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Our On-Demand Talent Solutions team is partnering with our trusted client to identify a Director-level Clinical Scientist. Our client is a biopharmaceutical company developing next-generation targeted therapies for cancer. This role is ideal for a drug development professional passionate about translating innovative science into meaningful clinical outcomes. Summary: The Clinical Scientist will lead aspects of protocol development, study planning, data generation, analysis, and reporting as well as work cross-functionally to deliver high-quality data and insights that move programs forward. Responsibilities: • Lead design and execute clinical deliverables to support the CDP, including INDs, protocols, IBs, and study documents (CRFs, SAPs, data listings)., • Oversee clinical data generation, validation, and review, including query resolution, patient eligibility, and protocol deviation management., • Perform study subject-level data analysis to inform clinical development strategy and reporting., • Partner with medical teams, advisors, and Health Authorities, including support for HA/IRB interactions and responses., • Contribute to therapeutic area research, KOL/investigator engagement, and development of scalable clinical processes. Qualifications: • A minimum of 8 years of relevant experience and an advanced degree (PharmD, MD, MSN, PA, MPH, etc.), • Strong background in small molecule therapies and oncology clinical development., • Experience in early phase clinical trials.

This clinical-stage biotechnology company is changing the treatment of cancer with their novel therapeutic platform. They are seeking a Senior Vice President of Regulatory Affairs to oversee all regulatory activities and be their primary strategic advisor on global regulatory strategy. You will proactively shape development strategy, lead health authority engagements, and oversee a small Regulatory team. This company offers innovative science, a collaborative and fun company culture, and flexible work arrangements. With multiple programs in Phase 1 trials, now an exciting time to join this growing organization! Responsibilities: • Own and lead global regulatory strategy for the company’s oncology portfolio, including health authority engagement strategy, expedited pathway opportunities, and lifecycle planning., • Serve as the primary regulatory strategy advisor for the regulatory function; proactively influence program strategy and key development decisions by bringing forward options, tradeoffs, risks, and recommendations., • Drive a proactive regulatory operating rhythm across programs (decision calendar, scenario planning, and risk mitigation) with a “no surprises” approach., • Provide key updates and guidance on regulatory strategy, risks, and deliverables to the Executive Team and Board of Directors, as needed., • Serve as primary contact with FDA and other regulatory agencies, leading communications and meetings, and representing the company with executive-level presence., • Direct and negotiate submissions (IND, CTA, NDA, BLA, MAA, etc.) with regulatory authorities., • Strategize, lead, write, and/or supervise the development and submission of documents/dossiers to achieve development goals; ensure on-time, high-quality, regulatory-compliant submissions., • Build, lead, and manage the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the company., • Provide strategic direction to all Regulatory functions including hiring, mentoring, and leading staff; build scalable infrastructure and a high-performing team., • Build key infrastructure (processes, best practices, SOPs) to support development, potential approvals, and commercialization readiness., • Forecast budgets and develop department best practices and SOPs., • Provide regulatory leadership and support to project/program teams and senior management for all aspects of the development program., • Contribute to overall product development strategy and manage development, monitoring, and delivery of regulatory project plans throughout the lifecycle., • Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the U.S. and globally. Qualifications: • Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred., • A minimum of 20 years of Regulatory Affairs experience in the biopharmaceutical industry., • Must have extensive Regulatory experience with oncology programs (5 or more years in oncology)., • Experience with biologics programs is preferred., • A track record of successful interaction with FDA and other regulatory agencies., • Experience supporting both early and late phase development, including development and filing of associated regulatory submissions., • Ability to review, understand and explain the regulations and guidance documents to guide project teams., • Experience filing successful marketing applications (NDA, BLA or MAA). Prior successful drug approvals a plus., • Experience with Orphan Drug Designations, Fast Track, Accelerated Approval, Breakthrough Therapy, and/or Priority Review protocols., • In-depth understanding of the drug development, product commercialization and life cycle management processes., • Ex-US or global regulatory experience required., • Must be an executive-level communicator with strong written/oral skills; able to translate complexity into decision-ready recommendations., • Strong cross-functional leader who can influence effectively internally and externally and drive alignment in a matrixed organization., • Comfortable wearing many hats in a small biotech environment while setting a high bar for rigor, accountability, and quality., • Ability to drive meetings with senior stakeholders, regulatory agencies, and project teams., • Previous Regulatory team leadership experience required., • Demonstrated ability to lead at the function-head level (building teams, setting strategy, and driving accountability in a highly cross-functional environment). This is an onsite position in the San Francisco Bay Area (3 days per week). NOTE: Our client prefers local candidates in the SF Bay Area. Those elsewhere on the West Coast, or those willing to relocate to the Bay Area, may be considered. The budgeted salary range for this position is $300,000 to $420,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

We are seeking a Senior Medical Director to lead late-stage clinical development programs in Oncology, including pivotal Phase III trials and registration-enabling studies. This individual will play a key role in shaping and executing clinical strategy, serving as Medical Monitor, supporting regulatory submissions and commercialization efforts, and partnering cross-functionally to advance oncology assets successfully. This position is based onsite in the South San Francisco, CA or Cambridge, MA area. Key Responsibilities Clinical Trial Leadership: Provide medical leadership for the design and execution of late-stage clinical trials, including pivotal and confirmatory studies. Partner closely with Clinical Operations to ensure studies are conducted in alignment with scientific objectives, patient safety standards, and regulatory requirements. Medical Monitoring: Serve as Medical Monitor for Phase III and registration trials, ensuring patient safety, protocol compliance, and timely medical oversight. Review safety data, support data monitoring activities, and act as a primary medical contact for study teams and investigators. Clinical Strategy: Contribute medical and scientific leadership to clinical development strategy, regulatory submissions, and lifecycle planning across oncology programs. Cross-Functional Collaboration: Work closely with Regulatory Affairs, Clinical Operations, Pharmacovigilance, Biostatistics, Medical Affairs, and Commercial teams to align clinical execution with broader business objectives. External Engagement: Represent the organization in interactions with investigators, key opinion leaders, regulatory authorities, and external collaborators. Data Analysis & Interpretation: Analyze clinical trial data and real-world evidence to identify trends, assess efficacy and safety signals, and support data-driven decision-making. Translate findings into actionable insights that inform clinical strategy, regulatory submissions, and program advancement. Lifecycle Management: Support strategies for label expansion, post-marketing commitments, and long-term product differentiation. Regulatory Support: Lead preparation of regulatory documents, participate in global health authority interactions, and contribute to risk management planning throughout the development lifecycle. Business Development Support: Provide clinical expertise for licensing opportunities, partnerships, and due diligence activities. Stakeholder Leadership: Build strong cross-functional relationships, challenge ideas constructively, and drive decisions grounded in scientific evidence. Scientific Leadership: Maintain a current understanding of oncology trends, the competitive landscape, and regulatory developments to inform program strategy. Additional Requirements: Ability to work across multiple time zones and travel up to 30%. Qualifications Required • MD with board certification in Oncology, Hematology-Oncology, or a related specialty, • At least 5 years of clinical development experience, with a focus on late-stage oncology trials Preferred • Proven track record as a Medical Monitor for pivotal trials and successful regulatory submissions, • Deep understanding of oncology drug development, clinical endpoints, and regulatory pathways, • Demonstrated ability to lead cross-functional teams and manage complex clinical programs, • Prior clinical practice experience or experience as an investigator is a plus, • Strong leadership, strategic thinking, and communication skills, • Excellent collaboration skills with both internal and external stakeholders, • Demonstrated commitment to high ethical standards and professional integrity

NO THIRD PARTIES Position Summary A clinical-stage biotech company based in the Bay Area is seeking a Senior Statistical Programmer to provide long-term contract support. The organization is focused on the development of oncology therapeutics, and with a growing pipeline, the programming team requires additional senior-level expertise. This role will specifically focus on CDISC SDTM standards, requiring deep, hands-on experience in SDTM mapping and implementation for oncology clinical trials. The ideal candidate will be a subject matter expert in SDTM who can lead dataset development efforts, ensure regulatory compliance, and provide technical guidance to cross-functional teams. Key Responsibilities • Lead the development, mapping, and implementation of CDISC SDTM datasets for oncology clinical studies., • Translate raw clinical data into compliant SDTM domains according to CDISC standards and sponsor requirements., • Develop and maintain SDTM specifications and mapping documentation., • Perform hands-on SAS programming to create, validate, and quality control SDTM datasets., • Ensure SDTM deliverables are submission-ready and compliant with regulatory standards., • Collaborate with Biostatistics, Data Management, and Clinical teams to resolve data and mapping issues., • Review CRFs, CRF annotations, and protocols to ensure accurate SDTM mapping., • Support regulatory submissions and respond to data-related queries as needed. Top Requirements • 10–15+ years of statistical programming experience in clinical research, preferably with small to mid-sized sponsor companies, • Extensive expertise in CDISC SDTM standards with strong hands-on SDTM mapping and implementation experience for oncology trials, • Oncology experience required, with solid tumor experience strongly preferred (RECIST criteria), • Advanced SAS programming skills with a focus on SDTM dataset creation and validation., • Experience preparing SDTM datasets for regulatory submissions (e.g., FDA/EMA)., • Ability to work independently and serve as an SDTM subject matter expert within the programming team., • Excellent communication skills and ability to collaborate effectively in a cross-functional environment.

Job Description Title: Business Development Professional: Manager to Director, based on experience Services: Chemistry Business Location: US based (remote – WFH), MA, CA, NJ Position: Full-time Compensation: competitive salary, commission and generous benefits Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary These positions will focus on supporting Frontage Chemistry Service growth. Frontage Chemistry have research sites in both China and US, can provide one-stop-shop service from discovery to commercial production in drug studies. Role & Responsibilities • Develop, collaborate and execute business development plans for the assigned services., • Design and build a BD team to support chemistry business growth in both China and US and reach or exceed sales targets., • Ability to sell either end-to-end packages or individual service and the ability to cross sell., • Develop client relationships/accounts and prospects for potential clients., • Solicit and develop new business opportunities through direct selling, referrals, trade shows, conferences, meetings etc., • Participate in industry trade shows, conferences and other events., • Promptly respond to new leads and coordinate with internal support teams where necessary., • Identify decision-makers and areas of service needs, qualify, pursue, negotiate and close deals., • Keep accurate records of calls, meetings and other related activities in CRM., • Develop and maintain an up-to-date pipeline of new business opportunities., • Assist with preparing proposals, quotes, and customer contracts., • BS or MS in chemistry, medicinal chemistry or related area. PhD would be preferred., • 5-10 years of Business Development experience in the biotech, pharma or CRO industry., • Significant experience and the knowledge of chemistry CROs in China., • Extensive experience in providing services to biotechnology companies with small molecule pipelines and small nucleic acid pipelines., • Proven track record in providing research services based on full-time equivalents (FTEs) and fee-for-service (FFS) solutions., • Strong background in chemistry CDMO services, including kilogram-scale production of drug intermediates and regulated starting materials (RSMs)., • Ability to support clients across all development phases., • Solid knowledge of CRO, Biotech and Pharma industries with a grasp on both GMP and GMP-like productions., • Understanding the small molecule synthesis business models, and familiarity with the U.S. client landscape., • Ability to assess business leads and value, craft recommendations through effective written and verbal communication in English, work with scientific and the marketing teams, and close deals., • Strong knowledge, skills and the capability in proposal writing, contract negotiations and project management., • Excellent presentation, analytical, selling, negotiation and closing skills., • Excellent organization, time management, customer orientation and planning skills. Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job Description Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development. We have developed an innovative liquid biopsy technology that is empowering biopharma partners in clinical drug development and oncology medicine research. Our international business services provide molecular insights to the top 10 MNC BioPharma’s to support biomarker-driven clinical trials in US, EU, APAC including China. We believe our most important asset is our people and are dedicated to maintaining a thriving workplace. We value a culture of Integrity, Innovation, Quality, Respect, Courage, Collaboration, Caring, and Communication. We are seeking a highly skilled and motivated Sr. Automation Engineer ( Laboratory) with expertise in Next-Generation Sequencing (NGS) to join our dynamic team. In this role, you will play a critical part in developing, optimizing, and automating workflows to advance our NGS capabilities. As an integral member of our team, you will work closely with cross-functional groups to enhance the efficiency, scalability, and precision of our sequencing technologies. If you have a passion for automation, NGS, and cutting-edge technology, we invite you to contribute to our innovative and fast-paced environment. Key Responsibilities: • Design, develop, and implement automated liquid handling systems for NGS assays, • Translate and optimize manual processes onto automated platforms, • Provide training and technical support for operations during deployment of new methods, • Author and update SOPs (Standard Operating Procedures) and quality documentation to ensure compliance with industry standards., • Maintain and manage instrument configuration documentation (IQ/OQ/PQ and SOP)., • Bachelor’s degree in Engineering, Biotechnology, Biology or related field., • 3+ years of laboratory automation engineering experience required., • Strong Experience in programming and developing automated systems for assay development on Hamilton using Venus Software, experience with scheduling software., • Familiarity with lab automation tools, instrumentation (e.g., Agilent, Bio-Rad, Thermofisher), and software (e.g., BIOlims)., • Familiarity with barcoding, labware management, and traceability tools., • Experience in process development and scaling in a laboratory and/or manufacturing environment., • Ability to work cross-functionally with IT, Facilities, and Operations teams., • Strong problem-solving and troubleshooting skills., • Excellent communication skills and the ability to document technical processes clearly., • Experience with technology transfer and vendor management. Employee benefits include comprehensive medical, dental and, vision, for eligible employees and their dependents. Other benefits include stock allocation and 401k matching benefits, 4 weeks of sabbatical after 5 years of service, lunch provided daily for onsite employees. Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. Predicine has developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The company has launched a portfolio of blood-urine- and tissue-based diagnostic assays for oncology. We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. All job offers are contingent upon successful completion of background verification. Applicants must be legally authorized to work in the USA without sponsorship. *

Job Description Director, Operation/Business Development, DMPK/GDSS Services Location(s): Home based in California, San Francisco Reports to: Executive Director, Business Development Frontage Laboratories: Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. DMPK/Global Drug Discovery Service: At Frontage, our scientific staff applies state-of-the-art techniques and best-in-class approaches to generate data for critical milestones and decision-making during drug discovery and development. The highly trained and experienced team provides broad and in-depth expertise/advice to clients on appropriate study designs, execution of studies, and interpretation of the data. We offer extensive drug metabolism and pharmacokinetic capabilities for new chemical entities and compounds in development. We provide rapid turnaround of high-quality key data sets to support critical decisions in advancing potential therapeutic agents for further development. Responsibilities: • This is a hybrid business development and operations position to facilitate expansion of Frontage’s DMPK/ Global Drug Discovery services in USA/China. Focus on selling DMPK and early drug discovery services for pharmaceutical and biotech companies, • Develop and maintain account and action planning activities to facilitate partnerships with prospective clients, • Develop and maintain a personal client call cycle to expand client base and realize opportunities to meet and exceed sales objectives, • Participate in the business development activities through assisting in proposal/protocol/report writing and managing, especially IND-enabling, DMPK studies for clients, • Work closely with the operations team and provide other support as needed to facilitate the business growth, • Recognize and communicate sales opportunities to other Frontage business units Requirements: • BS/MS degree or above, experience in DMPK/drug development highly desirable, • 3-10 years’ working experience of sales or project management in DMPK/drug discovery division of a pharmaceutical or a CRO company., • Excellent interpersonal and communications skills required, • Very strong work ethic and comfortable with travel Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job Description Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development. We have developed an innovative liquid biopsy technology that is empowering biopharma partners in clinical drug development and oncology medicine research. Our international business services provide molecular insights to the top 10 MNC BioPharma’s to support biomarker-driven clinical trials in US, EU, APAC including China. We believe our most important asset is our people and are dedicated to maintaining a thriving workplace. We value a culture of Integrity, Innovation, Quality, Respect, Courage, Collaboration, Caring, and Communication. We are seeking a highly skilled and organized NGS Lab Project Manager to join the Lab Service Management team. The ideal candidate will have a strong background in molecular biology, and project coordination with NGS workflow experience, to support projects in the Predicine NGS Operations portfolio. What you will get to do: • Project Management:, • Oversee the planning, execution, and delivery of NGS-based projects, ensuring alignment with project timelines, budgets, and resources., • Develop detailed project plans, outlining milestones, deliverables, and responsibilities., • Coordinate with cross-functional teams (scientists, bioinformaticians, quality control specialists) to ensure seamless execution of NGS workflows., • Communicate progress and timelines towards company goals through daily and weekly updates., • Manage project risks and resolve any issues or bottlenecks that arise., • Document and track projects using systems such as JIRA, Confluence, or other PM-related software., • Client and Stakeholder Communication:, • Serve as the primary contact for clients regarding project updates, timelines, and outcomes., • Provide regular reports on project progress, including data analysis, and prepare presentations for internal and external stakeholders., • Manage expectations and resolve any concerns related to project timelines or deliverables., • Data and Quality Assurance:, • Ensure data quality, accuracy, to maintain high standards of quality control., • Support troubleshooting efforts for any discrepancies in data., • Documentation and Compliance:, • Maintain accurate project documentation, including protocols, project timelines, and client communications., • Ensure compliance with all regulatory and ethical standards, including relevant industry guidelines for NGS applications., • Education:, • Bachelor’s degree in molecular biology, Genetics, Biochemistry, or a related field. A Master's or PhD (Preferred), • Experience:, • Minimum of 2 years of experience managing NGS-related projects or laboratory operations, with a proven track record in project management., • Skills:, • Strong organizational, communication, and problem-solving skills., • Proven ability to manage multiple projects simultaneously in a fast-paced environment., • Proficient in project management tools (e.g., Microsoft Project, Asana, Jira) and basic office software (e.g., Microsoft Office Suite, Google Workspace)., • Certifications: Benefits: We offer a competitive salary, comprehensive benefits, and opportunities for professional growth and development. Employee benefits include comprehensive medical, dental, vision, for eligible employees and their dependents. Other benefits include stock allocation and 401k benefits, 4 weeks sabbatical after 5 years of service, lunch provided daily for onsite employees. Our Opportunity Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. Predicine has developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The company has launched a portfolio of blood-urine- and tissue-based diagnostic assays for oncology. We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. All job offers are contingent upon successful completion of background verification. Applicants must be legally authorized to work in the USA without sponsorship. *

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