.
• Proven track record in influencing and shaping optimal regulatory outcomes.
• Proven ability to work effectively in a team environment and matrix structure is critical.
• Experience building and leading teams in a startup environment.
Company Confidential - Greater Boston Area
Full-Time - Permanent
Position Summary:
•Our clinical-stage biotech client seeks a Chief Medical Officer (CMO) to join its leadership team. Our client is poised to disrupt the market with the development of best and first-in-class treatment for oncology targets with unmet needs. Our client has thoughtfully built an impressive leadership team that offers a positive and collaborative culture.
Responsibilities:
• Lead all aspects of the organization’s clinical drug development initiatives.
• Provide internal medical expertise and hands-on support during clinical study design, study participant safety, and protocol development.
• Participate in Board and SAB meetings, including the organization of a clinical advisory board.
• Management of external consultants, CROs, or other service providers.
• Successfully represent the company’s clinical programs, strategic vision, and data to key opinion leaders, investors, corporate partners, Board of Directors, and other key stakeholders.
• Manage the presentation of scientific data to regulatory authorities and appropriate scientific groups.
• Act as the primary public medical face at major industry conferences, maintaining awareness of cutting-edge developments and promoting the company's interests.
Qualifications and Experience:
• Board-certified MD or MD/PhD in Oncology (preferred) and respected as a patient-focused clinician with relevant industry experience in a rapidly growing biotech setting.
• 15+ years of experience in the biopharma industry, including oncology company experience.
• Demonstrated expertise in drug development strategy and implementation, pipeline
assessment, and asset allocation of oncology targets.
• Past success establishing and fostering key partnerships and collaborations with the external scientific and medical communities (academia, regulatory bodies, and other stakeholders) and a robust personal network of outside experts, consultants, and service providers.
• Personal characteristics include building authentic relationships, strategic thinking, leadership in managing organizational growth, integrity, and accountability.
Company Confidential – Boston, MA
Full Time – Permanent
The Opportunity
A well-funded small molecule biotech with locations in Boston and New York seeks a Senior Director of Biology to drive pipeline programs across several disease areas from early target discovery to IND. The Senior Director of Biology will oversee ongoing programs, contribute to new programs, and collaborate across all of R&D to build a robust pipeline of internal and partnered programs.
Key Responsibilities
● Lead a biology team in leveraging the company’s therapeutic platform
● Oversee the design, implementation, and analysis of preclinical data including cellular functional assays and in vivo studies
● Refine therapeutic workstreams and candidate evaluation strategies across integrated teams from early-stage discovery to candidate selection
● Provide key insights into early target prioritization and disease/indication expansion
● Establish a roadmap for building capabilities to achieve balanced infrastructure leveraging both internal expertise and external resources
● Promote strong scientific excellence and foster an open culture of ideation, innovation, and deep scientific rigor
● Deliver and present key data packages and data-driven scientific updates to the organization that impact pipeline milestones and corporate objectives
The Person
● Ph.D. with a minimum of 10 years of discovery research experience in the pharma/biotechnology industry and 8 years of specific leadership and/or management experience
● Experience leading small molecule drug discovery through hit, lead, and candidate selection
● Excellent oral, written, and strategic thinking skills with demonstrated ability to successfully lead the ideation and development of a plan and move to action
● Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment
● Willingness to provide leadership and role modeling for members of the team and other parts of the organization
Location
This position is based in Boston, MA. Candidates must be willing to relocate or commute to the Boston area.
Company Confidential - Waltham, MA
Full-Time
Position Summary:
•Our commercial-stage biotech client seeks a Chief Medical Officer (CMO) to join its leadership team. Our client continues to expand its support for children and adults living with rare diseases. Our client has thoughtfully built an impressive leadership team that offers a positive and inclusive culture.
Responsibilities:
•Provide internal medical expertise and support during clinical study design, study participant safety, and protocol development.
•Act as the medical representative at major industry conferences, regulatory meetings, and commercial partners.
Qualifications and Experience:
• Board-certified MD or MD/PhD (preferred) with relevant industry experience in a commercial biotech setting.
•10+ years of experience in the biopharma industry, including rare-disease company experience.
•Therapeutic area knowledge in nutrition, gastroenterology, gastrointestinal oncology, or neonatology preferred.
•Experience with developing clinical trial designs for early and late-stage programs.
•Past success in establishing key partnerships and collaborations with the external scientific and medical communities (academia, regulatory bodies, and other stakeholders).
•Understands how to create and maintain high-performing teams that achieve corporate milestones, and support a culture of accountability and transparency.
•Adaptability and experience maximizing limited resources to achieve successful outcomes.
•Proven track record of success, especially in establishing relationships with KOLs and in team management.
•Strong interpersonal communication skills for collaboration with internal and external stakeholders.
Company Confidential - Cambridge, MA
Full-Time - Permanent
Position Summary:
Genepool Networks has an exclusive opportunity for an exciting Head of Biometrics role with a clinical-stage biotech focused on novel immuno-oncology technology. Our well-funded client is building a passionate and skilled team supporting a growing pipeline. Reporting to the Chief Development Officer, this role offers extensive career growth and the opportunity to work closely with a seasoned leadership team. The successful candidate will have experience leading and building a team supporting oncology programs across all phases of development.
Required Qualifications:
•Ph.D. or master’s degree in Statistics, Biostatistics or related discipline
•At least 8-10 years of biotechnology or pharmaceutical industry experience industry in oncology clinical development; immuno-oncology (I/O) experience highly preferable
•Experience handling data management and statistical programming components
•Ability to consult with scientific investigators, interpret research requirements, and determine statistical analysis strategies
•Provide high-level updates and advice to senior management, including evaluation and interpretation of clinical trial study design and its potential impact on programs and clinical / regulatory strategy
•Represent company as the senior statistical executive for Health Authorities (e.g., FDA, EMA, NMPA, etc.) and participate in all regulatory meetings for clinical programs and interactions with Health Authorities
•Monitor all external data management functions and monitor work of all internal and external bio-analysts and programmers
•Comprehensive expertise and demonstrated experience in drug development of all phases and approvals
Company Confidential - Boston, MA
Full Time
The Opportunity
The Research Engineer will work with a multidisciplinary start-up team as a dedicated optics expert, developing cutting edge clinical diagnostics tools.
Key Responsibilities
The Research Engineer’s focus is applying advanced microscopy techniques to design custom optical microscopes. Here you will also expand your expertise into building microfluidics systems, creating and deploying methods for automated data collection, and developing system controls in support of product development while maintaining awareness of emerging technologies in the broader market
The Person
● Has a bachelor’s or master’s degree in electrical engineering, optics, applied physics, biophysics, or a related field with 3-7 years of industry experience, or a PhD in similar fields with 1+ years of industry experience
● Has prior hands-on experience designing and evaluating advanced imaging systems, such as high-content, high speed fluorescence, and phase-contrast microscopy
● Is skilled in the automation and development of scientific instrumentation that involves lasers, LEDs, optics, electronics, microfluidics, and mechanical sub-assemblies
● Is practiced in automated data acquisition and image analysis (using Python or C/C++).
● Is a productive oral and written communicator who readily establishes rapport with technical and non-technical audiences alike
● Can provide examples success in troubleshooting/problem solving
● Is legally authorized to work in the US on an indefinite basis
Location
The position is primarily based in Boston, MA. Candidates must be willing and able to commute to the Boston area for onsite responsibilities and authorized to work in the US indefinitely.
Company Confidential - Boston, MA
Full Time - Permanent
A well-funded biotechnology company based in Boston, specializing in small molecule drug discovery seeks a VP of Biology to advance preclinical programs toward clinical development.
The Opportunity
The company is seeking a highly experienced Vice President of Biology to lead its scientific efforts and drive the development of innovative small molecule therapeutics. The ideal candidate will have a proven track record in advancing multiple preclinical programs into clinical stages, with a strong background in molecular biology, drug discovery, and translational medicine.
Key Responsibilities
Leadership and Strategy:
Program Development:
Clinical Translation:
Cross-functional Collaboration:
Scientific Excellence and Innovation:
The Person
Location
This position is based in Boston, MA. Candidates must be willing to relocate or commute to the Boston area.
Company Confidential - Somerville, MA
Full Time
The Opportunity
The Community Operations Coordinator will support the operation of a world class biotechnology and life sciences incubation platform. Resident companies within the incubator grow rapidly, efficiently, and cost-effectively - accelerating biotechnology innovation for patients with unmet need. You’d be joining the organization’s well-established operations team that makes all of this possible! As a people-facing go-getter who facilitates success, we believe you could be a valuable contributor to this mission.
Key Responsibilities
Your role includes organizing biotech networking events, ensuring the office spaces are welcoming and functional, onboarding new resident companies, and building strong relationships with our resident companies and partners.
Office Management:
● Greet visitors, guests, and vendors professionally and manage sign in
● Coordinate with janitorial staff to ensure cleanliness of common areas, offices, meeting rooms and lab suites
● Update and manage tenant information in relevant databases
● Collect feedback on amenities and office operations to implement improvements
● Troubleshoot minor office equipment issues and escalate as needed
● Keep the kitchen organized and well-stocked, including coffee machine maintenance
● Monitor and restock office supplies and consumables
● Administratively assist CEO and other team members with operations
Event Planning:
● Organize monthly events, including networking happy hours, lunch and learns, larger gatherings, etc.
● Manage event logistics, timelines, budgets, and coordination
● Capture photos and videos to promote events and community culture on social media
● Coordinate joint events with our partners by managing communication and ensuring alignment on goals and logistics
Resident Engagement:
● Greet and orient new residents, providing an overview of community amenities, resources, and policies
● Assist with move-in paperwork, including access cards, keys, and security protocols
● Serve as the primary liaison between residents and the operations team, addressing inquiries and ensuring prompt resolution of issues
● Log resident requests, track maintenance issues, and provide regular updates to the operations team
● Oversee resident offboarding, collect feedback through closeout interviews, and maintain relationships with former residents
● Manage mail and package sorting, ensuring timely delivery and handling any receiving/sending needs
The Person
● Is a go-getter with strong communication, interpersonal, and organizational skills
● Has prior experience in event planning or office coordination
● Is proficient in Microsoft Office, ideally with exposure to Canva as a plus
● Is adaptable, friendly, and able to manage multiple priorities
● Must have a car for travel between Somerville and Cambridge locations
● Authorization to work in the US
● Is willing to showcase an idea for the first event you'd like to plan for our biotech residents as part of the interview process
Location
The position is primarily based in Somerville, MA. Candidates must be willing and able to commute to the Boston area for onsite responsibilities and authorized to work in the US indefinitely.
Company Confidential - San Francisco Bay Area, CA
Full Time - Permanent
The Opportunity
An innovative biotechnology company in the Bay Area utilizing natural product chemistry to address unmet patient need is seeking a Principal Scientist specializing in medicinal chemistry to initiate new drug discovery projects, and to follow through with molecule optimization strategies. Responsibilities range from launching projects to contributing to IND filings. The right hire will come from a cross-functional setting and approach this role with a blend of technical prowess and leadership influence - helping to guide a team of medicinal chemists in designing and synthesizing development candidates for clinical testing.
Key Responsibilities
• New drug candidate/synthetic route design
• Management of internal and external chemists, especially direct reports on the medicinal chemistry team
• Serve as medicinal chemistry team lead on collaborative drug discovery projects
The Person
•PhD in Synthetic Organic Chemistry, Medicinal Chemistry, or related field
•7+ years biotechnology or pharmaceutical industry experience
•History of success leading teams and advancing projects in a collaborative environment
Location
The position is based in Menlo Park, CA. Candidates must be willing and able to commute to the company for onsite responsibilities.
Company Confidential - Cambridge, MA
Full-Time - Permanent
Position Summary:
Genepool Networks has an exclusive opportunity for a newly created Regulatory Affairs role with a clinical-stage biotech focused on novel immuno-oncology technology. Our well-funded client is building a passionate and skilled team supporting a growing pipeline. Reporting to the Chief Development Officer, this role offers extensive career growth and the opportunity to work with a seasoned regulator. The successful candidate will have experience supporting oncology programs across all phases of development.
Required Qualifications:
•More than 10 years of biotechnology or pharmaceutical industry experience
•Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, and product lifecycle management
•Provide leadership on regulatory interactions and negotiation with global regulatory agencies/authorities
•Excellent writing, interpersonal communications, organizational, and presentation skills
•Detail-oriented and collaborative
Preferred Qualifications:
•Experience supporting Immuno-Oncology programs
Company Confidential – Menlo Park, CA
Full Time - Permanent
The Opportunity
An innovative biotechnology company in the Bay Area utilizing natural product chemistry to address unmet patient need is seeking an Associate Director specializing in medicinal chemistry to initiate new drug discovery projects, and to follow through with molecule optimization strategies. Responsibilities range from leading direct reports and launching projects to contributing to IND filings. The right hire will come from a cross-functional setting and approach this role with a blend of technical prowess and leadership influence - helping to guide a team of medicinal chemists in designing and synthesizing development candidates for clinical testing.
Key Responsibilities
• Apply strategic practices and mindset to advance company’s pipeline
• New drug candidate/synthetic route design
• Management of internal and external chemists, especially direct reports on the medicinal chemistry team
• Serve as medicinal chemistry team functional lead on collaborative drug discovery projects, communicating program progress to an array of stakeholders
The Person
•PhD in Synthetic Organic Chemistry, Medicinal Chemistry, or related field
•7+ years biotechnology or pharmaceutical industry experience
•History of success leading teams and advancing projects in a collaborative environment
Location
The position is based in Menlo Park, CA. Candidates must be willing and able to commute to the company for onsite responsibilities.
Company Confidential - Cambridge, MA
Full-Time - Permanent
Position Summary
•Our well-funded, Series A client seeks a Chief Medical Officer (CMO) to join its growing team. The lead program is poised to become a first and best in class therapeutic and will enter Phase I trials later this year. With a seasoned leadership team, board, and investor syndicate this is a high impact role that demands a visionary leader.
Responsibilities:
•Build and develop a broad set of functions (including Regulatory, Clinical Operations, Clinical Development, Medical Affairs, Biostats and Pharmacovigilance teams) and lead all aspects of the organization’s Phase I - Phase III clinical drug development initiatives.
•Provide internal medical expertise and support during clinical study design, study participant safety, and protocol development.
•Participate in Board and SAB meetings, including organization of the clinical advisory board.
•Design strategy for use of external consultants, CROs or other service providers.
•Successfully represent the company’s clinical programs, strategic vision and data to key opinion leaders, investors, corporate partners, Board of Directors, and other key stakeholders.
•Manage the presentation of scientific data to regulatory authorities and appropriate scientific groups.
•Represent the company in partnering activities, presentations, due diligence, and potential in-licensing and out-licensing activities.
•Act as the primary public medical face at major industry conferences, maintaining awareness of cutting-edge developments and promoting the company's interests.
•Support the CEO in articulating and advocating for the company's pipeline to financial markets, scientific, and medical communities.
Qualifications and Experience:
•Board certified MD or MD/PhD in Neurology (preferred) and respected as a patient-focused clinician with relevant industry experience in a rapidly growing, high-science biotech setting.
•15+ years of experience in the biopharma industry, including neurology company experience.
•Preference given to those with commercial experience.
•Demonstrated expertise in drug development strategy and implementation, pipeline assessment and asset allocation with neuro diseases.
•Experience with developing novel clinical trial designs, bringing innovative concepts from ideation through creation.
•A track record of translating novel mechanism of action small molecule drugs through precision medicine approaches in relevant patient sub-populations.
•Past success forging and nurturing key partnerships and collaborations with the external scientific and medical communities (academia, regulatory bodies, and other stakeholders), and a robust personal network of outside experts, consultants, and service providers.
•Understands how to create and maintain high-performing teams that achieve corporate milestones, working collaboratively with Executive Leadership, and supporting a culture of accountability and transparency.
•Adaptability and experience scaling the company and maximizing limited resources to achieve successful outcomes.
•Deep understanding of neurology marketplace and scientific literature.
•Strong interpersonal communication skills for collaboration with stakeholders.
•Personal characteristics include building authentic relationships, strategic thinking, leadership in managing organizational growth, integrity, and accountability.
Company Confidential - Cambridge, MA
Full Time - Contract (with Potential to Convert)
The Opportunity
Our private, clinical-stage small biotech is seeking a Formulations and Analytical Method Development nanomedicine subject matter expert to advance their discovery and preclinical programs. A strong background in relevant drug delivery systems, experience with relevant characterization techniques, and a track record for troubleshooting stability and quality issues are key qualifiers for this fantastic opportunity to contribute to the company's innovative platform.
Key Responsibilities
• Drive nanoparticle formulation efforts for discovery and preclinical studies
• Ability and willingness to run experiments both independently and collaboratively
• Characterize polymers, drug substance and nanoparticles using standard analytical techniques
• Highlight potential stability and performance issues with formulations
• Contribute cross-functionally with adjacent teams' workflow to develop/screen nanoparticles
• Foster relationships with CROs to for animal studies and material supply needs
• Contribute to CMC objectives like drug product manufacturing, batch record evaluation, and regulatory filings
• Maintain lab equipment and consumable supply levels
The Person
•PhD or MS in Materials Science, Polymer Chemistry, Chemical Engineering or related field
•2+ years biotechnology or pharmaceutical industry experience
•Experience with nanoparticle formulation development: especially polymeric nanoparticles
•Hands on practice with microfluidics, evaporation techniques, TFF, sterile filtration, and sterile dosage
•HPLC method development knowledge and experience is helpful
•History of success in a collaborative environment with R&D and CMC teams
Location
The position is based in Cambridge, MA. Candidates must be willing and able to commute to the Boston area for onsite responsibilities, and authorized to work in the US indefinitely
Company Confidential
Boston, MA
Full-Time
Genepool Networks has an exclusive opportunity for a highly motivated and driven Associate Scientist of Gene Therapy Payload Platform Development to join a growing R&D team for an in-vivo gene editing company. In addition to contributing to sample testing and method development, the role includes running routine assays and creative input developing both R&D and release assays.
In this role, you will utilize diverse molecular cloning tools to generate, design and create novel viral vectors constructs while developing molecular tools and systems critical to the company's core platform.
The right hire will be someone detail-oriented, highly organized, and determined to become an integral part of a company moving novel gene therapies into the clinic, revolutionizing the reach and access of the curative power of genomic medicines for patients with serious diseases.
Responsibilities:
•Perform molecular cloning to generate DNA constructs for proprietary viral vectors utilizing a multitude of DNA assembly techniques including Gibson, Golden Gate, Gateway cloning techniques
•Purify plasmid precursors for viral production workflows
•Utilize long-read DNA sequencing and in silico tools to validate cloning and plasmid preparation
•Complete laboratory experiments in timely and organized fashion
•Produce and maintain complete and accurate experimental records. Including use of LIMS-like systems within the Benchling environment such as inventory and workflows
•Analyze, interpret and report experimental findings to the research group and other key stakeholders
•Collaborate with multi-disciplinary teams to advance our intellectual property, drug development and company growth
•Other duties and responsibilities as assigned
Qualifications:
Required
•Bachelor’s Degree or Master’s Degree in Biology, Biochemistry, Bioengineering, Chemical Engineering or a related scientific discipline; post-graduate experience preferred
Preferred
•Demonstrated proficiency with molecular cloning methods including cloning, bacterial culture, and/or nucleic acid isolation
•Experience with in silico DNA sequence manipulation and analysis software (MacVector, SnapGene, Benchling, etc.)
Company Confidential
Boston, MA
Full-Time
Genepool Networks has an exclusive opportunity for a highly motivated and driven Associate Scientist of Analytical Development to join a growing Chemistry, Manufacturing, and Controls (CMC) team for an in-vivo gene editing company. In addition to contributing to sample testing and method development, the role includes running routine assays and creative input developing both R&D and release assays.
This is an opportunity to get involved in a wide variety of Analytical Development tasks, including assay development, troubleshooting, and method optimization to assess and characterize viral vectors. You will play a significant role in advancing a novel gene therapy drug candidate into the clinic.
Responsibilities:
•Conduct routine laboratory assays in support of dPCR- and qPCR- based workflows independently
•Provide regular updates in writing and via presentations
•Contribute to method development discussions and implementations as needed
•Maintain accurate records, including writing technical reports detailing procedures, outcomes, and data analysis. Review experiments and studies performed by team members
•Communicate with cross-functional team members to route samples and assess output as needed.
•Other duties and responsibilities as assigned
Qualifications:
Required
•Bachelor’s Degree or Master’s Degree in the Life Sciences such as Biology, Cell Biology, Molecular Biology, Biochemistry, or related field with experience in biotechnology, pharmaceutical, or academic settings
•Experience reading and following PCR-based methods; ability to perform routine testing using manual and automated laboratory instrumentation
•Knowledge and ability to apply relevant techniques and problem-solving skills as an individual and part of a team to overcome experimental challenges
Preferred
•Experience with quantitative dPCR and qPCR; additional laboratory techniques, such as ELISA, flow cytometry, HPLC and laboratory automation
•Academic understanding of laboratory assays and the skill to communicate challenges encountered in the laboratory
•Knowledge of software packages to evaluate analytical outputs and familiarity with statistical analyses relevant to an analytical laboratory environment
Genepool Networks is an equal opportunity employer. All qualified applicants will
receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or veteran status.
We encourage applications from candidates of all backgrounds and experiences.
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