Director, Clinical Science
Director, Clinical Science San Diego, CA - Hybrid $200,000 - 230,000 The Director of Clinical Science will lead and contribute to the design and execution of clinical studies in oncology. This role involves partnering with clinical operations, translational teams, and other team members to develop and refine clinical plans, author key clinical and regulatory documents, and ensure the delivery and interpretation of clinical data. The Director will also drive study enrollment and build collaborative relationships with investigators, clinical site staff, CROs, and colleagues. A proactive and thoughtful approach to clinical study execution is essential, with a focus on anticipating and resolving obstacles. Key Responsibilities: Lead and contribute to study design and amendments in collaboration with internal and external scientific stakeholders. Collaborate with MDs, regulatory partners, and other stakeholders to author and submit protocols, amendments, regulatory filings, and other documentation. Work with clinical operations, data management, and CROs to develop and implement data quality plans, and lead internal medical data review and safety trend analysis for studies/programs. Serve as the point-of-contact for clinical inquiries from CRO medical monitors and other stakeholders. Develop and provide input for clinical presentation slides and materials for internal/external meetings and communications (e.g., investigator meetings, site selection visits, training sessions, newsletters). Partner with clinical operations and CROs to develop and maintain study start-up documents/resources (e.g., ICF, Lab Manual, EDC, Safety Monitoring Plan). Participate in safety meetings, track, analyze, and review documentation for potential safety events. Lead and contribute to the development and implementation of communication strategies to support ongoing and concluded studies, including KOL interactions, advisory boards, medical meetings, congresses, publications, and other materials. Write and/or review abstracts, posters, and content for scientific meetings, conferences, and other events, and coordinate reviews with internal partners and stakeholders. Coordinate submissions to scientific meetings and other appropriate venues. Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and processes. Perform other duties as assigned. Qualifications: MS (or equivalent) required; PhD, PharmD, or MD preferred. Minimum of 5+ years of related experience with a PhD or equivalent degree; at least 2 years of experience in conducting/supporting oncology/hematology clinical studies. Excellent written and verbal communication skills. Expertise in interpreting immunology/immuno-oncology translational data and clinical data. If you are interested, please apply!
US$200000 - US$230000 per year
San Diego
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Genomics Scientist
Company Overview: EPM are partnered with a leader at the forefront of genomic research and innovation. Their mission is to harness the power of genomics to improve human health and advance scientific knowledge. We are a dynamic and collaborative team dedicated to pushing the boundaries of what is possible in the field of genomics. Job Description: The company are seeking a highly motivated and skilled Genomics Scientist to join their team in Amsterdam. The successful candidate will play a key role in the research and development efforts, contributing to cutting-edge projects that have the potential to transform healthcare. Key Responsibilities: Design and conduct experiments in genomics, including DNA/RNA sequencing, gene expression analysis, and genome editing. Analyse and interpret complex genomic data using bioinformatics tools and software. Collaborate with cross-functional teams to develop and implement innovative research strategies. Stay up-to-date with the latest advancements in genomics and related fields. Prepare and present research findings to internal and external stakeholders. Contribute to the writing of scientific publications and grant proposals. Qualifications: Master's in Genomics, Molecular Biology, Genetics, or a related field. Proven experience in genomics research, with a strong publication record. Proficiency in bioinformatics and data analysis tools (e.g., Python, R, Bioconductor). Experience with next-generation sequencing (NGS) technologies and genome editing techniques (e.g., CRISPR/Cas9). Strong analytical and problem-solving skills. Excellent communication and teamwork abilities. Ability to work independently and manage multiple projects simultaneously. Benefits: Competitive salary and benefits package. Opportunities for professional growth and development. A collaborative and inclusive work environment. Access to state-of-the-art facilities and resources. The chance to make a meaningful impact on the future of healthcare.
Negotiable
Amsterdam
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Director Clinical Science
Director Clinical Science Northern New Jersey Area (Hybrid) Salary: $200,000-230,000 + Bonus + Equity Our client is a cutting edge CAR-T who novel approach dramatically decreases the time and cost associated with manufacturing. This is a newly created position allowing you to get in on the ground floor and eventually build a team beneath you as their indications advance in development. This company has received substantial funding through a highly successful serious B round of funding this past year where they generated over $200 million. They also have a leadership team with multiple approvals under their belt. If you are looking to be at the forefront of revolutionizing the CAR-T cell therapy space don't hesitate to apply and learn more! Key Responsibilities: Offer scientific expertise during protocol development, study design, oversight of study conduct, and interpretation of study results through to the final study report. Collaborate with a multidisciplinary team including Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory, Project Management, Medical Affairs, and CMC to achieve and deliver program objectives. Participate in protocol feasibility assessments, site identification, and vendor evaluation. Partner with Clinical Operations to review vendor, CRO, and site scope of work, study budget, and plans or manuals related to study data, IVRS, central labs, etc. Assist in the preparation of abstracts, manuscripts, presentations, and materials for external meetings related to the assigned protocol(s) and/or clinical program. Contribute to the writing of documents to support study conduct and regulatory submissions, including protocols, investigator brochures, informed consent forms, training documents, and clinical study reports; lead authorship for laboratory and pharmacy manuals. Develop and deliver internal and external training materials and presentations, including site initiation visits. Analyze potential safety and efficacy trends in clinical trial data for the preparation of interim and final reports of clinical trial data for study documents (including CSRs, IBs, and DSURs). Engage with academic partners, collaborators, advisory board members, etc., as appropriate. Support the planning and conduct of study committee meetings (e.g., IDSMC), investigator meetings, and advisory boards, including contributing to presentations and minutes. Manage and mentor Clinical Scientists, including identifying responsibilities for which Clinical Scientists assume a lead or contributory role, and identify growth opportunities for Clinical Scientists within each project team. Implement best practices for Clinical Scientist contributions to all aspects of strategic development, protocol design and conduct, development of key supporting materials, study site and vendor interactions, and data analysis/presentation. Participate in leadership meetings within the Chief Medical Officer and Clinical Development organization to identify strategic and operational challenges and potential solutions and collaboration opportunities. Qualifications: Advanced Degree in Life Sciences (e.g., DNP, APRN, PA, or related medical field, PharmD, PhD) with 3 years of experience; will consider a Master's degree with a minimum of 5 years of related experience, or a Bachelor's degree with 8 years of related experience, or equivalent experience. Experience working on Oncology trials.
US$200000 - US$2300000 per year
Bridgewater
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AD Medical Writing
Responsibilities: Medical Writing Leadership: Serve as the medical writing lead on assigned projects, working closely with cross-functional teams on project strategies. Implement all activities related to the preparation of writing projects, coordinating review, approval, and finalization. Facilitate review meetings, negotiate deliverables with functional areas, and propose solutions to resolve issues during the writing process. Scientific Writing & Documentation: Prepare and author clinical trial protocols, investigator brochures, clinical study reports, patient narratives, and regulatory submission documents (e.g., INDs, NDAs, CTDs). Develop clear, concise, and scientifically accurate documents that communicate complex medical and scientific information to both expert and non-expert audiences. Ensure compliance with regulatory guidelines, industry standards, and company specifications. Collaboration & Communication: Work closely with clinical, regulatory, and medical affairs teams to ensure the timely delivery of high-quality documents. Engage with internal stakeholders to understand project requirements and align on expectations. Lead or contribute to meetings and presentations, offering strategic advice on writing-related matters. Review & Editing: Review and edit documents prepared by junior writers, ensuring consistency, clarity, and scientific accuracy. Project Management: Manage multiple writing projects simultaneously, ensuring deadlines and quality standards are met. Identify potential challenges in document preparation and proactively address them. Research & Analysis: Conduct in-depth literature reviews to gather relevant background information. Interpret complex data from clinical trials, laboratory studies, and medical research to present findings clearly and accurately. Regulatory Knowledge: Stay up-to-date with changes in regulatory requirements, guidelines, and industry trends. Ensure that all documents comply with the latest FDA, EMA, ICH, and other relevant regulatory requirements. Qualifications: BA or higher degree in life sciences, pharmacology, medicine, or a related field. A Master's or PhD is preferred. Minimum of 10 years of experience as a medical writer, with a focus on clinical, regulatory, or scientific writing in the pharmaceutical, biotechnology, or healthcare industries. Demonstrated experience in preparing regulatory documents and publications for submission to regulatory agencies (e.g., FDA, EMA). Evidence of medical writing career development desirable, such as certifications from the European/American Medical Writers Association or relevant training through Drug Information Association. Skills & Competencies: Strong understanding of clinical trial methodology and regulatory requirements. Excellent written and verbal communication skills. Proficient in Microsoft Word, Excel, Adobe Acrobat, and project management tools. Experience using document management software (e.g., SharePoint, Veeva). High attention to detail, with the ability to critically evaluate and edit scientific content. Ability to work independently and as part of a team, managing multiple priorities effectively. Preferred: Experience in writing for multiple therapeutic areas, including rare diseases and immunology. Knowledge of medical writing software (e.g., EndNote, Adobe Acrobat). Certification from AMWA or similar organizations, with a specialty in Editing/Writing or Pharmaceutical writing. Advanced understanding of drug development processes, biostatistics, clinical research concepts, and scientific principles related to nonclinical development and CMC. The company currently anticipates the base salary for the Senior Medical Writer role could range from $180,000 to $195,000, depending on the candidate's qualifications, education, experience, and geographical location. This position will also be eligible for an annual performance bonus, stock options, and a comprehensive benefits package.
US$180000 - US$220000 per year
San Francisco
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Sr. Medical Director Clinical Development
Medical Director/ Sr. Medical Director Clinical Development Greater Boston Area (Remote, but must be based in Boston) Compensation: $300,000-330,000 + Bonus + Equity Company Summary: We are partnered with an innovative ADC-focused biotech experiencing significant growth this year. Their unique approach utilizes previously inaccessible targeting molecules and novel payloads, positioning them as a leader in ADC development. They have two lead programs in Phase 1 targeting high-need solid tumors, with promising preclinical results. The leadership team is highly experienced, with the CMO having brought three novel drugs to market. They raised over $130 million in their series B last year and secured deals with major pharmaceutical companies worth over $1 billion. They are seeking a Clinical Development Leader for one of their Phase 1 assets. Primary Responsibilities: Lead the clinical development strategy for Phase 1 assets. Oversee the design, implementation, and execution of clinical trials. Collaborate with cross-functional teams to ensure alignment on clinical development goals. Provide medical and scientific expertise to support regulatory submissions and interactions. Build and maintain relationships with key opinion leaders and stakeholders in the oncology field. Contribute to the strategic planning and growth of the clinical development team. Monitor and analyze clinical trial data to ensure accuracy and integrity. Develop and manage clinical development budgets and timelines. Ensure compliance with all regulatory and ethical standards. Mentor and train junior clinical development staff. Represent the company at scientific conferences and industry meetings. Drive innovation in clinical trial design and execution to enhance efficiency and outcomes. Perform other duties as assigned. Ideal Qualifications: 2+ years clinical development experience MD or foreign equivalent. Oncology experience in industry
US$29000 - US$350000 per year
Boston
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AD Clinical Systems
We have a current opportunity for a AD Clinical Systems on a permanent basis. The position will be based in New Jersey and will require to be onsite 3x a week. For further information about this position please apply. Salary: $16,000-$180,000, 20% bonus, RSUs + additional benefits Summary: The Associate Director, Clinical Systems will support and develop capabilities for clinical data acquisition and standardization, increase efficiency of database builds, data visualization, and enable compliance to CDISC standards (e.g. CDASH, SDTM) while implementing industry best practices. We're seeking a candidate that is a technical Support leader with Veeva Clinical Vault expertise primarily with CTMS/eTMF. Expert in clinical systems and platforms (e.g. Medidata, Veeva CDMS, Veeva CTMS, CliqSense, JReview) configurations, capabilities, and system behaviors. Lead and deliver new capabilities, innovative technical solutions and/or clinical system integrations that enable future proof study execution. Provide technical leadership focused on technology enablement for EDC, Data Visualization, and other data collection / display systems Technical study lead to work with study team counterparts on study deliverables from external partners (e.g. Functional Service Providers, CROs, technology providers) performing data collection and data visualization services Oversee the build, maintenance, and deployment of study databases to collect clinical trial data, including configuring custom integrations Responsible for ensuring the activities required to build out standard objects (e.g., eCRF forms, edit checks, eCRF entry guidelines, standard data review reports) that are compliant with CDISC (SDTM) are implemented Collaborate with cross functional core roles (Data Managers, Medical Monitors, Statisticians, Programmers, etc.) Education and Experience: BS/BA degree in a relevant scientific discipline required. 8 years of experience in clinical systems execution and support, including EDC, data visualization, and data standardization preferred Minimum 5 years of experience leading process management and innovation
US$160000 - US$180000 per year
New Jersey
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Associate Director Of Clinical Development
We have a current opportunity for a Associate Director Of Clinical Development on a contract basis. The position will be based in Redwood City. For further information about this position please apply. Position Summary The Associate Director of Clinical Development will play a key role in planning and executing clinical trials while providing strategic input into clinical development programs. This position requires a combination of scientific expertise, project management skills, and leadership capabilities. Job Responsibilities Will report to a senior member of the Clinical Development team who has direct responsibility for the overall research strategy and clinical development activities for the urticaria and stem cell programs. - Will lead the design, implementation, and execution of clinical trials from Phase I-III -Will participate in and/or lead cross-functional matrix team meetings including stakeholders from clinical operations, medical affairs, regulatory affairs, and biostatistics. - Develop and review clinical trial protocols, informed consent documents, and other study-specific plans and essential study materials - Collaborate with study team, investigators and study sites to ensure trials are conducted according to protocol, GCP guidelines, and regulatory requirements - Monitor trial progress, timelines, and budgets while implementing risk mitigation strategies -Responsible for clinical aspects of data review and cleaning of key studies in the urticaria and stem cell programs. - Review and analyze clinical trial data, safety information, and study metrics -Generate study reports, presentations, and publications to communicate findings to internal and external stakeholders -Prepare and/or contribute to clinical study related and other regulatory documents (e.g. IBs, ICFs, SAPs, Data Management Plans, briefing books). Strategic Leadership - Contribute to clinical development plans and product development strategies - Provide scientific and medical expertise to cross-functional teams - Mentor and guide clinical research associates and other team members - Participate in the selection and management of CROs and vendors - Support regulatory interactions and documentation preparation Cross-functional Collaboration - Work closely with Clinical Operations, Biostatistics, Data Management, Medical Writing, Translational, Regulatory Affairs, Technical Operations and other functional teams to support successful execution of clinical development strategy - Engage with Key Opinion Leaders and clinical investigators - Lead strategy and authoring of clinical portions of regulatory submissions, responses to health authorities and ethics committees - Support business development activities as needed Qualifications Education and Experience - Advanced degree required (MD, PhD, PharmD, or equivalent) in a relevant scientific or medical field required - Minimum 5 years of clinical research experience, with at least 3 years in pharmaceutical/biotech industry -Experience in immunology is strongly preferred - Demonstrated experience in clinical trial design, implementation and execution with cross-functional study teams - Strong understanding of drug development processes, ICH-GCP guidelines and regulatory requirements Skills and Competencies - Excellent project management and organizational abilities - Strong analytical and problem-solving skills - Superior written and verbal communication skills - Proven leadership and team management experience - Ability to work effectively in a matrix organization - Proficiency in statistics, data analysis, interpretation and relevant software Additional Requirements -Bay Area preferable -Ability to travel if needed - Experience with electronic data capture systems - Knowledge of current industry trends and emerging technologies in clinical research - Track record of successful regulatory interactions
Negotiable
Redwood City
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Community Liaison (Marketing Representative)
Job Title: Community Liaison (Field Sales/Marketing Representative) Company: Top-tier rehabilitation center that offers a comprehensive program for patients recovering from brain injuries. Job Duties and Requirements: As a Community Liaison, you will be engaging with Occupational Medicine clinics, MD offices, and Worker's Compensation groups to foster recommendations and referrals within your designated region. The Community Liaison is expected to promote the organization's mission, core values, and ethics while maintaining professional relationships and consistently contributing to marketing goals. The role involves frequent travel, working in the community, at clinics, and from home. Strong communication, organizational skills, and attention to detail are essential for success in this position. Essential Duties: Referral Development: Schedule, conduct, and document outreach calls to various referral sources, including physicians, insurance companies, case managers, and patients. Demonstrate the organization's treatment approach to individuals with brain injuries. In-service Coordination: Identify and arrange opportunities for in-service training for referral sources. Represent the organization at local, regional, and national professional conferences, including trade shows. Handle marketing materials and set up display booths. Competitor Monitoring: Maintain up-to-date documentation on competitors, including pricing information. Travel: Travel within and outside the assigned region to achieve sales and marketing goals. Attend and participate in the National Marketing and Admission Meeting (or similar events). Database Management: Update and maintain marketing databases, including Salesforce, Concur, and ADP, as required by management. Ethical Conduct: Adhere to the organization's Ethics Policy and maintain professional relationships with staff, patients, and families. Required Skills and Qualifications: Education: A Bachelor's degree is preferred. Extensive experience in direct medical sales or referral development may offset the educational requirement. Experience: At least 2 years of experience in direct medical sales or referral development, ideally in the marketing of services. Experience in medical legal and workers' compensation in California is a plus. Knowledge: Familiarity with the medical continuum of care, including traumatic brain injury rehabilitation, workers' compensation, accident and health, and long-term disability insurance is preferred.
US$95000 - US$110000 per annum
Bakersfield
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Community Liaison (Field Sales/Marketing Representative)
Job Title: Community Liaison (Field Sales/Marketing Representative) Company: Top-tier rehabilitation center that offers a comprehensive program for patients recovering from brain injuries. Job Duties and Requirements: As a Community Liaison, you will be engaging with Occupational Medicine clinics, MD offices, and Worker's Compensation groups to foster recommendations and referrals within your designated region. The Community Liaison is expected to promote the organization's mission, core values, and ethics while maintaining professional relationships and consistently contributing to marketing goals. The role involves frequent travel, working in the community, at clinics, and from home. Strong communication, organizational skills, and attention to detail are essential for success in this position. Essential Duties: Referral Development: Schedule, conduct, and document outreach calls to various referral sources, including physicians, insurance companies, case managers, and patients. Demonstrate the organization's treatment approach to individuals with brain injuries. In-service Coordination: Identify and arrange opportunities for in-service training for referral sources. Represent the organization at local, regional, and national professional conferences, including trade shows. Handle marketing materials and set up display booths. Competitor Monitoring: Maintain up-to-date documentation on competitors, including pricing information. Travel: Travel within and outside the assigned region to achieve sales and marketing goals. Attend and participate in the National Marketing and Admission Meeting (or similar events). Database Management: Update and maintain marketing databases, including Salesforce, Concur, and ADP, as required by management. Ethical Conduct: Adhere to the organization's Ethics Policy and maintain professional relationships with staff, patients, and families. Required Skills and Qualifications: Education: A Bachelor's degree is preferred. Extensive experience in direct medical sales or referral development may offset the educational requirement. Experience: At least 2 years of experience in direct medical sales or referral development, ideally in the marketing of services. Experience in medical legal and workers' compensation in California is a plus. Knowledge: Familiarity with the medical continuum of care, including traumatic brain injury rehabilitation, workers' compensation, accident and health, and long-term disability insurance is preferred.
US$95000 - US$110000 per annum
Bakersfield
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