About the role: 

Superluminal Medicines, Inc. is seeking a highly organized, detail oriented, and experienced Compound Manager to help us build and execute a fully integrated, automated, and data-driven compound management. This role is essential to ensure that the scientists can focus on the science and trust that every experimental data point that is collected is underpinned by confidence in the compounds being tested. The person that fills this role understands how fundamental and critical compound management is to the experimental data being generated and how important data capture, recording, and communication is to drug discovery. 

Superluminal’s platform aims to develop candidate-ready compounds with unprecedented speed using a combination of deep biology, computational and medicinal chemistry, machine learning, and proprietary big data infrastructure. The ideal candidate is highly motivated, thrives in a startup environment, and brings strong experience in compound management.

Key responsibilities: 

• Key business partner to chemistry and biology
• Monitor Smartsheets for weekly orders then coordinate orders of weekly shipments from external compound management CROs. Regularly communicate with the chemistry and biology team around order progress and any hurdles encountered.
• Update Smartsheets with compound and mother plate inventories. Monitor inventories and flag compounds for resynthesis as needed.
• Manage and track shipments between CROs and Superluminal.
• Execute internal compound management capabilities:
• Maintain internal inventory
• Receive and evaluate plates for potential issues, flagging to chemistry and biology as appropriate
• Create assay ready plates using in house automation
• Create cherry pick plates from mother plates for follow-up
• Generate QC plates and prepare for shipment or internal analysis
• Develop, document, and maintain SOPs
• Ensure compliance with all laboratory safety requirements including OSHA, biosafety, chemical hygiene and other regulatory standards
• Identify inefficiencies in our operational processes and implement solutions to address them

Qualifications & Skills:                                                                                                                                                                                                                                                                 

• Bachelor’s degree in Biology, Chemistry, or closely related field
• 5+ years of industry experience in compound management
• Experience coordinating efforts with external CROs
• Experience with laboratory automation
• Experience with Smartsheets or other tracking systems a plus
• Strong attention to detail
• Highly organized self-starter with a strong ability for problem solving and effective execution
• Strong communication skills and ability to work effectively across multiple tasks
• Ability to work onsite full-time

About Avalyn

Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA-IPF, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.

Position Overview

The Associate Director of SEC Reporting & Technical Accounting will build and lead Avalyn’s external reporting and SOX compliance capabilities as a newly public biotechnology company. This high-impact, foundational position is ideal for a technically strong, pragmatic leader who enjoys creating structure in a dynamic, mission-driven environment. The Director will establish scalable SEC reporting processes, design and document internal controls over financial reporting, and serve as the Company’s subject matter expert on complex accounting matters. Reporting to the VP of Finance, this role partners closely with Finance and cross-functional teams across the organization to drive alignment, accountability, and best practices through strong collaboration and clear communication.

SEC Reporting

• Lead the preparation and timely filing of SEC reports, including Forms 10-K, 10-Q, 8-K, and S-8, and oversee XBRL tagging and related external reporting processes.
• Own the preparation and review of financial statements, footnotes, and MD&A, ensuring compliance with U.S. GAAP and SEC regulations.
• Partner with Legal, FP&A, Investor Relations, and senior leadership on earnings releases, proxy materials, and other public disclosures.

Technical Accounting

• Serve as the company’s subject matter expert on technical accounting matters, including revenue recognition, collaboration and licensing arrangements, R&D activities, financing transactions, and stock-based compensation under ASC 718.
• Research, evaluate, and document accounting conclusions for complex transactions and prepare technical accounting memoranda and policy documentation.
• Support commercialization readiness by helping establish GAAP- and SOX-compliant revenue accounting and order-to-cash processes in partnership with Commercial, Market Access, Finance, and IT.

SOX Compliance & Internal Controls

• Design and implement internal controls over financial reporting as the company continues to build toward full SOX compliance.
• Lead walkthroughs, risk assessments, control documentation, and remediation efforts in partnership with process owners and external consultants.
• Strengthen scalable controls and operating processes across SEC reporting, technical accounting, and equity administration.

Equity Accounting & Administration

• Lead equity accounting, including the calculation and recording of stock-based compensation in accordance with ASC 718.
• Oversee external support for day-to-day stock administration activities and help ensure strong governance around equity-related processes.
• Support Section 16 reporting and related compliance requirements in coordination with legal counsel.

External Audits

• Manage quarterly reviews and annual audits and serve as the primary liaison with external auditors on technical accounting matters.
• Coordinate PBC requests and support an efficient, well-organized audit process.

Qualifications

• A minimum of a Bachelor’s degree in Accounting or Finance required; CPA required.
• 8-10+ years of progressive accounting experience, including substantial SEC reporting and technical accounting experience in a public company environment.
• Big 4 or national public accounting firm experience strongly preferred.
• Demonstrated experience building or enhancing SOX compliance programs.
• Experience in biotechnology, life sciences, or other R&D-intensive industries strongly preferred; experience with cell therapy revenue recognition is a plus.
• Deep knowledge of U.S. GAAP and SEC regulations, including revenue recognition, equity compensation, and complex transaction accounting.
• Experience with tools such as Active Disclosure, Equity Edge, NetSuite, or similar systems preferred.
• Strong communication, sound judgment, and the ability to lead through influence in a fast-paced, mission-driven environment.

Legend Biotech is seeking a Cell Therapy Account Specialist, Overlay (Contractor) as part of the Commercial team based in (Boston North, MA, Boston South, MA).

Role Overview

The Cell Therapy Account Specialist is responsible for representing Legend’s products and services to a defined customer base, generating and growing sales and consistently achieving or exceeding sales targets within a specific geographic area.

Key Responsibilities

• Work in partnership to drive Carvykti as the preferred CAR-T therapy for multiple myeloma among both community and institution-based oncology customers. This role involves collaborating with other Carvykti representatives to coordinate activities for impactful engagement within the territory.
• Comprehensive understanding of Legend and competitor products in our therapeutic area, and an in-depth knowledge of the complexities associated with the disease state.
• Ability to navigate a complex account environment and understand the needs/issues of various stakeholders at all levels within the account and triage to appropriate internal stakeholders for support.
• Develops an understanding of the issues and opportunities unique to each geography.
• Provides all insights to the cross functional team on appropriate and timely feedback from interactions with healthcare professionals (HCPs), including account business trends and potential changes in therapeutic landscape.
• Leverages intel and insights to develop and assertively implements an account business plan to meet customer needs and achieve corporate goals.
• Works cooperatively with internal team members on various cross-functional projects related to specific accounts or physicians. May work in collaboration with outside partner companies to co-promote products or services.
• Assists in the identification/resolution of issues and opportunities and communicates proactively to marketing and sales management. Manages a territory budget plan for customer engagements, speaker events and other miscellaneous external expenditures.
• Represents Legend at National and/or local symposiums/conventions.
• Demonstrates initiative and willingness to work hands-on with a sense of urgency, in a fast-paced entrepreneurial environment.
• Demonstrates leadership among peers by consistent application and modeling of appropriate, compliant behavior, and conduct.
• Performs all administrative functions required for the position, including reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc.
• Reports adverse events to Legend’s Drug Safety department and other internal departments as appropriate per required guidelines.
• Actively promotes the appropriate use of Legend’s products to healthcare professionals in accordance with Corporate, PhRMA, and OIG guidelines.
• Strict compliance with all regulatory agencies, state, and federal law is required.
• Adheres to company policies, procedures, and business ethics.

Requirements

• Bachelor’s Degree from accredited college or university.
• Preferred 3 years of Oncology, specialty healthcare sales experience.
• Proven and consistent track record of meeting/exceeding sales objectives, preferably in specialty markets.
• Experienced managing and executing within large community accounts including strategic planning and problem solving.
• Previous sales experience in cell therapy/bone marrow transplant is a plus.
• Previous product launch experience in a highly competitive environment.
• Exceptional interpersonal, communication (written and presentation) skills.
• Possess superior selling skills honed in highly competitive markets.
• Proven expertise in building relationships and influencing.
• Aptitude for rapid learning and retention of technical and scientific product related information.
• Must set high goals and standard of performance and be self-motivated and able to work with a general level of autonomy.
• Demonstrated team work/collaboration.
• Demonstrated ability to read situations quickly, anticipate and adjust for problems and roadblocks.
• Valid driver’s license.
• Agility in multi-tasking.
• Able to travel up to 50-60% of the time.
• Proven track record of attaining organizational objectives.
• Exceptional organizational and time management skills.
• Ability to perform administrative responsibilities accurately and on time.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).

#Li-JK1

#Li-Remote

Location: Galena, KS

Position Summary
The Laboratory Technician supports Manufacturing, Quality, Formulation operations by performing routine laboratory testing, material inspections, documentation, and data analysis. This role helps ensure product quality, regulatory compliance, and adherence to established safety and quality system requirements. 

Compensation & Benefits 

• Employee Ownership (ESOP): Company-funded retirement contribution of ~18% of pay, plus 401(k) 
• Competitive pay with bonus opportunity 
• Comprehensive benefits: Medical, Dental, Vision, Life, Disability, FSA, and Pet Insurance 
• Generous paid time off, paid holidays, and parental leave 
• Fitness reimbursement and tuition assistance 

Essential Duties & Responsibilities

• Perform routine physical and analytical testing of raw materials, in-process samples and finished product, including particle size distribution, pH, emulsion stability, specific gravity in accordance with approved SOPs and test methods.
• Collect, Record & Analyze Manufacturing/Lab/Quality data in graphical form.
• Monitor and approve line start-ups and clearances for both liquid and granular production in collaboration with manufacturing.
• Support formulation chemists in closure of Manufacturing batches in D365 & assist in D365 Inventory management.
• Catalog, label, retain, store, and retrieve samples in accordance with retention and storage procedures.
• Support in processing documentation for inbound/outbound loads for raw materials for Manufacturing/Quality Lab Processes.
• Monitor and assist with correcting all observed non-conformances during production.
• Follow all applicable SOPs, work instructions, safety procedures, and quality policies; promptly report nonconformances, deviations, or safety concerns to supervision.
• Maintain good housekeeping practices and comply with environmental, health, and safety (EHS) requirements, including proper use of personal protective equipment (PPE) 
• Perform other related duties assigned in support of laboratory, manufacturing, or quality operations. 

Required Qualifications

• High School Diploma with experience in related laboratory workplace; or Associates or BA/BS in a science degree.
• Basic proficiency in Microsoft Excel (data entry, basic formulas, charts). 
• Working knowledge of Microsoft Outlook, Word, and PowerPoint. 
• Competent basic math skills. 
• Ability to follow written procedures and instructions accurately. 
• Strong attention to detail and organizational skills. 
• Ability to work effectively in a team environment and communicate professionally. 
• Ability to complete assigned tasks with limited supervision when required. 
• Ability to lift to 50 pounds. 
• Ability to stand and walk for extended periods during the work shift. 
• Ability to climb ladders and stairs to perform inspections. label, retain, store, and retrieve samples in accordance with retention and storage procedures. 

Preferred Qualifications

• Previous laboratory, manufacturing, or quality experience preferred but not required. 

Work Environment & Culture 

We offer a collaborative, employee-owned workplace where accountability, teamwork, and continuous improvement matter. Employees are encouraged to share ideas, grow their skills, and build long-term careers. 

Equal Opportunity Employer 

We are an Equal Opportunity Employer and are committed to creating an inclusive workplace for all employees. 

Ready to Apply? 

If you enjoy dependable, hands-on work and want to be part of a team that values safety, teamwork, and ownership, we’d love to hear from you. 
Apply today. 

About Every Cure:   

Every Cure is an AI-driven nonprofit, biotech organization on a mission to save and improve lives by repurposing existing medicines for diseases with significant unmet need. We are working to create a world where every drug is used to treat every disease it possibly can, so that no patient suffers when an existing treatment could help them. We are filling a gap left by the current biomedical system, which doesn’t systematically pursue new uses for old drugs. Through artificial intelligence technologies, collaboration with healthcare professionals, and patient advocacy, Every Cure is dedicated to unlocking the full potential of existing medicines to treat every disease and every patient we possibly can. Inspired by Every Cure’s co-founders' work repurposing drugs for Castleman disease and other rare diseases, Every Cure is advancing repurposed treatments for neglected diseases and has been featured in The New Yorker,  New York Times, USA Today, Good Morning America and other news media. Led by a talented leadership team and an outstanding Board of Directors, Every Cure is supported through funding from leading philanthropic organizations like Chan Zuckerberg Initiative, TED’s Audacious Project, and ARPA-H. 

 Our approach:  

• AI-Powered Identification: We use advanced artificial intelligence to analyze the world’s biomedical knowledge and identify FDA-approved drugs that can be repurposed for untreated conditions. This cutting-edge technology enables us to explore new therapeutic possibilities efficiently.  
• Open-Source Commitment: We are dedicated to making our predictive pipeline open-source, fostering collaboration and transparency within the scientific community and unlocking the potential for discovering new treatments.  
• High-Impact Focus: We prioritize drug repurposing opportunities that will relieve the most suffering and have the greatest impact possible.  
• Rigorous Validation: Promising opportunities are thoroughly validated through laboratory and clinical studies to confirm their efficacy and safety before advancing to broader application.  
• Strategic Marketing and Access: We disseminate information about effective repurposed treatments through multiple channels and are committed to ensuring that new cures are accessible to all patients.

Applicants must reside in the state specified at the top of this job posting. Residency in that state is a requirement for consideration and must be maintained for the duration of employment.

The Head of Clinical Development leads Every Cure’s clinical research and development function, serving as both strategic architect and working clinical lead on priority programs. They manage a diverse portfolio of drug repurposing initiatives including Every Cure-sponsored interventional trials (with full sponsor IND accountability and REMS complexity where applicable), collaborative investigator-sponsored trials, and Every Cure-led patient registries, natural history studies, and other real-world studies. They collaborate directly with computational and data science teams to translate AI-driven repurposing hypotheses into clinically testable programs and represent the organization to external partners and stakeholders. This role owns sponsor compliance under ICH E6(R3) including maintenance of the clinical QMS and SOP infrastructure regardless of CRO engagement  and oversees regulatory strategy and dissemination. The HCD supports Every Cure’s CSO and engages directly with external stakeholders including CROs, clinical trial technology vendors, academic investigators, patient advocacy organizations, the IRB of record, and FDA. The HCD helps build and lead a lean internal clinical development team, modeling the working-leader norm expected in a small, mission-driven organization.

How you will make an impact: 

Strategic Leadership of Clinical Development and Medical Affairs

• Set the direction for Every Cure’s clinical research and development, ensuring alignment with the organization’s mission to repurpose FDA-approved drugs for high-impact unmet needs, while personally leading or co-leading priority programs.
• Lead the execution of organizational goals through operational planning and cross-functional integration, personally owning project timelines, quality standards, and accountability metrics for priority programs rather than delegating all execution.
• Provide expert counsel to the CSO, President and Scientific Advisory Council on medical strategy, program development, and organizational growth.

Research and Clinical Development Oversight

• Design, author, and review key study documents (protocols, statistical analysis plans, informed consent documents, clinical study reports, investigator brochures) for Every Cure-sponsored clinical trials, patient registries, natural history studies, and real-world evidence assessments. Own study design decisions end-to-end, from scientific rationale through data integrity and analysis.
• Serve as sponsor medical lead and/or medical monitor on Every Cure-sponsored IND-holding studies (delegating per-study where appropriate), ensuring all research activities are ethically sound, methodologically rigorous, and regulatory compliant under FDA 21 CFR Part 312, ICH E6(R3), and ICH E9 principles.
• Translate complex medical findings into strategic decisions regarding program continuation, optimization, or sunsetting, based on efficacy, feasibility, and patient impact.
• Responsible for compliance and oversight of the Human Subjects Research program at Every Cure, including IRB (Advarra) submissions and amendments, sponsor safety reporting (IND safety reports, DSURs), SAE adjudication, signal detection, and REMS program participation where applicable (e.g., lenalidomide).

Portfolio Strategy and Program Management

• Partner on strategic prioritization and dynamic management of Every Cure’s diverse portfolio of drug repurposing opportunities, applying a risk-adjusted, impact-oriented lens to maximize outcomes.
• Direct the progression of programs through clinical and dissemination stages, using insights from AI models and external scientific inputs. Personally lead CRO and clinical technology vendor selection, contracting input, and ongoing governance (joint steering committees, KPIs, oversight plans) for highest-priority programs.
• Develop and manage resource allocation frameworks across disease areas and therapeutic modalities, ensuring optimal investment of time, talent, and funding toward the most promising interventions.

Leadership and Team Development

• Build, mentor, and lead a lean, high-performing team of clinical research and medical professionals united around a shared vision of maximizing patient impact through drug repurposing, modeling a working-leader norm in which senior leaders contribute directly alongside their teams.
• Define roles, responsibilities, and performance standards for the clinical team while fostering a culture of excellence, integrity, psychological safety, and cross-functional collaboration.
• Promote continuous learning and growth through coaching, training programs, and development opportunities that build both individual capability and team effectiveness.

Stakeholder Engagement, Compliance, and Dissemination

• Act as medical spokesperson and lead regulatory interface for Every Cure in public, scientific, and regulatory forums (including FDA pre-IND and Type B/C meetings), promoting the organization’s mission and sharing results from preclinical and clinical programs.
• Cultivate and manage partnerships with CROs, patient advocacy groups, academic institutions, and regulatory agencies to ensure successful execution and wide-scale impact of therapeutic programs.
• Guide the regulatory approval and post-study dissemination strategies to ensure timely and effective translation of research into therapies accessible to patients, including peer-reviewed publications, policy briefs, and healthcare provider outreach.
• Partner with the Impact lead to provide input and perspective on dissemination and to engage with key stakeholders to ensure medicines reach patients.

What you bring to the team:

Education 

• MD or MD/PhD preferred; PhD DO, or PharmD acceptable

Work Experience (Two-Tier: Head of / VP)

• Minimum for Head of Clinical Development: 8+ years of clinical development experience post-MD (or equivalent), including service as clinical lead on at least one sponsor-held Phase 2 trial from protocol through database lock.
• Demonstrated leadership experience recruiting, mentoring, and managing cross-functional clinical teams, with explicit willingness and proven ability to work hands-on alongside direct reports in a small-organization setting.
• Expertise in drug development, clinical trial design (including interventional trials in rare or ultra-rare populations), and clinical decision-making.
• Sponsor-side experience running Phase 2 trials (distinct from CRO or academic investigator experience).
• Experience working across more than one therapeutic research area.
• Experience with small-sample trial designs and natural history or registry data.
• Proven leadership in driving strategic initiatives and cross-functional collaboration to advance scientific and organizational goals.

Preferred for Vice President designation:

• 12+ years of clinical development experience, including prior functional leadership at a sponsor (Executive Director, Head of, or VP level); multiple sponsor-held INDs led through Phase 2 or beyond; direct experience with REMS programs, risk-based monitoring, or similarly complex regulatory programs; and prior responsibility for building or scaling a clinical QMS under ICH E6(R3) or predecessor standards.

Skills 

• Proficiency in clinical research, real-world evidence assessments, evidence generation, patient registry design, clinical trial execution, and sponsor-side pharmacovigilance.
• Working knowledge of FDA IND regulations (21 CFR Part 312), ICH E6(R3) Good Clinical Practice, ICH E9 statistical principles, 21 CFR Part 11 for electronic records, and REMS program requirements; familiarity with EU CTR a plus.
• Exceptional communication and presentation abilities.
• Demonstrated ability to foster and sustain a collaborative, cross-functional culture grounded in shared organizational mission and values.
• Able to partner effectively with computational and data science teams and critically evaluate AI/ML-driven repurposing hypotheses for clinical translatability.
• Strategic thinker with a focus on urgency, efficiency, and impact.
• Passionate about Every Cure’s mission and values.
• Highly adaptable, thriving in a fast-paced, start-up environment.
• Explicit willingness to be hands-on: comfort authoring and reviewing key clinical documents (protocols, SOPs, CSRs), directly managing vendor/CRO relationships, and working alongside junior staff rather than exclusively through delegation. Candidates seeking a purely oversight or figurehead role are not a fit for this position.

Compensations & Benefits: 

• Your paycheck: Competitive salary based on experience, ranging from $250,000 - $275,000 annually. 
• Health and wellness: Comprehensive plans with medical, dental, and vision coverage, plus a Flexible Spending Account (FSA) for eligible healthcare expenses. 
• Future nest egg: A 403(b)-retirement plan with an employer match of 3.5% helps you save for your future. 
• Relax and recharge: Generous time off, including paid time off and paid holidays. 
• We have you covered: Comprehensive paid leave for family and medical needs, ensuring you have the support you need during important times. 

This role is based in Cambridge, MA, with an expectation of minimum 3 days per week in office.  

Every Cure is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, or any other characteristic protected by federal, state, or local laws.

Description of Role

Key Responsibilities

Strategic Leadership & Oversight 

• Develop and execute a comprehensive pharmacovigilance (PV) strategy aligned with corporate objectives and regulatory expectations.
• Lead safety governance and benefit-risk management for small molecule assets across development and post-marketing.
• Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA, etc.).
• Provide strategic safety input into clinical trial designs, protocols, and regulatory submissions.
• Establish and oversee PV partnerships, vendors, and external collaborations. 

Operational & Regulatory Compliance 

• Lead the safety surveillance and signal detection process, ensuring timely identification and mitigation of safety risks.
• Oversee the preparation and submission of safety reports (e.g., DSURs, PSURs, RMPs, SUSARs, IND safety reports, 15-day alerts).
• Ensure robust case processing, signal evaluation, and risk management processes are in place.
• Represent the company in regulatory interactions regarding safety matters (FDA, EMA, etc.). 

Cross-Functional Collaboration 

• Work closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to integrate safety considerations into decision-making. 
• Partner with Regulatory Affairs to support new drug applications (NDAs) and marketing authorizations.
• Support DSMBs, advisory boards, and investigator meetings with safety expertise. 

Team Leadership & Development 

• Build and lead a high-performing pharmacovigilance team, fostering a culture of scientific excellence and compliance.
• Provide mentorship and guidance to internal safety professionals. 

Compensation

The annual base salary range for this position is $350,000.00 to $380,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Vice President, Pharmacovigilance and Safety role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

Description of Role

We are seeking a Senior Scientist, Drug Safety (Pharmacovigilance) to support pharmacovigilance activities across Centessa’s clinical-stage development programs. Reporting to Centessa’s Head of Safety and Pharmacovigilance, this role will contribute to the review and analysis of safety data to support ongoing safety surveillance, regulatory compliance, and program execution. The Senior Scientist will work closely with cross-functional partners and external vendors to ensure high-quality safety deliverables and maintain inspection-ready pharmacovigilance processes in a fast-paced, development-focused environment. 

Key Responsibilities

• Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs. 
• Lead the development of high-quality case narratives and guide the scientific preparation of regulatory ready case submissions, including SUSARs, in alignment with global reporting requirements. 
• Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products. 
• Oversee literature surveillance to identify new or evolving safety information, interpret clinical relevance, and communicate findings to cross-functional stakeholders. 
• Ensure the scientific integrity and quality of safety data through expert review of complex cases and mentorship of junior team members in case assessment and safety data interpretation.  
• Provide senior level scientific input into the preparation and review of DSURs, line listings, safety summaries, and safety-related sections of protocols, Investigator’s Brochures, and regulatory submissions. 
• Serve as the lead drug safety representative on cross-functional study teams, shaping safety strategy, influencing program decision-making, and advising on safety issue management.
• Maintain expert level knowledge of therapeutic areas and global drug safety regulations, guidelines, and evolving best practices (e.g., FDA, EMA, ICH, CIOMS), and apply this expertise to program decisions and safety governance. 
• Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.  
• Lead or contribute to complex, cross-functional safety projects, safety signal evaluations, and ad-hoc scientific analyses to support portfolio needs and organizational priorities. 

Qualifications

•  PharmD or PhD in scientific field
• 6+ years of experience of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.  
• Prior experience facilitating in Safety Risk Assessment Meetings / Safety Review activities required. 
• Working knowledge of global PV regulations and guidelines applicable to clinical development (e.g., FDA, EMA, ICH, GCP).
• Experience with PV databases and safety surveillance tools (e.g., Argus, ArisGlobal, Vault Safety); familiarity with MedDRA coding preferred.
• Experience supporting clinical safety case processing and aggregate reporting.
• Strong analytical skills, attention to detail, and comfort working across multiple programs.
• Clear communicator who works effectively in small, cross-functional teams.
• CNS experience preferred. 

Compensation 

The annual base salary range for this job level is $145,000 to $190,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location 

Based in the US, with <10% travel.

POSITION: Full-Time, Exempt

Description of Role

Centessa is seeking an experienced Senior Director, Clinical Pharmacology to provide scientific and strategic leadership for clinical pharmacology across a diverse pipeline spanning early development through late-stage and registrational programs. Reporting to the Executive Director, Clinical Pharmacology, this position is accountable for developing and executing clinical pharmacology strategies that address the unique challenges of neuroscience drug development, including CNS exposure, dose optimization, and translational relevance. The Senior Director partners closely with cross-functional teams and represents clinical pharmacology in regulatory interactions to enable efficient, data-driven advancement of therapies across our neuroscience portfolio.

Key Responsibilities

• Lead clinical pharmacology strategy for CNS and neuroscience programs from first‑in‑human through registrational and post‑marketing stages 
• Design, execute, and interpret clinical pharmacology studies, including FIH, multiple‑ascending dose, DDI, biopharmaceutics, and patient studies 
• Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS‑specific biomarkers  
• Lead model‑informed drug development, including population PK, PK/PD, and exposure–response analyses relevant to CNS targets and clinical safety
• Assess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers  
• Serve as the clinical pharmacology lead on program teams, clinical sub‑teams, and trial working groups 
• Author and oversee clinical pharmacology sections of regulatory documents (e.g., INDs, CTAs, IBs, NDAs)  
• Represent clinical pharmacology in interactions with FDA and other global health authorities, supporting dose justification and labeling discussions  
• Partner closely with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs  
• Oversee CROs and external vendors conducting clinical pharmacology and modeling activities  
• Ensure timely communication and clear interpretation of clinical pharmacology results to internal stakeholders 
• Contribute to portfolio strategy, program prioritization, risk mitigation, and long‑range clinical development planning for CNS assets 
• Serve as a subject‑matter expert on clinical pharmacology 
• Mentor and develop clinical pharmacology talent as the pipeline and organization grow  
• Ensure high‑quality, submission‑ready documentation aligned with global regulatory standards 

Qualifications

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline 
• 8–12+ years of experience in clinical pharmacology within biopharma, with demonstrated impact in clinical drug development 
• Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support 
• Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessment 
• Demonstrated experience applying quantitative clinical pharmacology approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection and optimization  
• Proficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent 
• Experience authoring and delivering clinical pharmacology components of regulatory submissions (e.g., INDs, CTAs, NDAs) and interacting with global health authorities  
• Strong understanding of translational PK, CNS exposure considerations, and biomarker integration in neuroscience drug development  
• Excellent communication, collaboration, and leadership skills with the ability to operate effectively in a fast‑paced, matrixed environment 

Compensation 

The annual base salary range for this position is $270,000.00 to $295,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location

The Senior Director, Clinical Pharmacology role is a remote role based in the US, with occasional travel. 

POSITION: Full-Time, Exempt

Description of Role

Centessa is seeking a (Senior) Clinical Trial Manager (CTM) to lead the execution of mid‑ to late‑stage global clinical studies from study start‑up through close‑out and clinical study report. The (Sr) CTM is responsible for day‑to‑day trial management, coordinating internal cross‑functional teams and overseeing CROs and external vendors to ensure studies are delivered on time, within budget, and in compliance with quality and regulatory standards. This role requires hands‑on involvement in clinical trial execution, proactive identification and resolution of operational issues, and accountability for study performance metrics and deliverable quality. The (Sr) CTM also contributes to operational planning, risk assessment, and continuous process improvement in collaboration with study team leadership.

Key Responsibilities

• Plan and execute mid‑ to late‑stage CNS clinical trials from study start‑up through close‑out, ensuring operational excellence, high data quality, and compliance with protocol, GCP, and global regulatory requirements.
• Lead day‑to‑day clinical trial operations, coordinating cross‑functional partners (Clinical Development, Data Management, Biostatistics, Regulatory, Safety) to ensure efficient trial execution and alignment to program objectives.
• Oversee CROs and external vendors supporting CNS clinical trials, including co‑monitoring activities, to ensure delivery against scope of work, timelines, budget, and quality expectations.
• Drive critical study milestones, including site activation, enrollment progress, patient retention, data cleaning, and database lock, proactively addressing operational challenges common to CNS trials.
• Review and approve CRO‑ and vendor‑generated plans and study documentation, ensuring alignment with protocol, regulatory expectations, and Centessa quality standards.
• Monitor study progress and performance using operational metrics and tools, maintaining dashboards, timelines, and financial tracking, and providing clear, timely status updates to study teams and management.
• Identify, assess, and manage operational risks, proposing practical mitigation strategies and supporting informed decision‑making to minimize impact to timelines, quality, and patient safety.
• Ensure inspection and audit readiness, including oversight of Trial Master File (TMF) set‑up, ongoing maintenance, and close‑out for CNS studies.
• Contribute to operational planning and regulatory deliverables, supporting preparation of study‑level documentation for Health Authority interactions and continuous improvement of clinical operations processes.

Qualifications

• Bachelor’s degree in a scientific or health‑related discipline.
• 5-8 years clinical trial management experience within an industry sponsor environment, supporting drug development programs.
• Experience managing clinical trials in CNS therapeutic development strongly preferred.
• Proven ability to manage global clinical studies, including coordination with investigators, CROs, and functional vendors.
• Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements applicable to clinical trials.
• Solid understanding of project management principles, including planning and managing timelines, resources, budgets, and risk–benefit trade‑offs; PMP or similar training is a plus.
• Excellent communication, collaboration, and interpersonal skills, with the ability to influence without formal authority and drive cross‑functional team performance.
• Demonstrated ability to manage multiple priorities in a fast‑paced environment, meeting aggressive timelines while maintaining quality.
• Proactive problem‑solving mindset with the ability to anticipate issues, identify creative solutions, and take initiative to address risks impacting timelines or budgets.

Compensation

The annual base salary range for the Clinical Trial Manager is $120,000 - $150,000.

The annual base salary range for the Senior Clinical Trial Manager is $145,000-$190,000.

Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The (Senior) Clinical Trial Manager is a remote role based in the US, with occasional travel (10% - 15%). 

POSITION: Full-Time, Exempt

Position

Manifold Bio is seeking an experienced drug development leader to guide strategy and execution of our shuttled oligonucleotide therapeutics programs. You will define and execute the strategic vision for our oligonucleotide therapeutic capabilities, leveraging our proprietary shuttle screening technology to discover and develop the next generation of  tissue-targeted oligonucleotide therapeutics. This role combines technical leadership of scientific staff focused on designing, screening, and evaluating tissue-targeted oligonucleotides, with strategic leadership of cross-functional drug discovery teams advancing lead molecules toward clinical testing.

Responsibilities

• Build and lead a fit-for-purpose oligonucleotide therapeutic discovery team that includes both internal and outsourced expertise and capabilities, as needed.
• Lead 1-2 cross-functional drug discovery project teams, collaborating closely with protein engineers, in vitro biologists, bioconjugation scientists, and in vivo biologists to discover and progress shuttled oligo-based therapeutics.
• Work with company leadership and cross-functional experts to prioritize high-value therapeutic targets for tissue-targeted oligo therapeutics. 
• Define best-in-class target product profiles for tissue-targeted therapeutic oligonucleotides. Define workplans and track progress to deliver on those target product profiles.
• Closely track advances in the field and provide strategic direction for continued development and expansion of Manifold’s shuttled oligo discovery efforts.
• Clearly communicate scientific progress and challenges to team members, leadership, and internal/external  collaborators
• Establish and optimize innovative,  efficient screening and production systems that leverage Manifold’s multiplexed in vivo screening capabilities. 
• Serve as oligonucleotide therapeutic subject matter expert  in discussions with potential partners, collaborators, and investors

Required Qualifications

• PhD in a relevant field (chemistry, biochemistry, nucleic acid chemistry/biology, biophysics, molecular biology, pharmacology or related discipline)
• Minimum of 10 years post-PhD experience, including experience in industry drug-discovery programs
• Diverse experience with multiple oligonucleotide modalities (ASOs, siRNAs, aptamers, mRNA), different backbone chemistries/modifications
• Knowledge of proven and emerging technologies for delivering oligo medicines to cellular targets (LNPs, passive or active targeting moieties, etc.)
• Experience progressing oligonucleotide therapies from early discovery through IND-enabling preclinical activities / early clinical development
• Demonstrated leadership of effective specialized and cross-functional scientific teams
• Demonstrated ability to mentor junior scientists
• Excellent written and verbal communication skills

Preferred Qualifications

• Experience designing and interpreting in vitro and in vivo systems assessing oligonucleotide efficacy and safety
• Strong background in the engineering of optimized oligonucleotide conjugates, including linker discovery and bioconjugation optimization 
• Experience building and/or optimizing platforms for oligo design, synthesis, and screening
• Understanding of DMPK, toxicology, developability, and CMC considerations specific to oligos
• Track record of successful partnerships and external collaborations

This Role Might Be Perfect For You If:You are energized by the opportunity to shape the future of a therapeutic modality, working at the intersection of cutting-edge shuttle technology and oligonucleotide medicine. You are a strategic scientific leader who thrives on building complex technical platforms and programs from the ground up. You combine deep oligonucleotide chemistry expertise with the vision and drive to establish new capabilities and lead cross-functional teams toward ambitious goals. You excel at balancing scientific rigor with the speed and agility needed in a dynamic biotech environment, making data-driven decisions that advance programs while managing multiple priorities and stakeholders.

If you’re excited to use unique technologies to shape an innovative drug development strategy, build meaningful industry partnerships, and contribute directly to our mission of advancing breakthrough treatments, please apply!

Base Salary Range: $195,000-239,000

This reflects the typical offer range for this role, based on experience, role scope, and internal equity. Final compensation decisions are made using a consistent leveling framework and consider the candidate’s experience, interview performance, and expected impact.

This role is eligible for:

• Annual performance-based target bonus
• Stock options
• Comprehensive medical, dental, and vision coverage
• 401(k) plan
• Flexible paid time off and holidays
• Perks including on-site gym, onsite lunch, and commuter support

Our compensation ranges are reviewed annually to ensure alignment with market trends and internal equity.

Motional is a leading autonomous driving company on a mission to make driverless vehicles a safe, reliable, and accessible reality. Backed by Hyundai Motor Group, Motional is at the forefront of the physical AI revolution. Motional isn’t just building first-of-its-kind technology; we are transforming transportation to create safer streets and more sustainable mobility options.

The Systems Readiness and Performance team is the crucial bridge between software development and real-world deployment. We are responsible for driving system design, for verifying and validating the autonomy stack, and for defining, measuring, and validating system performance targets. We work closely with stakeholders in autonomy, infrastructure, and operations to build the definitive safety case for the commercial launch of our fully driverless IONIQ 5 robotaxis in Las Vegas later this year.

Mission Summary:

The Autonomy Subsystems team at Motional is focused on designing and evaluating modules of the autonomy software. We are seeking a talented senior engineer to contribute to evaluation of our machine learning subsystems. Our team performs a variety of evaluations of machine learning models, including offline model eval, evaluation of open and closed-loop re-simulations, and assessment of on-road performance. Our goal is to establish metrics that describe autonomy subsystem performance, evaluate against those metrics to validate performance, and provide meaningful insight to ML developers and teams, working closely alongside them to improve the performance of ML models on the car.

We are looking for a highly-technical systems engineer with experience designing and evaluating safety critical systems and machine learning models. Bring your passion for autonomy, robotics, and machine learning to our team to help build a production-ready system and prepare for our scaled robotaxi service deployment.

Responsibilities:

• Define, prototype, and validate advanced metrics that bring new insights to model performance evaluation for autonomy subsystems (mainly focused on perception, prediction, and planning).
• Assess coverage of existing training and testing, then curate test sets that sufficiently capture Motional’s intended deployment operational design domain, across many axes (agent types, interaction types, map/spatial, etc.).
• Evaluate machine learning model performance against these metrics and tests.
• Assess system-level performance and subsystem contribution to system behavior through large-scale data analysis of on-road and simulation events.
• Define performance requirements for autonomy subsystems, and supporting analyses required to establish these targets.
• Coordinate subsystem-level evaluation with other system-level testing efforts across the systems team in support of the safety case and safety claims.
  
  

Qualifications:

• An engineer who has demonstrated strong cross-functional collaborative skills and is highly self-starting. This is a highly cooperative role across systems, autonomy, infrastructure, and other parts of the organization.
• Proven engineer with 5+ years of experience working on high-tech safety critical systems or robotics, ideally from a systems, robotics, or similar background.
• Master’s degree in relevant fields (systems, robotics, ML, CS, etc.) or Bachelor’s degree plus significant relevant in-field experience.
• Skilled Python developer, familiarity with analyzing the large scale data required to train and test ML models.
• Experience designing unique metrics that capture key aspects of system behavior and are used to enhance model development.
  
  

Bonus Skills:

• Experience training machine learning models, familiarity with state-of-the-art ML model architectures.
• Deep experience with a specific aspect of machine learning for autonomous robotics (perception, prediction, or planning).
• Knowledge of C++, especially applied to safety critical systems.
• Experience with systems verification and validation techniques
• Experience with regression testing updates to already-deployed software in a safety-critical environment.
• Experience with automotive standards (E.g: ISO 12207, ISO 26262, ISO 21448)
• Experience with software quality management and assurance activities (E.g: IATF 16949, ISO 9001)
• Thorough understanding of robotics systems including sensors, actuators, mechatronics and software systems
• Work in cross collaboration teams to address problems and find solutions
  
  

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk, or hear. The employee is occasionally required to stand and at times for long periods; walk; use hands to finger, handle, or feel; reach with hands and arms. The employee must occasionally lift and move up to 50 pounds.

Travel Requirements (greater than 20%):
Expected to travel for 1-2 weeks each quarter visiting all of our testing sites - mostly to LV, but also domestically as needed for the business.

Working Environment

The work environment characteristics described here represent those a team member encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The team member is regularly exposed to mechanical and computer parts. The team member is occasionally exposed to fumes and/or airborne particlesThe noise level in the environment is low to moderate. 

Motional AD LLC is an Equal Employment Opportunity employer and we welcome all qualified applicants.  All applicants will receive impartial consideration without regard to race, sex, color, national origin, age, disability, veteran status, genetic data, religion, gender identity, sexual orientation or other legally protected status.  Motional AD LLC is a Drug-free workplace.

Motional is a leading autonomous driving company on a mission to make driverless vehicles a safe, reliable, and accessible reality. Backed by Hyundai Motor Group, Motional is at the forefront of the physical AI revolution. Motional isn’t just building first-of-its-kind technology; we are transforming transportation to create safer streets and more sustainable mobility options.

The Systems Readiness and Performance team is the crucial bridge between software development and real-world deployment. We are responsible for driving system design, for verifying and validating the autonomy stack, and for defining, measuring, and validating system performance targets. We work closely with stakeholders in autonomy, infrastructure, and operations to build the definitive safety case for the commercial launch of our fully driverless IONIQ 5 robotaxis in Las Vegas later this year.

Mission Summary:

The Autonomy Subsystems team at Motional is focused on designing and evaluating modules of the autonomy software. We are seeking a talented senior engineer to contribute to evaluation of our machine learning subsystems. Our team performs a variety of evaluations of machine learning models, including offline model eval, evaluation of open and closed-loop re-simulations, and assessment of on-road performance. Our goal is to establish metrics that describe autonomy subsystem performance, evaluate against those metrics to validate performance, and provide meaningful insight to ML developers and teams, working closely alongside them to improve the performance of ML models on the car.

We are looking for a highly-technical systems engineer with experience designing and evaluating safety critical systems and machine learning models. Bring your passion for autonomy, robotics, and machine learning to our team to help build a production-ready system and prepare for our scaled robotaxi service deployment.

Responsibilities:

• Define, prototype, and validate advanced metrics that bring new insights to model performance evaluation for autonomy subsystems (mainly focused on perception, prediction, and planning).
• Assess coverage of existing training and testing, then curate test sets that sufficiently capture Motional’s intended deployment operational design domain, across many axes (agent types, interaction types, map/spatial, etc.).
• Evaluate machine learning model performance against these metrics and tests.
• Assess system-level performance and subsystem contribution to system behavior through large-scale data analysis of on-road and simulation events.
• Define performance requirements for autonomy subsystems, and supporting analyses required to establish these targets.
• Coordinate subsystem-level evaluation with other system-level testing efforts across the systems team in support of the safety case and safety claims.
  
  

Qualifications:

• An engineer who has demonstrated strong cross-functional collaborative skills and is highly self-starting. This is a highly cooperative role across systems, autonomy, infrastructure, and other parts of the organization.
• Proven engineer with 5+ years of experience working on high-tech safety critical systems or robotics, ideally from a systems, robotics, or similar background.
• Master’s degree in relevant fields (systems, robotics, ML, CS, etc.) or Bachelor’s degree plus significant relevant in-field experience.
• Skilled Python developer, familiarity with analyzing the large scale data required to train and test ML models.
• Experience designing unique metrics that capture key aspects of system behavior and are used to enhance model development.
  
  

Bonus Skills:

• Experience training machine learning models, familiarity with state-of-the-art ML model architectures.
• Deep experience with a specific aspect of machine learning for autonomous robotics (perception, prediction, or planning).
• Knowledge of C++, especially applied to safety critical systems.
• Experience with systems verification and validation techniques
• Experience with regression testing updates to already-deployed software in a safety-critical environment.
• Experience with automotive standards (E.g: ISO 12207, ISO 26262, ISO 21448)
• Experience with software quality management and assurance activities (E.g: IATF 16949, ISO 9001)
• Thorough understanding of robotics systems including sensors, actuators, mechatronics and software systems
• Work in cross collaboration teams to address problems and find solutions
  
  

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk, or hear. The employee is occasionally required to stand and at times for long periods; walk; use hands to finger, handle, or feel; reach with hands and arms. The employee must occasionally lift and move up to 50 pounds.

Travel Requirements (greater than 20%):
Expected to travel for 1-2 weeks each quarter visiting all of our testing sites - mostly to LV, but also domestically as needed for the business.

Working Environment

The work environment characteristics described here represent those a team member encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The team member is regularly exposed to mechanical and computer parts. The team member is occasionally exposed to fumes and/or airborne particlesThe noise level in the environment is low to moderate. 

Motional AD LLC is an Equal Employment Opportunity employer and we welcome all qualified applicants.  All applicants will receive impartial consideration without regard to race, sex, color, national origin, age, disability, veteran status, genetic data, religion, gender identity, sexual orientation or other legally protected status.  Motional AD LLC is a Drug-free workplace.

Motional is a leading autonomous driving company on a mission to make driverless vehicles a safe, reliable, and accessible reality. Backed by Hyundai Motor Group, Motional is at the forefront of the physical AI revolution. Motional isn’t just building first-of-its-kind technology; we are transforming transportation to create safer streets and more sustainable mobility options.

The Systems Readiness and Performance team is the crucial bridge between software development and real-world deployment. We are responsible for driving system design, for verifying and validating the autonomy stack, and for defining, measuring, and validating system performance targets. We work closely with stakeholders in autonomy, infrastructure, and operations to build the definitive safety case for the commercial launch of our fully driverless IONIQ 5 robotaxis in Las Vegas later this year.

Mission Summary:

The Autonomy Subsystems team at Motional is focused on designing and evaluating modules of the autonomy software. We are seeking a talented senior engineer to contribute to evaluation of our machine learning subsystems. Our team performs a variety of evaluations of machine learning models, including offline model eval, evaluation of open and closed-loop re-simulations, and assessment of on-road performance. Our goal is to establish metrics that describe autonomy subsystem performance, evaluate against those metrics to validate performance, and provide meaningful insight to ML developers and teams, working closely alongside them to improve the performance of ML models on the car.

We are looking for a highly-technical systems engineer with experience designing and evaluating safety critical systems and machine learning models. Bring your passion for autonomy, robotics, and machine learning to our team to help build a production-ready system and prepare for our scaled robotaxi service deployment.

Responsibilities:

• Define, prototype, and validate advanced metrics that bring new insights to model performance evaluation for autonomy subsystems (mainly focused on perception, prediction, and planning).
• Assess coverage of existing training and testing, then curate test sets that sufficiently capture Motional’s intended deployment operational design domain, across many axes (agent types, interaction types, map/spatial, etc.).
• Evaluate machine learning model performance against these metrics and tests.
• Assess system-level performance and subsystem contribution to system behavior through large-scale data analysis of on-road and simulation events.
• Define performance requirements for autonomy subsystems, and supporting analyses required to establish these targets.
• Coordinate subsystem-level evaluation with other system-level testing efforts across the systems team in support of the safety case and safety claims.
  
  

Qualifications:

• An engineer who has demonstrated strong cross-functional collaborative skills and is highly self-starting. This is a highly cooperative role across systems, autonomy, infrastructure, and other parts of the organization.
• Proven engineer with 5+ years of experience working on high-tech safety critical systems or robotics, ideally from a systems, robotics, or similar background.
• Master’s degree in relevant fields (systems, robotics, ML, CS, etc.) or Bachelor’s degree plus significant relevant in-field experience.
• Skilled Python developer, familiarity with analyzing the large scale data required to train and test ML models.
• Experience designing unique metrics that capture key aspects of system behavior and are used to enhance model development.
  
  

Bonus Skills:

• Experience training machine learning models, familiarity with state-of-the-art ML model architectures.
• Deep experience with a specific aspect of machine learning for autonomous robotics (perception, prediction, or planning).
• Knowledge of C++, especially applied to safety critical systems.
• Experience with systems verification and validation techniques
• Experience with regression testing updates to already-deployed software in a safety-critical environment.
• Experience with automotive standards (E.g: ISO 12207, ISO 26262, ISO 21448)
• Experience with software quality management and assurance activities (E.g: IATF 16949, ISO 9001)
• Thorough understanding of robotics systems including sensors, actuators, mechatronics and software systems
• Work in cross collaboration teams to address problems and find solutions
  
  

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk, or hear. The employee is occasionally required to stand and at times for long periods; walk; use hands to finger, handle, or feel; reach with hands and arms. The employee must occasionally lift and move up to 50 pounds.

Travel Requirements (greater than 20%):
Expected to travel for 1-2 weeks each quarter visiting all of our testing sites - mostly to LV, but also domestically as needed for the business.

Working Environment

The work environment characteristics described here represent those a team member encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The team member is regularly exposed to mechanical and computer parts. The team member is occasionally exposed to fumes and/or airborne particlesThe noise level in the environment is low to moderate. 

Motional AD LLC is an Equal Employment Opportunity employer and we welcome all qualified applicants.  All applicants will receive impartial consideration without regard to race, sex, color, national origin, age, disability, veteran status, genetic data, religion, gender identity, sexual orientation or other legally protected status.  Motional AD LLC is a Drug-free workplace.

Motional is a leading autonomous driving company on a mission to make driverless vehicles a safe, reliable, and accessible reality. Backed by Hyundai Motor Group, Motional is at the forefront of the physical AI revolution. Motional isn’t just building first-of-its-kind technology; we are transforming transportation to create safer streets and more sustainable mobility options.

The Systems Readiness and Performance team is the crucial bridge between software development and real-world deployment. We are responsible for driving system design, for verifying and validating the autonomy stack, and for defining, measuring, and validating system performance targets. We work closely with stakeholders in autonomy, infrastructure, and operations to build the definitive safety case for the commercial launch of our fully driverless IONIQ 5 robotaxis in Las Vegas later this year.

Mission Summary:

The Autonomy Subsystems team at Motional is focused on designing and evaluating modules of the autonomy software. We are seeking a talented senior engineer to contribute to evaluation of our machine learning subsystems. Our team performs a variety of evaluations of machine learning models, including offline model eval, evaluation of open and closed-loop re-simulations, and assessment of on-road performance. Our goal is to establish metrics that describe autonomy subsystem performance, evaluate against those metrics to validate performance, and provide meaningful insight to ML developers and teams, working closely alongside them to improve the performance of ML models on the car.

We are looking for a highly-technical systems engineer with experience designing and evaluating safety critical systems and machine learning models. Bring your passion for autonomy, robotics, and machine learning to our team to help build a production-ready system and prepare for our scaled robotaxi service deployment.

Responsibilities:

• Define, prototype, and validate advanced metrics that bring new insights to model performance evaluation for autonomy subsystems (mainly focused on perception, prediction, and planning).
• Assess coverage of existing training and testing, then curate test sets that sufficiently capture Motional’s intended deployment operational design domain, across many axes (agent types, interaction types, map/spatial, etc.).
• Evaluate machine learning model performance against these metrics and tests.
• Assess system-level performance and subsystem contribution to system behavior through large-scale data analysis of on-road and simulation events.
• Define performance requirements for autonomy subsystems, and supporting analyses required to establish these targets.
• Coordinate subsystem-level evaluation with other system-level testing efforts across the systems team in support of the safety case and safety claims.
  
  

Qualifications:

• An engineer who has demonstrated strong cross-functional collaborative skills and is highly self-starting. This is a highly cooperative role across systems, autonomy, infrastructure, and other parts of the organization.
• Proven engineer with 5+ years of experience working on high-tech safety critical systems or robotics, ideally from a systems, robotics, or similar background.
• Master’s degree in relevant fields (systems, robotics, ML, CS, etc.) or Bachelor’s degree plus significant relevant in-field experience.
• Skilled Python developer, familiarity with analyzing the large scale data required to train and test ML models.
• Experience designing unique metrics that capture key aspects of system behavior and are used to enhance model development.
  
  

Bonus Skills:

• Experience training machine learning models, familiarity with state-of-the-art ML model architectures.
• Deep experience with a specific aspect of machine learning for autonomous robotics (perception, prediction, or planning).
• Knowledge of C++, especially applied to safety critical systems.
• Experience with systems verification and validation techniques
• Experience with regression testing updates to already-deployed software in a safety-critical environment.
• Experience with automotive standards (E.g: ISO 12207, ISO 26262, ISO 21448)
• Experience with software quality management and assurance activities (E.g: IATF 16949, ISO 9001)
• Thorough understanding of robotics systems including sensors, actuators, mechatronics and software systems
• Work in cross collaboration teams to address problems and find solutions
  
  

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk, or hear. The employee is occasionally required to stand and at times for long periods; walk; use hands to finger, handle, or feel; reach with hands and arms. The employee must occasionally lift and move up to 50 pounds.

Travel Requirements (greater than 20%):
Expected to travel for 1-2 weeks each quarter visiting all of our testing sites - mostly to LV, but also domestically as needed for the business.

Working Environment

The work environment characteristics described here represent those a team member encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The team member is regularly exposed to mechanical and computer parts. The team member is occasionally exposed to fumes and/or airborne particlesThe noise level in the environment is low to moderate. 

Motional AD LLC is an Equal Employment Opportunity employer and we welcome all qualified applicants.  All applicants will receive impartial consideration without regard to race, sex, color, national origin, age, disability, veteran status, genetic data, religion, gender identity, sexual orientation or other legally protected status.  Motional AD LLC is a Drug-free workplace.

Summary/Primary Role:

This role is responsible for preparing accurate and competitive cost estimates for geothermal and mechanical construction projects. This role analyzes drawings, specifications, and subsurface data to develop detailed pricing for ground source heat pump systems, piping, drilling coordination, and associated mechanical scopes. The estimator works closely with preconstruction, engineering, and operations teams to support successful project pursuit and execution.

Principal Duties & Responsibilities:

(Management may amend or assign duties and responsibilities to this job at any time)

• Prepare detailed cost estimates for mechanical systems, including labor, materials, equipment, and subcontracted work.
• Analyze blueprints, specifications, and scopes of work to develop accurate cost estimates for labor, materials, equipment, and subcontractors related to mechanical systems, including HVAC, plumbing, and piping, in support of geothermal and energy infrastructure projects.
• Coordinate pricing and scope alignment with mechanical, electrical, and plumbing (MEP) contractors, specialty vendors, and suppliers.
• Participate in pre-bid meetings, site walks, and subcontractor audits as needed. Estimated travel requirement: up to 25%.
• Ideally has strong HVAC, plumbing, or piping backgrounds with the ability to provide support to onboard into geothermal-related work.
• Thorough knowledge of piping, plumbing and mechanical system operations.
• Estimating, budget, cost control, scheduling, and management of multiple bids.
• Solid understanding of wide variety of HVAC equipment and materials.
• Review construction drawings, specifications, geotechnical reports, and RFP/RFQ documents.
• Perform quantity takeoffs for piping, heat pumps, mechanical equipment, and related components.
• Analyze historical cost data and market conditions to ensure competitive pricing.
• Participate in pre-bid meetings, site visits, and scope reviews.
• Identify risks, value engineering opportunities, and constructability considerations.
• Collaborate with project managers and engineers to ensure smooth handoff from estimate to execution.
• Maintain estimating databases, templates, and cost libraries.
• Assist with post-bid reviews and cost variance analysis.
• All other duties and responsibilities as assigned.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Construction Management, or related field (or equivalent experience).
• 3–7+ years of mechanical estimating experience, preferably in geothermal or HVAC.
• Strong understanding of mechanical systems, piping, and HVAC equipment.
• Ability to read and interpret construction drawings and specifications.
• Proficiency in estimating software, CAD drawings and Microsoft Excel.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple bids and deadlines simultaneously.

Supervisory Responsibility: 

This position does not have supervisory responsibility.

Expected Hours of Work: 

An Employee is expected to work a minimum of forty (40) hours per week. Non-exempt employees are eligible for overtime pay in accordance with applicable wage and hour laws, while exempt employees may be required to work additional hours as necessary to fulfill their job responsibilities. Overtime requirements will be determined based on the operational needs of the organization. The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining an employee’s base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, years of relevant experience, education, credentials, and internal equity). Brightcore also offers a comprehensive set of benefits to compliment the base salary. The base annual salary range for this position is $100,000-$130,000 and is eligible for an annual performance-based bonus.

Travel Requirements:  

• Travel required up to 75% to work/project sites in the greater Northeast Region (but not limited to) of the United States.
• Lodging & travel reimbursement will be provided for overnight stays.

Work Environment:

• Work site setting.
• Office setting.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• This is a safety sensitive position.

What We’re Looking For

We are looking for an experienced Strategic Engagement Lead who thrives in a fast-paced environment.  Strategic Engagement is the value engine of Datavant Life Sciences. We are accountable for driving meaningful, measurable outcomes for our customers by aligning our products and services with their strategic objectives—maximizing value, accelerating time to patient and business impact, and fostering long-term, expansive relationships.  As such, we need an experienced relationship management individual who can drive success for our customers. 

This role includes responsibilities for commercial outcomes (e.g., value realization, customer satisfaction, renewals, etc.) and post-sale activities (e.g., delivery, adoption, advocacy, retention, etc.).

What You Will Do

• Own account management and value management for a dedicated account portfolio of up to 15 accounts in our biopharma segment, with a special focus on end-to-end acceleration of value within your portfolio.
• Lead with curiosity and dive deep into learning and understanding the goals and strategies of our customers and how our solutions and products support those goals
• Excel in advanced program management and decision-making, balancing thoughtful analysis with speed to execution, appropriately prioritizing, and knowing when and how to escalate complex edge cases effectively
• Influence future lifetime value through higher product adoption, customer satisfaction and overall health scores
• Thrive in a fast-paced, continuous improvement environment, embracing gray areas and ambiguity, while seeking to drive clarity and scalability for your customers and the business
• Work effectively with your cross-functional partners - surfacing insights that influence product and sales strategies across account teams for your portfolio accounts.
• Take a self-service-first approach to problem solving and navigating questions internally and externally
• Be a proven communicator and presenter with a commitment to maintaining good  internal and external relationships through passion, empathy, and hard work
• Help create a company-wide culture of customer-centricity

What You Need to Succeed

• 7+ years experience in healthcare technology and customer facing roles (required)
• Proven ability to build deep, trust-based relationships with customer stakeholders
• Seasoned strategic program and project manager focused on connect the dots thinking that puts client value at the center of everything
• Skilled at expanding relationships beyond direct contacts through rapport-building
• Demonstrated ownership of complex, high-value customer accounts
• Strategic thinker who connects cross-customer trends to shape value propositions.
• Effective and empathetic internal and external communication
• Previous experiencing working in one or more of the following areas (required):
  • Experience working within RWD health analytic companies, CROs, or systems integrators in the healthcare sector
  • Application of RWD and RWE in the pharmaceutical and life sciences space
  • Understanding of drug development and/or clinical trials
• Living within commutable distance to our office in Boston, MA and able to commute to the office and to client sites periodically

#LI-BC1

🌟 Now Hiring: Electrical Automation Specialist / Maintenance Technician!

📍 Galena, KS
🏭 PBI-Gordon Corporation

Ready to own your impact and work with cutting‑edge automation that keeps an industry leader moving?
PBI-Gordon is looking for a skilled Maintenance Technician with strong Industrial/Electrical/PLC expertise to join a team where innovation, safety, and pride drive every day.

⚡ What You’ll Do

Jump into a role where no two days are the same — you’ll be the go‑to expert for keeping our automated production systems performing at their best, including:
🔧 Installing, maintaining & repairing production machinery
⚙️ Troubleshooting mechanical, electrical, pneumatic & hydraulic systems
🖥️ Programming & maintaining PLCs, HMIs, VFDs & robotics (Studio 5000, RSLogix, FactoryTalk)
📘 Reading electrical schematics, blueprints & ladder logic
🛠️ Preventative maintenance + diagnosing issues before they become problems

🎯 What You Bring

You’re the kind of person who thrives in a hands‑on environment and loves solving tough technical challenges. We’re looking for:
✔️ 7+ years in production maintenance & automation
✔️ Strong Industrial/Electrical/PLC training or equivalent experience
✔️ Master‑level mechanical, electrical, pneumatic & industrial maintenance skills
✔️ Ability to lift 55+ lbs & operate forklifts

💼 What You’ll Get

We don’t just offer a job — we offer ownership. Literally.

🌟 Competitive Pay + Performance Rewards
🌟 Full Benefits: Medical, Dental, Vision, Life, Disability, FSA & even Pet Insurance
🌟 Generous PTO, Paid Holidays & Parental Leave
🌟 Employee Ownership (ESOP): The company invests in your retirement by contributing about 18% of your pay—at no cost to you.
🌟 Fitness & Tuition Reimbursement
🌟 A culture built on pride, partnership & growth

🚀 Ready to Build, Program & Elevate the Future of Automation?

Bring your Industrial/Electrical/PLC expertise to a company that values technical excellence and gives you the tools to grow.

👉 Apply Today & Power the Future with PBI-Gordon.

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-AD1

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-AD1

Your impact:

High visibility role as DSPV Operations Lead, will play a critical, strategic and hands-on operational role in supporting PV across all clinical development programs.  

Your day-to-day:  

Clinical Trial Support

• Lead the process for Individual Case Safety Report (ICSR) collection, processing, reconciliation, submission and distribution ensuing compliance with regulatory timelines and global regulations and guidelines
• Oversee reconciliation activities between the safety and clinical databases, as well as business partner safety data exchange
• Identify and support the development of Safety Management Plans (SMPs), and other study specific project plans
• Work closely with Data Management of EDC development for the purposes of safety data collection including Annotated CRF reviews and associated activities.
• Collaborate with DSPV Safety Science and Data Management to prepare safety data listings and reports as needed and to participate in QC related to safety data for various reports and deliverables
• Collaborate cross-functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, and other relevant teams to ensure appropriate PV processes are in place and adhered to
• Prepare and deliver training on SAE reporting processes and practices at Investigator Meetings, to CRAs, to CROs, sites, as applicable.
• Lead DSPV Trial Master File document review, QC and provision to study specific TMFs
• Support DSUR preparation by maintaining DLP and submission calendar, supporting Kick-Off Meeting activities, requests for and attainment of information from cross-functional teams
• Assist with DSPV Operational processes and initiatives, representing PV Operations in collaboration with other functions as needed.

Vendor Management

• Lead day-to-day operational oversight of pharmacovigilance service provider
• Establish and/or maintain oversight of key performance indicators (KPIs), key risk indicators (KRIs), key quality indicators (KQIs), and routine operational reports
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities, and functional goals
• Obtain close oversight of ICSR quality including performance of QC as needed
• Oversee safety database configuration updates, system updates, maintenance, E2B gateway implementations, user account management, back-up testing, and other activities as required
• Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA compliance

Quality and Compliance

• Support the development, review, and maintenance of Standard Operating Procedures (SOPs) / Work Instructions (WIs) for DSPV.
• Support PV audit and inspection activities, as required, and serve as SME for DSPV Operations during these activities
• Ensure DSPV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and PVAs.
• Maintain a comprehensive DSPV Quality Management System aligned with DSPV functional goals
• Prepare and present DSPV Compliance Reports to DSPV/QA forum, highlighting trends, issues, and opportunities for improvement

Must-Haves:

• Degree in Life Sciences, Pharmacy, Nursing or related field
• 8+ years of experience in PV in Biotech, Pharma, or a CRO
• 5 years of experience working with and providing oversight to PV vendors and/or hosting partners.
• Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER).
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance.
• Effective collaboration and interpersonal skills.
• Ability to work independently, establish work priorities, and execute decisions with minimal guidance
• Excellent decision-making and analytical skills.

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $170,000 to $185,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

This position is located at:

The LPN/LVN supports patient care before, during, and after procedures, assists surgical teams, and ensures safety, compliance, and premium patient experience. This role is central to clinic operations, patient education, and quality improvement efforts. 

Qualifications: 

• Graduate of an accredited program; current state licensure required. Active Compact Nursing License accepted in lieu of state-specific licensure. 

• Maintains active license and meets renewal requirements. 

• ACLS certification required. 

• Proficient in Microsoft Office and electronic health records. 

• Preference to have Post Op and/or OR Circulator experience.  Not required, will train on job.   

Key Responsibilities: 

Patient Care & Clinical Support 

• Assist with pre-op and post-op visits and surgical procedures. 

• Educate patients on pre/post-operative care, recovery bundles, and clinic protocols. 

• Monitor patient responses and escalate concerns to RN or Physician. 

• Maintain clinical documentation and patient confidentiality (HIPAA compliance). 

• Support clinic safety protocols and sterilization procedures. 

Procedural Support 

• Prepare OR setup, patient positioning, and surgical tools. 

• Maintain accurate intraoperative documentation (e.g., Time Out, surgical notes). 

• Support laser safety, drug labeling, and equipment handling. 

• Assist with post-procedure cleaning, dressing application, and patient discharge. 

Administrative & Operational 

• Track and manage medical supplies and equipment. 

• Use Sono Bello tools (Manuals Portal, QM, etc.) for compliance and documentation. 

• Attend staff meetings, trainings, and complete all required certifications. 

• Assist with photography uploads, appointment scheduling, and general clinic duties. 

Additional Expectations: 

• Maintain professionalism, patient rapport, and sound clinical judgment. 

• Understand and enforce OSHA, AAAHC, and company quality standards. 

• Participate in clinic performance goals and KPIs. 

• Stay current on company policies, procedures, and safety manuals. 

Skills & Abilities: 

• Effective communication, documentation, and organizational skills. 

• Competency in infection control, wound assessment, and emergency response. 

• Ability to lift up to 25 lbs., work on feet, and manage high-paced clinical environments. 

• Demonstrated reasoning, math, and problem-solving aptitude. 
  
  

Note: This job description outlines the primary duties and responsibilities of the role but is not intended to be all-inclusive. Additional tasks may be assigned, and existing responsibilities may be modified or removed as necessary to meet operational needs, within the scope of the individual’s role, licensure, and applicable regulatory standards. 

Pasek Security, a DH Pace Company, Inc. is hiring an experienced Entry Door Technician at our office in Boston, MA to service a variety of entry doors and door hardware. You must be able to troubleshoot, work without supervision, and have great attention to detail. Valid driver’s license required with a good driving record.

Job Responsibilities:

•  Service all products, to include doors and dock equipment cleanly and accurately
•  Identify opportunities to provide customers with products and services
•  Tracking and maintaining job related paperwork and submitting in a timely manner
•  Always operating in safety conscious manner while performing job duties
•  Other responsibilities as assigned

Job Qualifications:

• High school diploma or equivalent preferred
• Able to safely lift 100 pounds over your head
• Commercial door experience and welding experience is a plus but not required
• Must possess valid driver’s license and good driving record

HIRING BONUS! $1,000 OR $2,500 WITH VERIFIABLE INDUSTRY EXPERIENCE AS COMMERCIAL DOOR INSTALLER!

Overhead Door Company of Boston™, a DH Pace Company, Inc., is seeking a experienced Commercial Door Installer at our Rockland, Massachusetts location. In this position, you will be responsible for the repair and/or installation of a variety of building materials, commercial doors, and door hardware.

If you have experience working with commercial doors including roll-up doors, high-speed doors, door hardware, dock equipment, dock levelers, or any similarly skilled trades in the commercial construction industry, please apply!

Job Responsibilities:

• · Install a wide range of commercial doors and door hardware including roll up doors, dock doors, dock equipment, high speed rolling doors and commercial entry doors
• · Identify opportunities to provide customers with products and services
• · Track and maintain job related paperwork and submitting in a timely manner
• · Always operate in safety conscious manner while performing job duties
• · Other responsibilities as assigned

Job Requirements:

• · High School Diploma/GED (Preferred)
• · Prior experience in a similar role or one that required a mechanical aptitude preferred
• · Ability to safely lift 100 pounds
• · Ability to work at heights and use a ladder
• · Must possess valid driver’s license and good driving record

Pasek Security, a DH Pace Company, Inc. is hiring an experienced Entry Door Technician at our office in Salem, NH to service a variety of entry doors and door hardware. You must be able to troubleshoot, work without supervision, and have great attention to detail. Valid driver’s license required with a good driving record.

Job Responsibilities:

•  Service all products, to include doors and dock equipment cleanly and accurately
•  Identify opportunities to provide customers with products and services
•  Tracking and maintaining job related paperwork and submitting in a timely manner
•  Always operating in safety conscious manner while performing job duties
•  Other responsibilities as assigned

Job Qualifications:

• High school diploma or equivalent preferred
• Able to safely lift 100 pounds over your head
• Commercial door experience and welding experience is a plus but not required
• Must possess valid driver’s license and good driving record

#PaceID2

Role Overview 

We are seeking highly skilled, and motivated Director of Combination Product & Device Development, to lead the development, manufacturing, assembly and commercialization of high‑concentration biologic delivery systems, including, prefilled syringes, autoinjectors and other drug–device combination products.

The ideal candidate brings deep expertise in device design control, verification and validation, risk management, combination product regulations, and human factors engineering. This role requires hands‑on technical leadership and extensive experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366, ANSI/AAMI HE75) and FDA guidance. A successful track record supporting major regulatory submissions (BLA, MAA, IND/IMPD) and notified body assessments is essential.

Key Responsibilities 

Device Development

• Lead end‑to‑end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
• Drive design control documentation, risk assessments, usability studies, and human factors integration.
• Collaborate deeply with internal partners across CMC, drug product development, quality assurance, regulatory affairs, clinical development, supply chain, and commercial functions.
• Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.
• Support lifecycle management of commercial combination products, including design history file (DHF) maintenance, change control, validation activities, complaint investigations, and post‑market surveillance.
• Evaluate technical decisions for cross‑functional impact and implement contingency plans as needed.
• Proactively identify and address manufacturing issues; coordinate technical solutions across internal and external teams.
• Lead creation of design control deliverables to ensure compliance with global device and combination product regulations.
• Oversee development of statistically sound verification protocols, reports, and design validation strategies.
• Lead or contribute to investigations of deviations, failures, complaints, and device‑related quality issues.

Design Controls & Human Factors

• Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
• Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
• Ensure all human factors processes, deliverables, and standards are appropriately documented within the Design Control Quality System.
• Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.
• Manage and prioritize multiple concurrent projects, ensuring alignment to scope, timelines, budgets, and quality standards.

Regulatory Support

• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks (e.g., EDDO, MDR).
• Author device‑related sections for regulatory submissions (BLA, MAA, IND/IMPD) and support notified body interactions.
• Represent the combination product function during regulatory audits and inspections.
• Lead proactive risk identification, mitigation planning, and escalation of critical issues.
• Demonstrate strong understanding of FDA’s Office of Combination Products (OCP), including primary mode of action (PMOA) requirements and combination product complaint expectations.

Qualifications 

• Master’s degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 15+ years of experience in biologic delivery device development with a proven record of supporting late‑stage development and commercial product launches.

• Experience with design controls, device risk management, medical devices, prefilled syringes, autoinjectors, and related scientific and technical concepts and techniques is required for this position.
• Deep knowledge of subcutaneous delivery systems, systems engineering principles, device materials, and manufacturing technologies; experience with biologics and packaging development preferred.
• Strong understanding of FDA and EU regulations for medical devices and combination products, including relevant quality systems and standards.
• Experience managing external partners, vendors, and contract manufacturers.
• Proven experience with cGMP process development, manufacturing controls, and process risk assessments.
• Excellent communication, leadership, and cross‑functional collaboration skills.
• Ability to thrive in a fast‑paced, agile environment; start‑up experience is highly desirable.

Position Location 

This is a fully remote role with up to 15-20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

ESSENTIAL JOB FUNCTIONS:

The Senior Director of Pharmacovigilance (PV), Safety Sciences & Surveillance, provides strategic and operational leadership for global safety surveillance activities across Kura’s clinical and post-marketing programs. This individual is responsible for signal detection and evaluation, benefit-risk assessment, and safety surveillance strategies, for the company’s products. This role ensures compliance with global pharmacovigilance regulations and drives proactive risk management to protect patients and support product development.

This position partners cross-functionally with Clinical Development, Nonclinical, Regulatory Affairs, Biostatistics, and Quality to ensure robust safety oversight throughout the product lifecycle

Strategic Leadership

• Lead the Safety Sciences/Surveillance function, setting strategies for signal detection, risk management, and aggregate safety reporting.
• Lead safety strategy contributions to regulatory submissions, and lifecycle management strategies.
• Serve as safety lead on cross-functional governance committees (e.g., Safety Monitoring Committees).

Safety Surveillance & Signal Management

• Drive the development and continuous evolution of safety signal detection methodologies and product-specific signaling strategies. 
• Lead signal validation, prioritization, and assessment processes in alignment with global regulations; interpretation of safety signals and trends; communication of safety assessments (written and verbal) of safety risks in collaboration with other functional stakeholders.

Risk Management & Regulatory Strategy

• Provide strategic oversight for Risk Management Plans (RMPs), REMS (if applicable), and other risk minimization activities.
• Serve as safety representative in interactions with global regulatory authorities.
• Ensure inspection readiness and support health authority audits/inspections.

Aggregate Reporting & Safety Communications

• Oversee preparation and review of aggregate safety reports (DSURs, PSURs/PBRERs, aggregate reports for anticipated events).
• Ensure alignment of safety messaging across clinical, regulatory, and medical communications.
• Provide strategic direction of safety content for key regulatory documents (e.g., DSURs, PSURs, IBs, protocols, RMPs) ensuring consistency and scientific rigor.

Cross-Functional Collaboration

• Partner with Clinical Development on safety monitoring strategies and DMC interactions.
• Collaborate with Biostatistics on integrated safety analyses.
• Provide safety expertise to Medical Affairs and Commercial teams for post-marketing surveillance, as needed.

Compliance & Quality

• Maintain oversight of safety vendors and CROs supporting surveillance activities.
• Contribute to SOP development and continuous improvement of PV systems and processes.
• Support inspection readiness activities, internal audits and external inspections.

Team Leadership

• Mentor and develop a high-performing Safety Sciences team.
• Foster a culture of scientific rigor, accountability, and patient focus.
• Manage departmental budget and resource planning.

JOB SPECIFICATIONS:

• PharmD or PhD in life sciences preferred.
• Advanced clinical or regulatory training highly desirable.
• 12+ years of experience in pharmacovigilance or drug safety.
• 5+ years in leadership roles within Safety Sciences, Signal Detection, or Safety Surveillance.
• Experience supporting global regulatory submissions and health authority interactions preferred.
• Strong background in oncology required.
• Experience in both clinical development and post-marketing safety preferred.
• Strong knowledge of signal detection methodologies and benefit-risk assessment.
• Experience in the principles and techniques of data analysis, proficient in the use of data analysis/visualization software.
• Working knowledge of industry standard safety databases, Regulatory databases, and other electronic data capture systems; working knowledge of MedDRA and WHODrug dictionaries.
• Proven experience authoring and reviewing aggregate safety reports.
• Demonstrate a deep understanding of and ensure compliance with current global PV regulations (FDA, EMA, CIOMS, ICH E2 guidelines).
• Strategic thinker, a self-starter with strong scientific judgment.
• Executive presence and ability to influence cross-functional stakeholders.
• Excellent written and verbal communication skills.

The base range for a Senior Director is $274,000 - $330,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

The Perfect Addition to Our Team

You are a seasoned leader in the pharmaceutical industry who is eager to shape and implement clinical outsourcing strategies for clinical trials. You are well organized and collaborative, able to work seamlessly with teams to drive our clinical activities. You thrive in a fast-paced environment, juggling priorities, and stepping in wherever needed. With a proven track record in scaling operations within biotech or pharmaceutical settings, you are a results-driven problem solver who efficiently connects problems with solutions. Your strong interpersonal skills enable you to build effective relationships inside and outside the company. If you're passionate about making a difference and driving results, we want to hear from you!

The Opportunity

The Associate Director, Clinical Outsourcing, will be responsible for development and execution of Entrada’s clinical outsourcing strategy and will manage vendor outsourcing, negotiation, and contracting for Entrada clinical studies. This role reports to the Executive Director, Clinical Business Operations, and sits within the Clinical and Business Operations and Biometrics department.  The successful candidate for this role will demonstrate an in-depth knowledge of outsourcing models and strategies, negotiations and contracting, study financials, and cost-effective best practices, as well as a thorough understanding of clinical operations, clinical trial services, and clinical technologies.

Responsibilities

• Develop Entrada’s long-term Outsourcing strategy in support of the DMD and Ocular Franchises, inclusive of full-service CROs, functional service providers, bioanalytical laboratories, ancillary services and technology service providers.
• Independently lead and be accountable for the vendor selection and onboarding process, including preparing RFPs, leading the review of proposal responses, conducting complex budget analysis comparisons and negotiations, and coordinating vendor qualification with QA.
• Identify opportunities to reduce costs, increase efficiency, and mitigate risk related to outsourced services across the portfolio.
• Lead and manage large, complex contract and financial negotiations with external service providers (including detailed scopes of work, exhibits, payment terms, budgets, and change orders) to ensure favorable terms and risk mitigations.
• Manage review and negotiation of contract business terms and partner with internal stakeholders, Legal, and Finance as needed to finalize terms and obtain approvals.
• Support development and negotiation of MSAs, quality agreements, and vendor oversight plans.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• Bachelor’s degree in life sciences, business, or a related field; advanced degree preferred.
• 10+ years of progressive leadership experience in clinical operations or related areas, with at least eight years of clinical operations or outsourcing experience.
• Expert in outsourcing and contracting best practices for all phases of clinical research with an in-depth understanding of the drug development process and cross-functional responsibilities, including clinical trial design, study start-up and execution, monitoring, and site management, safety reporting, data management, and biometrics.
• In-depth experience soliciting and critically evaluating CRO and service provider proposals, negotiating contractual terms, and growing and fostering long-term, healthy vendor relationships.
• Strong attention to detail, analytical, negotiation, and business communication skills.
• Ability to interact and influence effectively with multi-functional teams at all internal and external organization levels.
• Forward-thinking and creative with high ethical standards.
• Ability to work in a fast-paced professional environment with changing priorities and business needs.
• Strong problem-solving and multi-tasking skills.
• Well-organized and self-directed.
• This is a US based remote position with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity. We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset.

But we also know it is more than just pay. When you join Entrada, you’ll be part of a mission-driven team with access to comprehensive health, dental and vision coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions – offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model. If you find yourself working from our office in Boston’s Seaport District, this puts you steps away from some of the best the city has to offer.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $173,000-$203,000. The final base compensation offered will depend on several considerations which include but may not be limited to a candidate’s skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range. #LI-JF1 #LI-Remote 

Location: Galena, KS
Schedule: On-site | Monday–Friday | 6:30 AM – 3:30 PM

Position Summary

The EHS Specialist plays a key role in supporting day-to-day environmental, health, and safety activities at the site, with a focus on incident management, employee training, and maintaining a safe, compliant work environment.

This is a hands-on role that partners closely with site leadership, employees, HR, and the broader EHS team to drive safety awareness, support compliance efforts, and ensure follow-through on key initiatives.

This position is ideal for someone who is detail-oriented, proactive, and looking to gain experience in EHS within a structured and supportive environment.

Compensation & Benefits 

• Employee Ownership (ESOP): Company-funded retirement contribution of approximately 18% of pay, plus 401(k) 
• Competitive base salary with performance-based bonus opportunity 
• Comprehensive benefits package: Medical, Dental, Vision, Life, Disability, FSA, and Pet Insurance 
• Generous paid time off, paid holidays, and parental leave 
• Fitness and tuition reimbursement programs
• Relocation assistance available 

Essential Duties & Responsibilities

• Incident Management & Follow-Through
  • Support the incident reporting process, including documentation, investigation participation, and corrective action tracking
  • Partner with site leaders and HR to identify root causes and support practical corrective actions
  • Monitor corrective actions to completion and escalate risks or delays as needed
  • Apply sound judgment when assessing risk and determining when to escalate
• Training & Employee Engagement
  • Deliver monthly EHS training sessions aligned to site and regulatory requirements
  • Identify training gaps and support development of site-specific content
  • Track and report training completion and effectiveness
  • Provide coaching and support to employees in a positive, approachable manner
• Compliance & Site Support
  • Support regulatory compliance activities, including inspections, documentation, and follow-up
  • Assist with audits, corrective actions, and site-level EHS initiatives
  • Support small EHS projects in collaboration with the EHS team
  • Participate in regular safety meetings with site leadership
•  Partnership & Communication
  • Build strong working relationships with site leaders, HR, and employees
  • Prepare for and participate in safety and EHS team meetings
  • Communicate clearly, proactively, and professionally across stakeholders

Required Qualifications

• 2–5 years of experience in EHS, safety, or a related role within manufacturing, industrial, or similar environments
• Working knowledge of OSHA, EPA, and/or DOT requirements
• Experience supporting safety programs, incident tracking, training, or compliance activities
• Strong organizational skills and follow-through
• Ability to work independently while knowing when to escalate
• Effective communication and collaboration skills
• High School Diploma

Preferred Qualifications

• Bachelor’s degree in Safety, Environmental Science, Chemistry, or related field
• Professional certification (ASP, CSP, CHMM, CIH, or similar)
• Experience in a multi-site or team-based EHS environment

Work Environment & Culture 

PBI-Gordon Companies offers a collaborative, employee-owned environment where accountability, partnership, and continuous improvement are valued. Team members are encouraged to contribute ideas, develop professionally, and grow their careers alongside the business. 

Equal Opportunity Employer 

PBI-Gordon Companies is an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive environment for all employees. 

If you're motivated by creating safe workplaces through compliant EHS practices, positive employee engagement, and consistent follow-up, we'd love to hear from you. 

Apply today to join an employee-owned organization that values accountability, partnership, and continuous improvement. 

Summary/Primary Role:

This role provides a unique opportunity to work with state-of-the-art drilling technologies, while gaining hands-on training directly from a Geothermal Driller. The ideal candidate is comfortable handling drill pipe and casing, operating auxiliary equipment and following all safety and quality regulations and instructions. They will be working outdoors in all weather elements.

Principal Duties & Responsibilities:

(Management may amend or assign duties and responsibilities to this job at any time)

• Assisting with demobilization of equipment.
• Mixing drilling mud and grout.
• Handling drill pipe and casing.
• Operating auxiliary equipment between projects.
• Assist with loading and unloading of equipment and material.
• Driving company vehicles to and from job sites.
• Assist with drilling procedures on the drilling platform.
• Follow all safety and quality regulations and instructions.
• Keep equipment and drilling platform clean and orderly.
• Perform maintenance tasks at specified intervals.
• Perform inventory (stock intake) as required.

• Hauling, lifting (60-80 lbs.), moving, loading, and digging materials and equipment.
• Requires standing and bending for extended periods of time.
• Comfortability working outdoors in all elements.
• All other duties and projects as assigned.

Qualifications:

• Ability to operate heavy machinery.
• Ability to safely lift weights of 50+ pounds overhead.
• Must have an OSHA 30; SST card and Flagger certification strongly preferred or the ability to obtain.
• Must have an active Driver’s License with the ability to obtain CDL.
• Must be able to obtain coverage under company automobile insurance policy (clean driving record, certain age restrictions may apply).
• Eager to build a career in drilling and renewable energy.
• Willingness to get your hands dirty and engage in constant physical labor.
• Rigging experience, Mechanical skills, Welding skills are preferred but not required.

Supervisory Responsibility: 

This position does not have supervisory responsibility.

Expected Hours of Work & Salary:

An Employee must work a minimum of thirty (30) hours each week to maintain full-time status for benefits purposes, however the expectations of the position will require an average of forty (40) hours with overtime required as scheduled. The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining an employee’s base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, years of relevant experience, education, credentials, and internal equity). Brightcore also offers a comprehensive set of benefits to compliment the base salary. The hourly hiring range for this position is $35.50-$37.00.

Travel Requirements:  

• Travel required 100% in the greater Northeast Region of the United States - CT, MA, NY, ME, VT, NH, NJ
• Must be willing to be away from home Monday through Friday & scheduled Saturdays.
• Lodging & travel reimbursement will be provided for overnight stays.

Work Environment:

• Work site setting.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

• This is a safety sensitive position.

Note:

This position may be referred to by a different title (Tool Pusher, Driller Helper or Construction Laborer) though the responsibilities align with the role described above.

ESSENTIAL JOB FUNCTIONS:

• Leads the planning and execution of a complex, global clinical trial from start-up through close-out, in compliance with regulations/SOPs, within budget and timelines.
• Provides oversight and guidance to clinical operations personnel assigned to the clinical trial.
• Partners closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions to ensure aligned and efficient trial execution.
• Establishes strong relationships with investigators and KOLs.
• Contributes to the development and review of key study documents including protocols, ICFs, monitoring plans, EDC specifications and statistical analysis plans.
• Contributes to the selection of vendors and CROs. Manages and oversees CROs, vendors, and other external partners to ensure high-quality performance and adherence to expectations.
• Develops, manages, and tracks clinical trial budgets, ensuring studies are delivered within approved financial parameters.
• Provides regular, clear updates on study status, risks, and milestones to senior leadership and key stakeholders.
• Proactively identifies operational risks and implements mitigation strategies to maintain timelines, quality, and compliance.
• Supports and facilitates execution of contracts, clinical trial agreements, and study budgets.
• Direct manager of approximately 1-2 direct reports.
• Provides expert input into the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
• Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
• Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
• Complete other duties as assigned by the manager.

JOB SPECIFICATIONS:

• Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
• 10+ years of strong hands-on experience leading large, complex Phase 3 clinical trials preferably in oncology/hematology in US, Asia, Europe; or equivalent combination of training and experience.
• Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
• In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Flexibility to travel domestically and internationally as required.
• Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
• Experience setting up clinical trials outside of US and Europe is a plus.
• Field monitoring and/or clinical data management experience preferred.
• Proficiency with Microsoft Project

The base range for a Director is $228,000 - $252,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

About the role: 

Superluminal Medicines, Inc. is seeking a highly organized, detail oriented, and experienced Head of Compound and Data Management to help us build fully integrated, automated, and data-driven compound management and assay biology workflows. This role is essential to ensure that the scientists can focus on the science and trust that every experimental data point that is collected is underpinned by confidence in the compounds being tested. The person that fills this role understands how fundamental and critical compound management is to the experimental data being generated and how important data capture, recording, and communication is to drug discovery. 

Superluminal’s platform aims to develop candidate-ready compounds with unprecedented speed using a combination of deep biology, computational and medicinal chemistry, machine learning, and proprietary big data infrastructure. This role will sit at the interface of biology, chemistry, and technology and requires the candidate to have experience in cross-functional collaborations. The ideal candidate is highly motivated, thrives in a startup environment, and brings strong experience in management.

Key responsibilities: 

• Key business partner to chemistry, biology, and digital data & technology (DDT) groups
• Oversees strategy, roadmaps, and long-term plans of the group
• Participate in project team meetings to anticipate and respond to needs and keep the team informed of capabilities and bottlenecks
• Manage external CRO relationships and internal compound manager
• Lead the build of internal compound management capabilities
• Collaborate with biology and DDT to:
• establish dashboards, new CDD vault protocols, run-booking systems, data pipelines, etc.
• develop harmonized experiment templates, assay workflows, and metadata models to ensure scientific and operational consistency across projects
• improve process from plate maps to CDD upload
• improve integration across ELN/instruments/CDD
• Own the assay tracking Smartsheets across programs
• Investigate new automation, LCMS, and other capabilities. Develop a business case as appropriate and lead new capability builds if approved.
• Assist leadership with laboratory expansion planning and scaling strategy and ensure efficient execution
• Ensure compliance with all laboratory safety requirements including OSHA, biosafety, chemical hygiene and other regulatory standards
• Identify inefficiencies in our operational processes and implement solutions to address them

Qualifications & Skills:                                                                                                                                                                                                                                                                 

• Bachelor’s degree in Biology, Chemistry, or closely related field with 10+ years of industry experience or M.S. degree with 7+ years of industry experience
• Experience managing direct reports, CROs and key stakeholders
• Experience building or overseeing compound management capabilities 
• Experience with laboratory automation
• Experience managing lab buildouts or expansions
• Experience with research informatics, data science, or scientific programming is a plus
• Experience with compound shipping logistics, particularly with international shipments and customs documents a plus
• Highly organized self-starter with a strong ability for problem solving and effective execution
• Strong communication skills and ability to work effectively across multiple tasks
• Ability to work onsite full-time

Location: Boston, MA preferred

The Director, Biostatistics serves as a senior individual contributor to statistical leadership at Vor Biosciences, providing strategic and operational oversight across multiple clinical programs. Reporting to the Head of Biometrics this individual will serve as Vor's global expert in biostatistical science, with accountability for all aspects of clinical trial design, statistical methodology, regulatory submission deliverables, and cross-functional scientific partnership. This is a hands-on, high-impact role in a lean, mission-driven biotech environment where the Director will function as a study and program statistical lead with both technical depth and enterprise-wide strategic influence. 

Key Responsibilities 

1. Statistical Strategy & Clinical Trial Design

• Serve as the study and program-level statistical lead for one or more clinical programs, with end-to-end biostatistical ownership from study design through regulatory submission.
• Develop, author, and co-author statistical analysis plans (SAPs), sample size justifications, randomization strategies, and adaptive or novel trial design frameworks suited to rare disease and small-population contexts.
• Apply innovative statistical methodologies including Bayesian approaches, adaptive designs, andestimandframeworks per ICH E9(R1) to maximize information efficiency in limited-sample studies. 
• Collaborate with Clinical Development, Translational Science, and Clinical Pharmacology to integrate quantitative evidence from early development into late-stage design decisions.
• Provide statistical input to clinical development plans, protocol design, go/no-go decision frameworks, and feasibility assessments.

1. Regulatory Affairs & Submission Leadership

• Author and review statistical sections of regulatory documents including INDs, investigator brochures, briefing books, CSRs, and eCTD/CTD module submissions to FDA, EMA, and other health authorities.
• Represent Vor's Biostatistics function, asappropriate, in regulatory agency meetings (FDA Type A/B/C meetings; EMA scientific advice), preparing statistical positions and responding to agency questions.
• Ensure compliance with applicable ICH guidelines (e.g.,E6, E8, E9, E9(R1), E10, E17) and FDA/EMA statistical guidance documents throughout the clinical development lifecycle.
• Maintaincurrent knowledge of evolving regulatory expectations for rare disease programs, including implications of Orphan Drug and Breakthrough Therapy designations on study design and evidence standards. 

1. Data Analysis, Reporting & Integrity

• Oversee execution of all statistical analyses including interim analyses,primary/finalanalyses, safety reviews, and ad hoc requests, ensuring accuracy, reproducibility, and regulatory compliance. 
• Lead generation and review of Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory packages, working closely with statistical programming.
• Review and approve CDISC-compliant SDTM andADaMdataset specifications, define.xml documents, and reviewer's guides for regulatory submissions. 
• Oversee IDMC/DSMB activities including charter and SAP development, preparation of unblinded analyses, and coordination with independent statisticians.
• Ensure all statistical deliverables meet ICH E3 (CSR structure), CDISC, and applicable FDA/EMA technical standards.

1. Cross-Functional Collaboration

• Partner with Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Safety, and Medical Writing to embed statistical rigor throughout the study lifecycle.
• Collaborate with Data Management on CRF design, data validation rules, database structures, andeCOA/ePRO platform specifications.
• Provide statistical input to publication strategies, scientific communications, and clinical evidence planning in partnership with Medical Affairs.

1. Vendor & CRO Oversight

• Serve as Vor's statistical representative in the selection, qualification, and oversight of CROs, statistical programming vendors, IRT providers, andeCOAplatforms. 
• Review and approve vendor-generated statistical deliverables for scientific quality, compliance, and timeliness; escalate and resolve issues proactively to protect program timelines and data integrity.

1. Standards, Infrastructure & Innovation

• Contribute to the development and maintenance of Vor's internal biostatistical standards, SOPs, templates (SAP, DMC charter, analysis specifications), and best practices.
• Champion adoption of modern statistical methods including Bayesian analysis, real-world data integration, model-based drug development, and simulation-based sample size approaches.
• Stay current with regulatory guidance, methodological advances, and industry benchmarks to continuously elevate Vor's statistical capabilities.

1. Leadership & Talent Development

• Provide mentorship and technical guidance to junior biostatisticians and cross-functional data scientists within the Biometrics organization.
• Contribute to workforce planning including defining resourcing needs and supporting recruitment and development of talent as Vor's pipeline expands.
• Foster a culture of scientific rigor, continuous learning, and collaborative excellence.

Qualifications 

Education 

• PhD in Biostatistics, Statistics, or a closely related quantitative discipline strongly preferred.
• Master's degree (MS/MA) in Biostatistics or Statistics with extensive industry experience may be considered.

Required Experience 

• Minimum 10 years of pharmaceutical/biotech industry experience in clinical biostatistics, with at least 5 yearsina senior or program-lead capacity. 
• Demonstratedprogram-level statistical ownership from protocol design through regulatory submission (IND, NDA/BLA, or MAA). 
• Hands-on experience with adaptive designs, Bayesian methods, or novelestimandframeworks (ICH E9(R1)). 
• Track record of direct FDA and/or EMA interaction, including preparation and response to agency queries.
• Experience managing CRO statistical and programming relationships and vendor deliverable quality.
• Proficiencyin SAS (required); R strongly preferred; Python or additional statistical languages a plus. 
• Familiarity with CDISC standards (SDTM,ADaM), eCTD submission requirements, and reviewer's guide preparation.

• Prior experience at a clinical-stage biotech with responsibility for building or scaling a biometrics function. 

Preferred Experience 

* Experience in rare disease or immunology drug development.  

• Experience with small-sample trial design methodologies (e.g., single-arm studies, external control arms,historical data integration).

Skills & Competencies 

• Demonstratedability to communicate complex statistical concepts clearly and concisely to diverse audiences — including clinical, regulatory, and executive stakeholders — through both compelling written deliverables and confident oral presentations. 
• Exceptional statistical reasoning with ability to translate complexmethodologyinto clear language for non-statistical audiences. 
• Strong leadership and cross-functional influence without requiring direct line authority over all stakeholders.
• Comfortoperatingin a lean, fast-paced biotech with hands-on execution alongside strategic thinking. 
• Ability to build statistical processes, standards, and infrastructure from theground up.
• Excellent written and oral communication; effective across regulatory, executive, and scientific forums.
• Strong project management skills; able to manage multiple programs simultaneously under tight timelines.
• Collaborative, patient-centered mindset aligned with Vor's mission in hematologic disease.

The salary range for the Director, Biostatistics is expected to be between $230,000 and $250,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

Here at Ginkgo, we are aiming to modernize ADME by bringing our experience in high-throughput screening to the in vitro small molecule drug pipeline. We are re-imagining ADME at scale, and we are seeking a visionary and technically adept High-Throughput ADME Scientist to help us build and execute this next-generation platform. This role is critical in accelerating our drug discovery pipeline by providing timely and high-quality in vitro ADME (Absorption, Distribution, Metabolism, and Excretion) data to guide lead optimization.

The ideal candidate will possess deep technical expertise in developing, validating, and implementing a variety of high-throughput ADME assays.

Key Responsibilities

Assay Development & Implementation

• Design, develop, optimize, and validate a wide array of high-throughput in vitro ADME assays (e.g., solubility, MDCK permeability, plasma protein binding, microsomal stability, hepatocyte stability, and CYP inhibition/induction).
• Automation and Screening: Experience working with automated liquid handlers such as Hamilton, Lynx, Bravo, and Formulatrix.

Data Analysis & Reporting

• Develop and perform mass spectrometry (LC-MS/MS, acoustic ejection mass spectrometry, or similar) analysis of samples from ADME assays. Responsibilities will include method development and troubleshooting.
• Ensure proper sample preparation and management for high-throughput analysis.
• Analyze, interpret, and report complex ADME data, including calculating key pharmacokinetic parameters.
• Present results and provide expert recommendations to medicinal chemists and project teams to inform go/no-go decisions.

Quality & Compliance

• Maintain detailed and accurate laboratory records, SOPs, and electronic notebooks.
• Ensure all laboratory activities comply with internal quality standards and safety regulations.

Minimum Qualifications

• Education: Ph.D. in Pharmaceutical Sciences, Pharmacology, Analytical Chemistry, or a related field with 2+ years of relevant industry experience, or a Master's degree with 5+ years of industry experience.
• Technical Expertise:
  • Extensive, hands-on experience with LC-MS or acoustic MS particularly in a high-throughput setting.
  • Proven track record in developing and running automated in vitro ADME assays using state-of-the-art laboratory automation.
  • Strong theoretical and practical knowledge of drug metabolism pathways and DMPK.
  • Familiarity with common ADME prediction software and data visualization tools.

 Preferred Skills

• Experience using lab automation.
• Programmatic coding experience (e.g., Python, R, or similar).
• Data visualization (Spotfire, Python, R, or similar).
• Experience handling clinical samples.
• Familiarity with working in a CRO (Contract Research Organization) environment or managing CRO relationships.
• Proficiency with electronic laboratory data capture systems (e.g., LIMS, ELN).

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.

Seaport Therapeutics is seeking a talented and experienced Program Leader (PL) to be an integrative cross-functional leader who is responsible for driving the GlyphAllo Program in order to maximize its future clinical and commercial success in the treatment of depression. This is a highly visible leadership role that bridges scientific, clinical, operational, and commercial disciplines. The GlyphAllo program is currently enrolling a Phase 2b study and the PL will lead the program to execute the current plans within timelines/budget and to plan for future pivotal clinical studies, initial global regulatory filings and pre-commercial activities. He/she will provide leadership across the spectrum of drug development and pre-commercialization activities, ensuring achievement of program and corporate goals. The ideal candidate will be a strategic and entrepreneurial leader well-versed in drug development and commercialization, and a strong influencer who can integrate multiple perspectives effectively and align stakeholders across different functions and levels of the organization.

This position requires a presence in the Seaport area of Boston, with a strong preference for being onsite 4 days per week to foster collaboration and effective leadership as the GlyphAllo program grows in complexity and importance. 

Summary of Key Responsibilities

· Serve as the overall program lead, accountable for end-to-end planning, execution, and delivery of key milestones of clinical studies through NDA submission.

· Work collaboratively and cross-functionally with Research, Nonclinical Development, Clinical Operations, Clinical Research, Regulatory Affairs, Medical Affairs, Manufacturing, Quality Assurance, Drug Safety & Pharmacovigilance, Program Management, Distribution & Supply, Commercial and Finance to deliver on program goals within established timelines and budget.

· Partner closely with Program Management to drive alignment and execution across the cross-functional program team, including development and maintenance of integrated, cross-functional strategic plans, timelines, and budgets; proactive identification of risks; and implementation of mitigation strategies.

· Oversee the development of market research plans to gather deep insights from patients, providers, payers, and other stakeholders. Integrate the insights and other market competitive intelligence into program strategies.

· Integrate cross-functional perspectives, ensuring that program strategy is informed by scientific evidence, clinical data, and the evolving competitive landscape. On an ongoing basis, proactively anticipate issues and ensure contingency plans are put in place; identify barriers and identify solutions to mitigate them; identify opportunities and strategies to capitalize on them.

· Working with functional leaders, ensure that appropriate prioritization and adequate resource allocation (financial and personnel) are present to meet the program timelines and deliverables.

· Maintain a high performing cross-functional program team, monitoring program resourcing, managing conflict, and building team culture; create a positive atmosphere to get the most out of the team.

· Serve as an internal and external ambassador for the program, fostering broad engagement to cultivate strategic KOL relationships and enabling overall integration of external insights to inform program strategies.

· Summarize and represent the program to Seaport leadership, Board of Directors, collaborators, and other external parties, as requested.

Qualifications

· BA/BS degree required; advanced medical, scientific or business degree strongly preferred.

· 10+ years biopharmaceutical development and commercialization experience, with previous demonstrated program leadership responsibilities; demonstrated experience leading cross-functional teams in drug development and pre-commercialization.

· Deep understanding of drug development and global product registration is required, ideally in neuropsychiatry (with preference for experience in depression or anxiety). Commercialization and /or Medical Affairs experience considered a strong plus. Leadership of a recent successful program (positive pivotal data, regulatory approval, etc.) would be ideal.

· Proactive “hands-on” individual with collaborative orientation, who manages teams effectively, is very self-motivated and can smoothly establish strong working relationships within both internal and external organizations. Entrepreneurial problem solver. Achieves goals within timelines and budgets while anticipating and navigating obstacles effectively.

· Initiative and independence to identify short and long-term program needs, creatively formulate plans with team input, efficiently achieve timely decisions/alignment, and organize and deploy resources.

· Exceptional written and verbal communication skills; able to articulate program vision and motivate the team; communicates in an open, direct and timely manner; ensures broader organization is aligned with and aware of the program strategy, status and risks.

· Motivated by patient focus and personal commitment to high performance and results.

· Possesses high integrity and exceptional work ethic.

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $275,000-$310,000 with the final offer based on experience, market data, and internal equity.

We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established multiple programmable mRNA platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a Phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking to build a team that understands the value of working at a start-up.  Joining Strand now places you alongside the founding executive team and world-leading advisors. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team.  This opportunity will offer the employee the ability to work closely with the founding team and be a part of the growth strategy of the company.

We are looking for a highly motivated and enthusiastic leader for the role of Vice President of Clinical Development Operations. Reporting to the Chief Medical Officer, the Vice President of Clinical Development Operations will lead all clinical trial activities and operations for the organization. This individual will drive all trial activities for our 2 clinical stage programs as well as support the planning and development of other company programs as they advance throughout pre-clinical development into first-in-human clinical trials. This will also be an opportunity to work closely with various cross functional teams internally and externally to prepare for regulatory interactions and drive the development of our programs forward. 

Primary Responsibilities:

• Serve as the clinical operations expert for all clinical stage and preclinical stage programs for the company. 
• Accountable for delivery of assigned clinical program/trial budgets, managing study timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
• Develop clinical timelines, budget forecasts and ensure accountability for tracking and deliverables.
• Develop and maintain departmental resource and budget plans.
• Ensures oversight and study-specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path), ensuring appropriate escalation when required. Evaluate study-level issues for broader impact (e.g., cross-study, cross-program etc.) and ensure resolution
• Partner and collaborate with cross-functional stakeholders, external consultants, and other relevant stakeholders
• Lead and oversee execution of clinical trials in compliance with ICH/GCP, local regulations, and Strand Therapeutics’ SOPs to ensure quality and data integrity
• Support the selection, oversight, and management of CROs and other vendors including financial aspects of the partnerships.
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team.
• Develops site recruitment, enrollment, and engagement strategies for all clinical trials
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Manage and provide oversight to the cross functional teams and CRO/vendor(s) related to all aspects of clinical trial operations
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures. Manages content, agenda, and discussions at clinical operations sub-teams and ensures action items are closed
• Along with other Clinical Development personnel, represent Strand Therapeutics externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost, and issues to ensure timely decision-making by senior management
• Oversee/collaborate with Clinical Quality Assurance on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Strand Therapeutics
• Provide oversight and mentorship to assigned Clinical Operations staff by providing clinical operations/functional area expertise and support identification and prioritization of study and program level work. Will have direct line management of Clinical Operations staff.
• Strive for continuous improvement and more efficient ways of working in clinical operations
• Supervise Clinical Operations Team (CTMs, CRAs, CTAs, etc.) and ensure team member’s adherence to the regulatory requirements, ICH-GCP guidelines, and other relevant procedures.
• Participate in the design, development and review of clinical trial protocols and study-specific documents, e.g., informed consent forms, study guidelines, operations manuals, oversight plans, process developments (including Trial RACI).
• Keep up to date with industry practice and communicate key messages back to Strand Therapeutics, providing recommendation accordingly.

Qualifications:

• 15+ years of clinical trial operations experience in biotech; Experience working in a smaller, fast paced environment highly preferred with 5+ in management or leadership roles.
• Experience running oncology trials required.
• Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations and regulatory components is essential.
• Experience with all aspects of clinical trial management including streamlining operational activities of trial protocols and ensuring deliverables are attained in a timely manner. 
• Proven success participating in cross-departmental clinical strategy, planning and implementation activities. (Departments include executive leadership, regulatory, QA, CMC, translational development, program management, finance, business development, medical affairs and medical writing).
• Extensive experience with the identification, negotiation, management, and oversight of external vendor partnerships, such as CROs, for monitoring, database management, statistics, and safety reporting. 
• Experience building an internal clinical program management function, managing a team of employees and consultants as well as hiring internal stakeholders to support trial needs and leveraging external consultants as needed. 
• Experience with regulatory submissions, including INDs, NDAs and BLAs highly preferred. 
• Experience interacting with domestic health authorities, such as the FDA, required; Experience interacting with global regulatory health authorities, such as the EMA, PMDA, and/or Australian CTN is a plus. 
• Strong interpersonal skills with the ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization. 
• Strong organizational and time management skills. 

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $316,000 - $356,000 annually plus bonus and equity incentives 

Summary/Primary Role:

This role will be assisting with the drilling operations for geothermal energy projects. You will work closely with the Lead Driller and other team members to ensure the smooth and safe operation of the drilling equipment, perform routine maintenance, and contribute to the overall success of our geothermal drilling efforts.

Principal Duties & Responsibilities:

(Management may amend or assign duties and responsibilities to this job at any time)

• Assist the Lead Driller in daily drilling operations, including setting up and operating drilling equipment.
• Monitor and maintain equipment during the drilling process, ensuring it is functioning properly and troubleshooting when necessary.
• 100% travel required in the greater Northeast Region of the United States - CT, MA, NY, ME, VT, NH, NJ, MD
• Handle and prepare drilling tools, pipes, and other equipment for use during operations.
• Transport equipment and materials to and from the drill site as needed.
• Follow safety protocols and ensure the worksite is organized and compliant with health and safety regulations.
• Assist in the operation of mud systems, pressure control equipment, and other drilling-related systems.
• Keep accurate records of daily drilling activities, including work progress, downtime, and equipment performance.
• Support the team with general labor tasks, such as setting up rig structures, managing materials, and maintaining a clean and safe work environment.
• Perform routine maintenance and inspections on tools and equipment.
• Ensure that the proper safety and environmental standards are met during all phases of drilling operations.
• Communicate effectively with the drilling team and report any issues or concerns to the supervisor promptly.
• All other duties and projects assigned.

Qualifications:

• High School Diploma required.
• Active CDL strongly preferred.
• High School Diploma or GED required.
• OSHA 30; SST card and Flagger certification strongly preferred.
• Prior experience operating drilling equipment is a must.
• Understands and follow utility locate law and compliance procedures, safety protocols, instructions, and quality regulations.
• 5+ years of construction and/or drilling experience (either NY, NJ, CT, MA Master Drilling license a plus); NGWA certification preferred.
• Experience with geothermal heat pumps.

Supervisory Responsibility: 

This position has supervisory responsibility.

Expected Hours of Work: 

An Employee must work a minimum of thirty (30) hours each week to maintain full-time status for benefits purposes, however the expectations of the position will require an average of forty (40) hours with overtime required as scheduled.  The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining an employee’s base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, years of relevant experience, education, credentials, and internal equity). Brightcore also offers a comprehensive set of benefits to compliment the salary. The hourly hiring range for this position is $37.00-$42.00 and there is eligibility for overtime for all hours worked over 40 hours per week.

Travel Requirements:  

• Travel required 100% in the greater Northeast Region of the United States - CT, MA, NY, ME, VT, NH, NJ
• Must be willing to be away from home Monday through Friday & scheduled Saturdays.
• Lodging will be provided for overnight stays.

Work Environment:

• Work site setting. 

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

• This is a safety sensitive position.