Manager, Clinical Quality Assurance
EPM Scientific Job In Philadelphia, PA Or Remote
This position is responsible for overseeing GCP/Clinical Quality Assurance activities with an industry leader in NASH/MASH Therapies. The main objective is to ensure the quality and compliance of clinical trials sponsored by a leading biopharmaceutical company focused on innovative therapeutics. This includes adherence to relevant GCP regulations, ICH GCP guidelines, company SOPs, and current industry standards and best practices. You will be partnering with the Sr. Director of Quality on this fully remote position.
Position Responsibilities:
Establish and maintain clinical quality systems and processes to ensure adherence to GCP, FDA, EMA, and other global regulatory requirements, fostering a culture of quality from the initiation of clinical trials to ensure patient safety and data integrity.
Collaborate across functions to apply a risk-based approach to compliance and participate in regular internal and external study team calls for ongoing quality oversight.
Partner with external vendors to ensure compliance is upheld and following up on internal Quality Event investigations, deviations, Observations/Findings, CAPAs, etc. to ensure closure.
Support and maintain the eQMS. Contributing to the annual audit plan and Quality Management Reviews.
Ensure clinical trial vendors operate in compliance with all applicable procedures, study documents, regulations/guidelines through Qualification audits and oversight activities, and manage internal/external audits (vendor, site, document, system or process) and prepare or review audit reports.
Review key documents such as IBs, Protocols/Amendments, Consents, TMF Plans, and support inspection readiness activities or provide assistance during global agency inspections.
Perform additional tasks in support of GCP Quality activities, and stay updated on applicable global regulations, guidance's, and industry best practices.
Qualifications and Skills Required:
5+ years of experience in Clinical QA within the biopharmaceutical or CRO industry, with extensive GCP knowledge; GLP/Nonclinical/GVP experience would be a plus.
Strong understanding of the cross-functional drug development process, including clinical trial functional operations, data management, statistics, etc., and ability to develop collaborative internal and external relationships.
Business and operational acumen, including the ability to escalate issues to management, and interact with all levels within an organization.
Experience in inspection preparation or supporting regulatory agency inspections, and eQMS systems
BS in life sciences or relevant field.
SVP, Account Services
EPM Scientific Job In Virgin, UT Or Remote
**Job Title:** Senior Vice President (SVP), Account Services
**Department:** Medical Communications - Publications and Medical Affairs
A leading medical communications and healthcare marketing company dedicated to synchronizing scientific excellence with strategic and creative vision. They specialize in strategic planning, publication planning and support, and medical communications, delivering extraordinary results for their clients.
**Position Overview:**
Seeking an experienced and strategic Senior Vice President (SVP) to lead Account Services team within the Medical Communications department, focusing on publications and medical affairs. The SVP will play a critical role in driving client success, managing high-level client relationships, and leading a team of account professionals to deliver exceptional medical communications solutions.
**Key Responsibilities:**
- **Strategic Leadership:** Develop and implement strategic plans for client accounts, ensuring alignment with client objectives and industry standards.
- **Client Management:** Build and maintain strong relationships with key clients, acting as a trusted advisor and ensuring high levels of client satisfaction.
- **Team Leadership:** Lead, mentor, and develop a team of account managers and directors, fostering a collaborative and high-performance culture.
- **Project Oversight:** Oversee the planning, execution, and delivery of medical communications projects, including scientific publications, medical affairs initiatives, and strategic communications plans.
- **Business Development:** Identify and pursue new business opportunities, contributing to the growth and expansion of the medical communications team.
- **Quality Assurance:** Ensure the highest standards of quality and compliance in all deliverables, adhering to industry regulations and guidelines.
- **Financial Management:** Manage account budgets, monitor financial performance, and ensure profitability of client engagements.
- **Industry Engagement:** Stay current with industry trends, advancements, and best practices in medical communications and publications.
**Qualifications:**
- Advanced degree in Life Sciences, Medicine, Pharmacy, or a related field.
- Minimum of 10 years of experience in medical communications, with a focus on publications and medical affairs.
- Proven track record of managing high-level client relationships and leading large teams.
- Strong understanding of scientific and medical terminology.
- Excellent strategic thinking, communication, and interpersonal skills.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Proficiency in project management tools and software.
**Benefits:**
- Competitive salary and performance-based bonuses.
- Comprehensive health and wellness benefits.
- Opportunities for professional development and career growth.
- Collaborative and supportive team culture.
- Flexible remote work environment.
Desired Skills and Experience
**Job Title:** Senior Vice President (SVP), Account Services
**Department:** Medical Communications - Publications and Medical Affairs
**Location:** Remote
A leading medical communications and healthcare marketing company dedicated to synchronizing scientific excellence with strategic and creative vision. They specialize in strategic planning, publication planning and support, and medical communications, delivering extraordinary results for their clients.
**Position Overview:**
Seeking an experienced and strategic Senior Vice President (SVP) to lead Account Services team within the Medical Communications department, focusing on publications and medical affairs. The SVP will play a critical role in driving client success, managing high-level client relationships, and leading a team of account professionals to deliver exceptional medical communications solutions.
**Key Responsibilities:**
- **Strategic Leadership:** Develop and implement strategic plans for client accounts, ensuring alignment with client objectives and industry standards.
- **Client Management:** Build and maintain strong relationships with key clients, acting as a trusted advisor and ensuring high levels of client satisfaction.
- **Team Leadership:** Lead, mentor, and develop a team of account managers and directors, fostering a collaborative and high-performance culture.
- **Project Oversight:** Oversee the planning, execution, and delivery of medical communications projects, including scientific publications, medical affairs initiatives, and strategic communications plans.
- **Business Development:** Identify and pursue new business opportunities, contributing to the growth and expansion of the medical communications team.
- **Quality Assurance:** Ensure the highest standards of quality and compliance in all deliverables, adhering to industry regulations and guidelines.
- **Financial Management:** Manage account budgets, monitor financial performance, and ensure profitability of client engagements.
- **Industry Engagement:** Stay current with industry trends, advancements, and best practices in medical communications and publications.
**Qualifications:**
- Advanced degree in Life Sciences, Medicine, Pharmacy, or a related field.
- Minimum of 10 years of experience in medical communications, with a focus on publications and medical affairs.
- Proven track record of managing high-level client relationships and leading large teams.
- Strong understanding of scientific and medical terminology.
- Excellent strategic thinking, communication, and interpersonal skills.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Proficiency in project management tools and software.
**Benefits:**
- Competitive salary and performance-based bonuses.
- Comprehensive health and wellness benefits.
- Opportunities for professional development and career growth.
- Collaborative and supportive team culture.
- Flexible remote work environment.
Oncology Sales Specilaist
EPM Scientific Job In Sacramento, CA
Role: Oncology Account Manager (solid tumor)
Company Type: Mid-Size Pharma
Territory: Sacramento / Central Valley
Company Profile
This Mid-Size Pharma is focused within oncology and looking to become a leading player in this space as a result; a highly experienced profile is required, with a strong Oncology and Specialty Sales background.
Summary
The Sales Professional will lead and own relationships with the Oncology portfolio by targeting appropriate influencers within the regional environment. They will build the expansion and integration for market position calling on key decision makers across the account territory and coordinate all appropriate selling activities for the Oncology portfolio.
Responsibilities
Engage and manage long-term relationships with Oncologists, physicians, nurses, office practices managers and other key stakeholders in the assigned territory
Strategy development to optimize product position and performance
Develop account plans for oncology accounts with specific tactics to drive sales performance within the account and achieve access for Oncology products on system protocols
Execute account plans and sales pull-through with local field teams
Responsible for meeting or exceeding assigned sales goals, brand key performance indicators and management by objectives
Desired Skill sets
3-5 years oncology sales experience within territory
Call point experience: hospital, academic, and community oncology selling
Solid tumor or Hem/Onc
Strong track record of success
If this sounds like you apply today!
Director, Trial Master File (TMF) Operations
EPM Scientific Job In San Francisco, CA
Job Type: Full-time
Salary: $200K-$215K
Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.
The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.
Responsibilities:
Leading the TMF Operations function to support Clinical Research and Development
Managing and overseeing the TMF Operations team, including hiring, training, and performance management
Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders
An ideal candidate for this role MUST have…
Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
Proven leadership experience in an insourced biotech organization
Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms
Benefits:
Pre-IPO biotech company
Competitive salary with comprehensive benefits (100% medical coverage)
401K contribution
Director, Trial Master File (TMF) Operations
EPM Scientific Job In Santa Rosa, CA
Job Type: Full-time
Salary: $200K-$215K
Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.
The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.
Responsibilities:
Leading the TMF Operations function to support Clinical Research and Development
Managing and overseeing the TMF Operations team, including hiring, training, and performance management
Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders
An ideal candidate for this role MUST have…
Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
Proven leadership experience in an insourced biotech organization
Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms
Benefits:
Pre-IPO biotech company
Competitive salary with comprehensive benefits (100% medical coverage)
401K contribution
Senior Manager, Global Market Research
EPM Scientific Job In Alameda, CA
Responsibilities:
Develop global market research plan and budget, ensuring compliance and quality control
Lead and build high-performance team, including Market Research Manager, Project Manager, and Analysts
Provide market data, analysis, and insights to support planning and business development
Manage vendor relationships and coordinate cross-functional collaboration for timely, accurate project outcomes
Requirements: MUST HAVE
Bachelor's degree
10+ years of experience in market research, commercial analytics, or primary market research within the pharmaceutical, biotech, or medical device industry (or consulting in these sectors) required
5+ years of management experience required
Expertise in secondary data analytics, forecasting, data visualization, and quantitative research methods
Global experience with the ability to work across different time zones
Applicants without the above qualifications will not be considered for this opportunity.
Senior Computational Scientist (AI/ML)
EPM Scientific Job In San Jose, CA
Title:
Senior Computational Scientist (AI/ML)
Salary:
$150,000-$345,000
EPM Scientific is currently partnered with an innovative biotech company that has developed a state-of-the-art AI/ML-driven drug discovery platform and continues to attract top talent from across the globe. With two late-stage clinical assets and strong financial backing, this company is well-positioned to advance R&D and cutting-edge technology development.
Role Overview:
We are seeking a highly motivated AI/ML Scientist to join our world-class research team and contribute to the next generation of computational drug discovery and protein engineering. In this role, you will apply advanced AI/ML techniques, including large language models, diffusion models, geometric deep learning, and computational protein design, to accelerate drug development and unlock new therapeutic possibilities.
Key Responsibilities:
Develop and apply machine learning models to solve complex challenges in computational biology, protein structure prediction, and drug discovery.
Design, train, and optimize deep learning algorithms using PyTorch and other modern frameworks.
Collaborate with interdisciplinary teams across AI, computational chemistry, and structural biology to integrate ML into drug discovery pipelines.
Publish high-impact research in leading ML and computational biology conferences/journals (ICML, NeurIPS, ICLR, etc.).
Stay ahead of cutting-edge advancements in AI/ML for biotech and contribute to the company's AI-first research strategy.
Minimum Qualifications:
PhD in Computer Science, Physics, Electrical/Computer Engineering, Bioinformatics, Computational Biology, or related fields.
Strong research background with publications in top AI/ML conferences (ICML, NeurIPS, ICLR) or computational biology journals.
Expertise in deep learning frameworks (PyTorch, TensorFlow, JAX) and programming in Python.
Experience in one or more relevant areas:
Large language models (LLMs) for molecular design.
Diffusion models for molecular generation.
Geometric deep learning for protein structure and conformation prediction.
Natural language processing (NLP) for bioinformatics applications.
Computational protein design and structure prediction.
Ability to work collaboratively in a fast-paced, interdisciplinary research environment.
Preferred Qualifications:
Experience in drug discovery, molecular docking, or cheminformatics.
Familiarity with biophysics, structural biology, or computational chemistry.
Strong track record of contributions to open-source AI/ML research or applied biotech projects
Stem Cell Scientist
EPM Scientific Job In San Francisco, CA
Title:
Scientist
Salary:
$100,000-140,000
A growing biotech company developing transformative solutions in cellular biology is seeking a Scientist with deep expertise in human pluripotent stem cell (hPSC) culture and directed differentiation. This full-time role focuses on the development and optimization of protocols to guide human iPSCs toward specific somatic lineages, with an emphasis on reproductive or endocrine cell types.
You'll join a collaborative research team working on innovative technologies with potential clinical applications, contributing to a platform that intersects reproductive biology, regenerative medicine, and advanced cell engineering.
Key Responsibilities:
Design and execute cell differentiation workflows using human pluripotent stem cells (hi PSCs)
Refine and optimize cell culture protocols to improve efficiency, reproducibility, and yield
Identify and troubleshoot technical challenges across various stages of differentiation
Maintain consistent cell quality and documentation across multiple experimental lines
Collaborate with cross-functional scientists to integrate new methods and improve experimental outcomes
Desired Qualifications:
Minimum of 2 years of hands-on experience with pluripotent stem cell (PSC) maintenance and directed differentiation
Proven ability to independently troubleshoot and refine complex cell culture protocols (must have)
Exposure to advanced techniques such as flow cytometry, genome editing, or high-throughput transcriptomic assays
Ideal Candidate Will Be:
Scientifically curious, detail-oriented, and capable of driving experiments independently
Comfortable working in a fast-paced, interdisciplinary environment
A collaborative communicator who brings fresh ideas and is eager to contribute to a mission-driven research effort
Open to learning new techniques and tackling technical challenges head-on
Note: Prior experience in reproductive biology is not required. Scientists from a broad range of cellular or developmental biology backgrounds are encouraged to apply. This is a unique opportunity to contribute to a groundbreaking research platform with long-term therapeutic potential.
Sr. Quality Systems Engineer
EPM Scientific Job In San Diego, CA
Company: Leading Pharmaceutical/Medical Device Company Sr. Quality Systems Engineer About the Company: Join a dynamic and innovative company that has developed a cutting-edge medical device and two groundbreaking drugs, including a "non-opioid" pain manager. With over 700 employees and $700M in revenue last year, this is an exciting time to become part of their growing team.
Key Responsibilities:
Ensure the quality and compliance of products and processes.
Administer and manage Master Control systems.
Collaborate with cross-functional teams to maintain and improve quality systems.
Why Join Us?
Be part of a leading company in the pharmaceutical and medical device industry.
Work on innovative products that make a difference in people's lives.
Collaborate with a talented and dedicated team.
Interested?
Please attach your resume and provide your best contact number. Let's discuss this exciting opportunity further! Reach out to ***************************** for further questions.
Desired Skills and Experience
Strategic Brand Marketing Manager
EPM Scientific Job In San Francisco, CA
Strategic Brand Marketing Manager - Pharmaceuticals
Located in the vibrant city of San Francisco, California, we are seeking an experienced Strategic Brand Marketing Manager to join our dynamic pharmaceuticals company. This position plays a crucial role in shaping our brand strategy and ensuring cohesive cross-collaborative efforts among Sales, Medical Affairs, and Commercial teams.
Key Responsibilities:
Develop and execute innovative marketing strategies tailored to the life sciences sector.
Collaborate effectively with Sales, Medical Affairs, and Commercial teams to align on brand vision and goals.
Leverage market insights to drive brand growth and market share.
Conduct market research and competitive intelligence to assess the evolving landscape and identify opportunities for growth.
Analyze key metrics to refine marketing strategies, monitor brand performance, and adapt tactics to improve results.
Assist in the execution of marketing programs and activities to support the brand's presence in the market.
Required Skills:
EPM: Utilize Enterprise Project Management skills to oversee major brand projects from conception through execution.
Brand Management: Demonstrated experience in managing brands within the pharmaceuticals sector, ensuring alignment with corporate objectives.
Strategic Thinking: Ability to think critically and strategically about long-term brand positioning and day-to-day operational challenges.
Experience in cross-functional collaboration, with the ability to influence stakeholders and drive brand objectives.
A Bachelor's degree in Marketing, Business, or a related field is required; an MBA or advanced degree is preferred.
Position Details:
This is a permanent role offering a competitive salary range of $130,000-$150,000k base plus bonus. The position requires three days per week on-site presence in San Francisco.
Candidate Profile
Ideal candidates will have at least 3 years of relevant experience in life sciences brand marketing. Strong analytical skills and a proven track record in strategic planning and cross-functional collaboration are essential.
Clinical Research Associate (Sr.)
EPM Scientific Job In San Francisco, CA
*** MUST BE LOCAL TO CA OR NY STATE - NO EXCEPTIONS ***
Salary: $100K-$125K
Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Research Associate for a hybrid role at their San Francisco site. Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, so they are looking for a driven, growth-oriented Clinical Research Associate to facilitate their in house studies.
The CRA will be responsible for:
Managing and investigating clinical trials and/or post-authorization safety studies
Performing and coordinating different aspects of clinical monitoring and site management
20-25% travel (1x a month)
An ideal candidate for this role MUST have…
2+ years of ONSITE monitoring experience at a sponsor or CRO (academia does NOT count)
A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline
A working knowledge of ICH GCP guidelines
Benefits:
Competitive salary with benefits
High degree of commercial exposure early in your career
Being a part of team whose work directly aims to improve the quality of people's lives
Great work-life balance
If you are interested in this Clinical Research Associate role, don't hesitate to reach out!
Director of Clinical Operations
EPM Scientific Job In San Francisco, CA
Director Clinical Operations
San Francisco, CA - Hybrid
$210,000- $240,000
We are partnered with an innovative Biotechnology company that is looking for their next Director of Clinical Operations. They have a robust pipeline of early to mid-phase trials and are in need of expanding their team. Although a newer company on the scene they have strong leadership who have gotten other products approved previously. This is a great opportunity to join a cutting-edge company with high potential at the ground floor.
Responsibilities
Oversee program management, including risk identification and mitigation, patient enrollment, quality oversight, and study completion.
Coach and mentor both direct and indirect reports, as well as recruit, hire, and develop new clinical operations team members.
Evaluate and manage Contract Research Organizations (CROs) and other service providers, serving as the primary point of contact.
Oversee the selection, contracting, and budget management for vendors and clinical trial sites.
Provide strategic, tactical, and operational input to cross-functional teams.
Manage all budgetary activities for assigned programs, including project budget creation, forecasting, accruals reporting, and invoice approval.
Plan and implement quality checks for multiple clinical trials.
Develop and support the creation of work instructions and Standard Operating Procedures (SOPs).
Qualifications:
Minimum of a BA/BS in a scientific or health-related field.
At least 8 years of experience in Oncology/Autoimmune/Aeurology clinical operations within the pharmaceutical or biotech industry.
Strong knowledge of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
Excellent leadership, organizational, and communication skills.
Proficiency in using Microsoft Office applications.
Associate Director, Clinical Scientist
EPM Scientific Job In San Francisco, CA
Job Type: Full-time
Salary: $195K - $205K
Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.
The Opportunity: The AD, Clin Ops will play a critical role in designing and implementing clinical trial protocols. Reporting to the Director, Clinical Science, this person will be responsible for serving as the lea clinical scientist and leading their medical monitoring team in review of clinical data.
Responsibilities:
Driving scientific execution of clinical protocol by serving as the lead clinical scientist or leading medical monitor team
Collaborating cross functionally to monitor clinical data to ensure trial quality and completeness
Ensuring CRF design supports data collection in alignment with protocol
Applying proficient analytical knowledge and skills to drive program objectives and mitigate risks
Assisting with generation and presentation of clinical data
An ideal candidate for this role MUST have…
10+ years of experience with a Bachelor's degree and 8+ years of experience with a post graduate degree (PhD/PharmD/MD/RN preferred)
3+ years of experience within oncology clinical development
Oncology experience is a MUST
Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents
A working knowledge of ICH GCP guidelines
Benefits:
Pre-IPO biotech company
Competitive salary with comprehensive benefits (100% medical coverage)
401K contribution
Director, Trial Master File (TMF) Operations
EPM Scientific Job In Fremont, CA
Job Type: Full-time
Salary: $200K-$215K
Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.
The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.
Responsibilities:
Leading the TMF Operations function to support Clinical Research and Development
Managing and overseeing the TMF Operations team, including hiring, training, and performance management
Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders
An ideal candidate for this role MUST have…
Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
Proven leadership experience in an insourced biotech organization
Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms
Benefits:
Pre-IPO biotech company
Competitive salary with comprehensive benefits (100% medical coverage)
401K contribution
Director, Trial Master File (TMF) Operations
EPM Scientific Job In Hayward, CA
Job Type: Full-time
Salary: $200K-$215K
Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.
The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.
Responsibilities:
Leading the TMF Operations function to support Clinical Research and Development
Managing and overseeing the TMF Operations team, including hiring, training, and performance management
Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders
An ideal candidate for this role MUST have…
Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
Proven leadership experience in an insourced biotech organization
Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms
Benefits:
Pre-IPO biotech company
Competitive salary with comprehensive benefits (100% medical coverage)
401K contribution
Product Manager
EPM Scientific Job In San Diego, CA
We are excited to announce a career opportunity for a Product Manager in the dynamic sector of Commercial Life Sciences located in Greater San Diego. This permanent position is pivotal in shaping product strategy and education, ensuring our clients products not only meet market needs but also exceed expectations. The ideal candidate will play a crucial role in driving the commercial success of our clients products, leveraging their expertise to align product development with consumer demands and technological advancements.
Key Responsibilities:
Develop tactical and strategic product plans that effectively address market demands and future trends.
Conduct training sessions for team members and dealers on product features and benefits, equipping them with the knowledge and skills needed to maximize sales performance.
Maintain accuracy in pricing and content distribution across various channels, ensuring consistency and compliance with market standards.
Skills Required:
Biologics Background
Experience in direct client interactions and sales presentations to drive revenue growth, with a proven track record of achieving sales targets.
Understanding of sales processes and market strategies specific to high-value equipment in life sciences, ensuring effective market penetration and competitive positioning.
This role is ideal for someone passionate about making a significant impact in the field of life sciences through innovative product management and effective team leadership. We are looking for a driven, analytical, and resourceful individual who thrives in fast-paced environments and is committed to long-term business success.
Clinical Trial Coordinator (m/w/d)
EPM Scientific Job In San Mateo, CA
We have a current opportunity for a Clinical Trial Coordinator (m/w/d) on a contract basis. The position will be based in South San Francisco. This is a hybrid position with 3 days on site required (Tuesday - Thursday). This is a 1.0 FTE role, meaning 40 hours per week, for an initial 9 month contract.
Desired Skills and Experience
2+ years experience as a Clinical Trial Assistant/Coordinator or equivalent
Experience in oncology studies preferred
Experience in Pharma/Biotech/CRO a plus
Relevant scientific degree is desired, but not essential
Language skills in Korean, Chinese or Japanese are highly desired
Associate Director, HCP Marketing
EPM Scientific Job In San Francisco, CA
San Francisco, CA (Hybrid; must be on-site 3x a week)
I am partnered with a mid-sized biotech company dedicated to providing patients who suffer from chronic pain with non-opioid treatment options. This role will be responsible for developing and executing HCP marketing strategy, ensuring alignment with organizational goals. The company is seeking a creative marketer to refine HCP engagement and long-term positioning tactics.
Responsibilities:
Develop and execute HCP marketing strategies to increase brand awareness.
Lead the development of HCP-targeted materials, ensuring consistent messaging across all channels.
Collaborate cross-functionally with Sales, Medical Affairs, Insights & Analytics, and Regulatory teams to ensure alignment on brand strategy.
Conduct market research to understand HCP needs and the competitive landscape.
Continuously analyze campaign performance and adjust tactics to optimize results.
Build relationships with HCPs and KOLs, and develop programs to engage them.
Represent and promote the brand at HCP-focused conferences.
Qualifications:
5-8 years of marketing experience.
Pharmaceutical or Biotech marketing experience required.
Bachelor's degree required; advanced degree preferred.
Director, Trial Master File (TMF) Operations
EPM Scientific Job In Sonoma, CA
Job Type: Full-time
Salary: $200K-$215K
Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.
The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.
Responsibilities:
Leading the TMF Operations function to support Clinical Research and Development
Managing and overseeing the TMF Operations team, including hiring, training, and performance management
Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders
An ideal candidate for this role MUST have…
Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
Proven leadership experience in an insourced biotech organization
Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms
Benefits:
Pre-IPO biotech company
Competitive salary with comprehensive benefits (100% medical coverage)
401K contribution
Director, Trial Master File (TMF) Operations
EPM Scientific Job In Sunnyvale, CA
Job Type: Full-time
Salary: $200K-$215K
Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.
The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.
Responsibilities:
Leading the TMF Operations function to support Clinical Research and Development
Managing and overseeing the TMF Operations team, including hiring, training, and performance management
Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders
An ideal candidate for this role MUST have…
Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
Proven leadership experience in an insourced biotech organization
Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms
Benefits:
Pre-IPO biotech company
Competitive salary with comprehensive benefits (100% medical coverage)
401K contribution