Seeking talent near: Princeton, NJ

Position Summary

The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from clinical development to process validation and life cycle management. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. The role will be critical in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.

Primary Responsibilities

• Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials.
• Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
• Other responsibilities as assigned.

Education and Experience

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.
• A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.
• Demonstrated success in the field of formulations and dosage form development.  
• Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the dosage form formulation and package development, manufacturing process development, scale-up, optimization and validation processes.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

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ESSENTIAL JOB FUNCTIONS:

The Senior Director, Medical & Regulatory Writing serves as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books. May also provide guidance on document strategy for more complex dossiers for regulatory submission such as IND and NDA/BLA filings. This role leads and is accountable for the Medical Writing and Clinical Trial Transparency & Disclosure functions. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. The qualified candidate will also have experience in management of external vendors and the development of operational process improvements such as work practice documents, SOP development and updates, and document templates. There will need to be a very strong understanding of document timelines as planning is critical.

• Provides leadership, strategy, and oversight of the Medical & Regulatory Writing team.
• Serves as subject matter expert in preparing clinical regulatory documents through all phases clinical research.
• Represent medical writing in cross-functional team meetings.
• Collaborate with department heads and staff members of cross-functional groups, including clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary to deliver documents with high quality on time.
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement and maintenance of medical writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.
• Oversight of vendors including contract writers, QC reviewers, and document formatters.
• Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents.
• Maintain current knowledge of industry trends and best practices for medical writing
• Performs other duties as assigned

JOB SPECIFICATIONS:

• Bachelor’s, Master’s or PhD Degree in scientific, medical, clinical discipline or related field is required. Masters or Ph.D. degree is preferred.
• Strong track record of people management and delegating work.
• 12+ years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred.
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochure. Experience authoring and managing briefing books is a plus.
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Project management skills as related to medical writing.
• Ability to manage complex writing projects with minimal supervision.
• Must have the ability to edit text for brevity and clarity.
• Ability to understand, interpret and present complex clinical data.
• Must be highly detail oriented.
• Ability to coordinate multiple documents while effectively managing timelines.
• High degree of independence in decision making and problem solving.
• Leads decision-making across multiple programs or areas, setting direction and making strategic trade-offs that impact cross-functional execution and outcomes.
• Drives cross-functional alignment across multiple programs, influencing stakeholders to shape strategy and ensure cohesive execution across functions.
• Understanding of FDA and ICH regulations and guidelines.
• Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools.
• Must be an expert with MS Word and have a solid working knowledge of MS Excel, MS PowerPoint, and MS Project.
• Experience in use of an EDMS such as Documentum, Core Dossier, or Veeva.

The base range for this role at the Senior Director level is $265,000 - $306,000 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.

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Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director will collaborate with the Clinical Data Management team by providing leadership and knowledge.  Assists the head of Data Management in directing the design, documentation, testing and implementation of clinical data collection studies, and clinical database reviews in support of company objectives.  Ensures that the data management systems are business ready and of appropriate quality to fulfill those objectives.  Focuses on the oversight of quality data deliverables within Acadia Data Management and projects with Contract Research Organizations (CROs).

Primary Responsibilities

• Participates in the collaboration and coordination with others to design and implement clinical protocols and data collection systems.
• Assists in identifying and resolving data management issues on assigned studies.
• Responsible for ensuring data management timelines are met within assigned studies, in-house or outsourced.
• Provides strategic input into protocol design focused on data management portions.
• May assist Biostatistics in development/review of Statistical Analysis Plans.
• Reviews and resolves data discrepancies for standardized data validation systems and procedures, when applicable.
• Supports data management requirements and deliverables for New Drug Application (NDA)/Marketing Authorisation Application (MAA), including integrated databases. 
• Aids in production of quality data deliverables to support regulatory submissions, publications and due diligence activities.
• Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality.
• Oversees projects that have been engaged with CROs, as well leads and manages internal projects.
• Oversees and manages final data management electronic Trial Master File (eTMF) for assigned studies.
• Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
• Assures compliance with industry quality standards, guidelines and procedures.
• Assists in the selection and evaluation of new personnel to ensure the efficient operation of the function.
• May assist in the career development of Data Management personnel.  Position may have direct reports. May assist with input into corporate and department budget process and management.
• Other responsibilities as assigned.

Education and Experience

• Bachelor’s degree in Life Sciences, Mathematics or related field.  Targeting 8 years of progressively responsible experience within the pharmaceutical, biotech or CRO industry.  An equivalent combination of relevant education and experience may be considered.
• Previous experience in data management from protocol concept through database lock and clinical study report finalization.
• Knowledge of medical terminology.
• Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
• Excellent verbal and written communication skills as well as interpersonal and organizational skills
• Proficiency in MS Office applications.
• Proficiency with data management systems and supporting statistical programs (e.g., SAS),
• Knowledge of database design and database concepts.
• Skilled at cross-functional/department communications to gain cooperation of others.
• Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Must be able and willing to travel on occasion.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-SL1

Please note that this position can be based in Princeton, NJ, OR San Diego, CA, OR San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

This role is responsible for supporting Clinical Operations’ management objectives to perform clinical trials that are of high quality, and that are delivered to agreed timelines and budget. This role manages clinical operations processes including project planning, budget, resource management, and contract research organization management. This role serves as a key contact and resource for Clinical Study Managers, CRA’s and Clinical Trial Assistants. Responsible for ensuring that clinical studies are carried out and delivered according to GCP and company SOPs. Assists with the creation and implementation of policies. Works cross-functionally to ensure that the teams provide required inputs and receive updates to carry out clinical trials in an effective manner.

Primary Responsibilities

· Manages clinical operations teams and represents clinical operations on multi-function projects teams, internally/externally. Works with clinical investigators, other roles, and Clinical Service Providers (CSP) to develop, execute, and deliver clinical studies/programs that are of high quality.

· Ensures quality delivery of study enrollment within agreed budgets and timelines.

· Participates in the design/review of clinical protocols, case report forms, tools and tracking systems, and IXRS systems.

· Develops and manages relationships with critical and non-critical 3rd party vendors and clinical site staff; maintains ongoing documentation, performs risk analyses, and may participate in due diligence and audit reviews.

· Effectively communicates project status and issues to management and the team.

· Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)) etc.

· Manages and reviews the work of Contract Research Organization (CRO) to ensure that tasks are performed to scope and budget.

· Liaises with other functional groups to ensure that timelines, budgets, and study objectives are met.

· Liaises closely with Clinical GCP group to ensure that quality metrics are met throughout a trial.

· Oversees clinical study budgets.

· Provides day-to-day direction to Study Managers and Clinical Trial Assistants to carry out their work.

· Ensures compliance with good clinical practices (GCP), good documentation practices (GDP), and regulatory guidelines.

· Recommends and implements innovative process ideas to positively impact clinical trials management.

· Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in life sciences or related field. Targeting 8 years’ progressively responsible pharmaceutical experience with a focus on clinical trials and late phase development. Leadership experience and CNS therapeutic experience preferred. An equivalent combination of relevant education and applicable job experience may be considered.

Key Skills:

· Knowledge and understanding of Good Clinical Practices (GCP) and other Clinical Trials Regulations and guidelines.

· Experience developing clinical protocols, Standard Operation Procedures (SOP), Clinical Study Reports, and other documents to support New Drug Application (NDA).

· Demonstrated ability to successfully develop, implement, and manage clinical trials.

· Practical experience in clinical trial strategies, methods, and processes; knowledge of clinical trial design.

· Demonstrated technical, administrative, and project management capabilities.

· Strong interpersonal, organizational, and workload planning skills, along with excellent verbal and written communication skills.

· Proficient computer skills, including Microsoft Word and Excel.

· Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the department or segments of the organization.

· Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.

· Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.

· Must be willing and able to travel both domestically and internationally.

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Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director in the Early Stage Drug Product Development organization at Acadia is responsible for the development of pharmaceutical formulations primarily intended for early-stage clinical trials and preclinical animal studies. This role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent will focus on formulation strategies tailored to early development phases, ensuring that candidates are suitably prepared for initial safety and efficacy evaluations. Additionally, collaboration with research scientists and external partners is essential to address technical challenges and advance promising compounds toward clinical readiness.

The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues The role will be critical in ensuring that we select developable drug candidates, reduce risk and accelerate the introduction of new chemical entities into the Acadia pipeline.

Primary Responsibilities
 

• Designs and develops pharmaceutical formulations to support early stage clinical trials, providing acceleration options such as on-site compounding and impromptu type of drug products.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, oversee operations at existing suppliers.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• With Translational Sciences teams, plans conduct of preclinical and toxicological studies and develops requisite formulations for the same considering developability of the new drug candidates.
• Develops phase appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies employing resource sparing approaches such as compounded formulations and/or on-site preparations.
• Conduct physicochemical characterizations of the new drug candidates to support developability assessments.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with the CMC team, late-stage formulation team, and formulation development management to establish the development strategy for formulation of the new drug candidates.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Collaborates with regulatory teams in preparation of the health authority submissions for the early clinical trial applications (e.g. IND, CTA, IMPD)
• Other responsibilities as assigned.

Education/Experience/Skills

Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.  A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.  Demonstrated success in the field of formulations and dosage form development.   Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the physicochemical characterization of new drug candidates to assess developability, formulations for early stage clinical studies, and dosage form formulation and package development.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel to domestic and international locations is required.

#LI-HYBRID #NC1 

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director, Trial Master File (TMF) Oversight & Inspection Readiness (IR) is responsible for leading the operational oversight of the TMF and supporting the framework that ensures Trial Master File integrity, sustained inspection readiness, and regulatory compliance within Clinical Operations.  This role leads TMF health governance, inspection preparedness, and risk identification processes to safeguard the organization during regulatory inspections and audits.  The Associate Director serves as the Clinical Operations lead for inspection defense, by advancing consistent standards, proactive risk visibility, and clear organizational insight into TMF integrity and inspection readiness.

Primary Responsibilities

TMF Oversight & Governance

• Establish TMF health oversight framework across studies, ensuring compliance with GCP and industry standards.

• Monitor TMF quality metrics across programs, ensuring completeness, timeliness, and accuracy of essential documents; Escalate any TMF metrics falling outside of KPIs to appropriate stakeholders for resolution and corrective action.

• Lead and share TMF best practices with internal and external stakeholders, as appropriate. Oversee TMF risk trending and remediation plans.

• Maintain inspection-readiness standards for documentation.

Inspection Readiness Leadership

• Develop and maintain a sustainable inspection readiness model, including development and maintenance of comprehensive inspection readiness tools, reference materials and coordinating training guidance to staff on preparation efforts for health authority inspections.

• Lead inspection storyboarding and narrative development. Coordinate inspection preparation activities. Lead designated Clinical Operations activities during regulatory inspections.

• Support post-inspection CAPA alignment, in partnership with Quality.

• Support Clinical Operations team on all inspection commitments, responses, post-inspection activities and implementation of corrective and preventative actions; provide lessons learned from mock and actual inspections. Ensure portfolio-level visibility of inspection risk.

Other Responsibilities

• Partner cross-functionally to align on audit and inspection strategy, as well as TMF platform integrity. Align with functional study teams on TMF accountability expectations. Maintain awareness of industry trends and developments to help define the future strategic direction for TMF and Inspection Readiness.

• Other responsibilities as required.

Education/Experience/Skills

Bachelor’s degree in life sciences or related field; Advanced degree preferred.  Targeting at least 8 years pharmaceutical industry and/or clinical research organization experience, with at least 5 years TMF experience in a leadership role.  Health Authority inspection and eTMF experience is required. An equivalent combination of relevant education and experience may be considered.

Key Skills

• Thorough understanding of GCP and ICH guidelines; thorough understanding of the drug development process.

• Knowledge and understanding of the current regulatory requirements (e.g., FDA, EMA, MHRA) in a global environment.

• Thorough understanding of the CDISC TMF Reference model; direct experience with the TMF Reference Model working group is preferred.

• Veeva Vault eTMF/CTMS experience preferred.

• Ability to lead, motivate, and influence others, including prior leadership experience, is strongly preferred.

• Adept at creating and communicating a clear vision among, effectively aligning resources and motivating stakeholders to achieve goals.

• Demonstrated analytical abilities and proficient planning and negotiation skills. Demonstrated technical, administrative and project management capabilities. 

• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.

• Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output. Demonstrated problem-solving abilities, with strong attention to detail. 

• Able and willing to travel both domestically and internationally.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

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Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director, Vendor & Relationship Management will support and optimize strategic partnerships with clinical vendors, CROs, and functional service providers to ensure operational excellence, compliance, and value delivery across global clinical development programs. This role will drive vendor governance, performance management, and continuous improvement initiatives while collaborating cross functionally to support R&D business objectives and foster a culture of partnership and innovation.  The Associate Director will partner closely with R&D stakeholders, Procurement, Quality, Finance, and Legal to enable effective vendor oversight and consistent outsourcing practices across the Acadia R&D organization.

Primary Responsibilities

Vendor & Relationship Management

• Support the development and execution of vendor and supplier relationship management strategies, including identification and management of critical partners (CROs, central and specialty labs, functional service providers, clinical technologies, patient recruitment and retention vendors).

• Serve as a primary point of contact for vendor related operational issues, coordinating resolution and escalating unresolved matters through established governance pathways.

• Coordinate and facilitate, when appropriate, vendor governance, including operational and steering committee meetings.

• Develop and maintain supplier scorecards, dashboards, and KPIs to monitor vendor performance and identify trends and risks.

• Conduct routine business reviews with vendors to ensure alignment on priorities and performance expectations, partnering with Sourcing and Legal as needed.

Operational Oversight & Excellence

• Oversee vendor performance supporting outsourced clinical trials, through partnership with the Clinica Operations team. Ensure alignment with program timelines, budgets, and quality expectations.

• Partner with Clinical Operations, Clinical Supply Chain, Quality, Finance, and other cross functional teams to support timely and compliant delivery of services.

• Support inspection readiness activities, including audits, vendor oversight documentation, and CAPA development in collaboration with Quality.

• Contribute to process mapping, documentation, and implementation of standardized vendor oversight practices.

Innovation & Continuous Improvement

• Identify opportunities to improve vendor performance, efficiency, and collaboration through data driven insights and process improvements.

• Support innovation initiatives within vendor relationships, including new operating models, technologies, or ways of working.

• Contribute to the development and rollout of best practices, standards, and tools for R&D vendor management.

• Identify opportunities for cost optimization, demand management, and improved vendor utilization.

Data, Reporting & Technology Enablement

• Support the development and maintenance of vendor performance reporting and dashboards.

• Analyze performance metrics to proactively identify risks, issues, and opportunities for improvement.

• Partner with internal teams to support implementation and optimization of vendor management tools and systems.

• Act as a mentor and subject matter resource for team members and matrixed stakeholders involved in vendor oversight.

• Foster strong, collaborative relationships with internal stakeholders and external partners to enable transparent communication and proactive issue resolution.

• Effectively influence stakeholders across a matrixed organization without direct authority.

• Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in life science or a related field; Advanced degree preferred.  Targeting 8 years of experience in clinical trial operations, vendor/CRO oversight, supplier relationship management, or related roles within the biopharmaceutical industry.  Experience managing complex vendor relationships and supporting performance improvement initiatives required.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Strong understanding of clinical trial operations and outsourced service models.

• Working knowledge of ICH GCP, regulatory requirements, and quality expectations for outsourced clinical activities.

• Strong analytical skills, including experience with supplier scorecards, KPIs, and performance dashboards.

• Experience in R&D outsourcing, vendor governance, or business operations functions.

• Exposure to financial management of outsourced services, including budgeting and accruals.

• Experience supporting audits, inspections, or inspection readiness activities.

• Familiarity with alliance or partnership management methodologies.

• Excellent communication, interpersonal, and organizational skills.

• Ability to work effectively in a fast paced, matrixed environment while managing multiple priorities and working cross-functionally.

• Willing and able to travel both domestically and internationally.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HBRID #NC1

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director of Drug Safety & Pharmacovigilance is a medical safety expert within the Drug Safety & Pharmacovigilance (PV) function, reporting to the Executive Director of Medical Safety. This role serves as the primary medical safety resource for assigned products across the Acadia portfolio, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical oversight of pharmacovigilance activities throughout the product lifecycle. The Director contributes product-level medical input to cross-functional safety governance, collaborates with the Executive Director of Medical Safety on complex or escalated safety issues, and supports regulatory submissions and health authority interactions for assigned products. 

Primary Responsibilities

• Serves as the primary medical safety resource for assigned Acadia products, providing product-level clinical safety and pharmacovigilance expertise across all stages of development and post-marketing surveillance
• Performs medical evaluation and interpretation of aggregate safety data for assigned products, including signal detection and evaluation, ad hoc safety assessments, and benefit-risk analyses; escalates complex or novel safety issues appropriately
• Assesses safety signals and trends for assigned products and proactively manages potential safety issues in collaboration with cross-functional stakeholders
• Contributes product-level medical input to the Medical Safety team and other cross-functional safety governance bodies
• Performs medical review of all serious adverse events from Acadia clinical trials for assigned products
• Performs retrospective medical review of adverse events for post-marketed products
• Authors Analysis of Similar Events (AOSE) and individual case narratives and comments for ICSRs for assigned products
• Provides oversight for the safety aspects of clinical studies for assigned products, including development and maintenance of product-specific core safety information
• Reviews and approves safety sections of clinical documents for assigned products, including protocols, DSURs, final study reports, and other documents as required
• Formulates response strategies and authors health authority responses for safety-related queries pertaining to assigned products, in collaboration with the Head of Medical Safety
• Provides medical input into Periodic Benefit Risk Evaluation Reports (PBRERs) for assigned products, including clinical interpretation of safety data
• Provides medical and scientific input into Risk Management Plans (RMPs/dRMPs) and REMS programs for assigned products
• Ensures all PV Medical Safety activities for assigned products are performed in compliance with applicable regulations and Acadia standards
• Maintains current knowledge of global regulatory authority regulations and guidance
• Other responsibilities as assigned

Education/Experience/Skills

• MD (Doctor of Medicine) or equivalent medical degree from an accredited institution, with relevant postgraduate clinical training and experience; candidates who are eligible for U.S. medical board certification are preferred. MPH or pharmacoepidemiology training is a plus. 
• 6 to 7 years of relevant drug safety experience, including expertise in safety signal management (signal detection, evaluation, aggregate data review, ICSRs), preferably in a pharmaceutical or biotech environment.  
• Neurology, psychiatry, rare disease, or CNS-related therapeutic area experience strongly preferred
• Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, including clinical trial safety monitoring, post-marketing surveillance, ICSR processing, aggregate reporting, and health authority reporting requirements
• Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data
• Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
• Ability to author and critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
• Strong analytical and critical decision-making skills; ability to manage competing priorities and meet deadlines with minimal oversight
• Experience with pharmacovigilance safety databases (Argus) and signal detection tools
• Familiarity with pharmacoepidemiology concepts and study design
• Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders
• Proficiency in MS Office Suite (Word, PowerPoint, Excel)
• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment
• Must be willing and able to travel both domestically and internationally

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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Key Duties and Responsibilities 

Collaborate with global clinical teams (Clinical Operations, CMC, Quality Assurance, Regulatory, etc.) and network of Clinical Development and Manufacturing Organizations to oversee end-to-end supply chain activities from phase 1-3 and IIT trials. Leads and manages clinical packaging and labeling operations / Investigational Drug, Standard of Care Drug and Medical Devices, drive clinical label creation and approvals process, including translations for applicable countries. Lead end-to-end supply chain network set-up for new and upcoming global clinical trials. Develop Supply Strategies and Inventory optimization plans per program, protocol design and region. Design, Implementation and UAT of Interactive Response Technology (IRT/IxRS) for multi-arm drug-device combination trials. Develop, implement, and update Supply Chain SOPs and Work Instructions. Co-develop device and pharmacy manual. Manage Temperature excursions, CAPA, SCARs and other quality events as applicable. Supplier Management: Standard of Care Drug Procurement, RFQ, Vendor Management, Cost saving initiatives, Negotiations, Supplier relationship/evaluation. Quarterly review of budgets vs actual spend for active studies. Provide Supply Chain support for regulatory filings including IND submission information, Import/Export Licenses filing and audits from all health agencies. Proactively report supply risk, product and material availability issues. Participate in and contribute to supply chain metrics, S&OP (Sales & Operations Planning) process. Drive Ad-hoc projects to review exceptions/changes relating to Supply Chain. This position is open to telecommuting from anywhere in California. Requires occasional presence in office. Travel required. As needed, up to 15% travel covering global  Supply Chain areas for Supply Chain Management, Clinical & Commercial Supply Chain, Manufacturing & Production Planning, and other related activities.

Requirements

Master’s degree or foreign equivalent in Supply Chain Management, Industrial, Operations, Production engineering or closely related degree and experience as an Associate Manager, Technical Operations & Supply Chain, Supply Chain Specialist, Clinical Supply Chain Coordinator or related occupation in supply chain management. APICS/ASCM Certification required (CPIM or CTL or CSCP).

Desired Education, Skills and Experience

Experience must include four (4) years of experience in all of the following:

1. Experience in global clinical supply chain management, medical device industry and developing/implementing clinical trial management technologies (eg: IxRS, IRT, etc.).
2. Experience in forecasting, supply planning, optimizing inventory, S&OP process, scenario planning, production planning & scheduling, CMO management, regulatory requirements relating to clinical labeling, packaging, and distribution activities.
3. Working under a highly regulated cGMP and GCP manufacturing environment.
4. Designing and setting up complex supply chain networks within strict FDA compliance, GLP, GCP and GDP frameworks.

Or an alternative Bachelor’s degree or foreign equivalent in Science in Supply Chain Management, Industrial, Operations, Production Engineering or a closely related degree and experience as an Associate Manager, Technical Operations & Supply Chain, Supply Chain Specialist, Clinical Supply Chain Coordinator or related occupation in supply chain management. APICS/ASCM Certification required (CPIM or CTL or CSCP).                                

Experience must include six (6) years of experience in all of the following:

1. Experience in global clinical supply chain management, medical device industry and developing/implementing clinical trial management technologies (eg: IxRS, IRT, etc.).
2. Experience in forecasting, supply planning, optimizing inventory, S&OP process, scenario planning, production planning & scheduling, CMO management, regulatory requirements relating to clinical labeling, packaging, and distribution activities.
3. Working under a highly regulated cGMP and GCP manufacturing environment.
4. Designing and setting up complex supply chain networks within strict FDA compliance, GLP, GCP and GDP frameworks.

Salary: $149,282.00 annually

Job Requisition #277

Opened: 08 APR 2026

The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the Heartflow Clinical Research staff and collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture.

Job Responsibilities:

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development
• Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
• Perform other duties as required for successfully completing studies, as necessary

Skills Needed:

• Ability to work in a smaller team environment with a willing, all hands on deck attitude
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required
• Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint

Educational Requirements & Work Experience:

• Bachelor’s degree in science or health related field
• Demonstrated 5 years minimum relevant experience required
• Experience in cardiovascular medical device clinical research a plus

Travel required: up to 25%

A reasonable estimate of the base salary compensation range is $110,000 to $150,000 (for San Francisco Bay Area) or $95,000 to $125,000 (for all other areas) and cash bonus. #LI-IB1

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.  

Position Summary

The Manager/Senior Manager of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan) are desirable.

Key Duties and Responsibilities

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities.

• Successfully lead global and cross-functional quality projects

• Maintains current knowledge of ever-changing clinical quality guidance and regulations.

• Excellent communication and people skills to ensure cohesive and collaborative teamwork. 

• Demonstrated ability to implement and collaboratively drive company initiatives and policies.

• Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred.

• Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close).

• Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions. 

• Establish Quality and Cross-Functional SOPs, processes and associated documents. 

• Working closely with clinical pharmacovigilance team on supporting clinical trial safety. 

• Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management. 

• Other duties as assigned. 

Desired Education, Skills and Experience

• B.S. Degree in life sciences with advanced degree in a scientific discipline preferred.
• Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance.
• Minimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as lead auditor experience preferred.
• Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents.
• Previous experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experience is a plus.
• Pharmacovigilance/Safety QA experience is a plus.
• Medical Device GCP experience is a plus.
• ISO Standard (e.g. ISO13485, ISO9001, ISO27001) understanding is a plus.
• Medical Device Reporting (MDR) – FDA 21 CFR Part 803.
• Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoring.
• Experiences with Clinical Quality Management on a risk-based approach is needed.
• Electronic TMF, document, quality, and learning management systems experience
• Strong organizational and project management skills.
• Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment.
• Professional working proficiency in English

REQUIREMENTS:

Physical Demands

• None, other than those necessary to perform the essential job functions

Manual Dexterity

• None, other than those necessary to perform the essential job functions

Audible/Visual Demands

• Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.

Environment

• None, other than those necessary to perform the essential job functions.

Travel

• Up to 30%

The expected salary range for this position based in California is $150,000 to $170,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

About the Role

The Medical Science Liaison (MSL) reports to our National Director of Field Medical. MSLs are field-based healthcare professionals to our customers. They will engage in compliant scientific exchange and provide whole practice education on disease state and respond to inquiries related to our products.

Let’s talk about some of the key responsibilities of the role:

• Manage key opinion leader (KOL) optometrists and ophthalmologists in a designated region, ensuring compliant conduct per PhRMA and Tarsus guidelines.
• Be the primary medical affairs KOL point of contact for day-to-day needs and peer-based scientific exchange, adhering to our Tarsus scientific platform; engagements may include both virtual and live interactions.
• Collect actionable insights from field scientific exchange, prioritize and collate these insights to shape medical strategy.
• Provide whole practice education to optometric and ophthalmic centers.
• Provide resources to facilitate disease state education in Optometry schools and Ophthalmology residency programs.
• Instruct customers (upon request) on investigator initiated trial and medical information procedures.
• Compliantly identify and recommend KOLs for a variety of projects (including advisory boards, medical education initiatives, training, publications, special projects, clinical trials, business development evaluations) based on expertise, interests, and competencies.
• Plan KOL engagements and schedule and attend scientific sessions at local, regional and national medical meetings as needed.
• Liaise with local and regional optometric and ophthalmic medical societies
• Present scientific evidence to the payer community.
• Provide leadership and expertise on medical affairs projects and initiatives.
• Participate in continual optimization of training, insights gathering and field medical processes.
• Host local disease state scientific exchanges and “lid+lash labs.”
• Participate in compliant and collaborative engagements with cross-functional team members including training and KOL meetings.
• Provide clinical trial support as needed and determine by the clinical development team.
• Manage territory budget, metrics, KOL mapping and CRM entries.

Factors to Success

• Doctorate of optometry, or MD, PharmD, PhD with eye care expertise required.
• 3+ years of experience as a medical science liaison in eye care is preferred; or 3+ years of clinical experience in eyecare with at least one year of industry experience or 7+ years of clinical practice in eyecare. Senior level exists for those with 4+ years of previous MSL experience.
• Strong emotional intelligence and presentation skills.
• Ability to plan, organize, manage, and prioritize workload proactively in a fast-paced environment.
• Ability to navigate systems and processes including Microsoft Office and customer relationship management software, work independently, and be self-motivated.
• Ability to collect actionable insights and critically analyze data.
• Ability to influence and collaborate with peers.
• Strong verbal and written communication skills to convey technical and clinical information.
• Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
• Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
• Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.

A Few Other Details Worth Mentioning:

• The position is field based and requires travel 60-80% of the time.
• Territory includes: Southern California, NV, and HI with candidates ideally located in: Los Angeles, Orange County, San Diego, or Las Vegas
• The candidates must live in their assigned territory, preference will be given to candidates who reside within 45 minutes of a major airport / major metropolitan area.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our National Director of Field Medical.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $134,200 to $188,000; with a higher range of $165,000 to $231,000 for candidates hired at the Senior level, plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Remote

What You Will Contribute To Altos

As part of our team, you will help to accelerate and optimize our progress in agentic AI methods for biological and clinical data curation and analysis.

In this role, you will be an integral part of our multidisciplinary teams building the computational platforms that will enable Altos to achieve its mission. You will collaborate with biomedical research experts as well as other machine learning scientists and engineers across the Institute of Computation to contribute to the Altos research and translation ecosystem, focusing on designing and building state-of-the-art agentic AI systems and workflows that tackle biological questions, accelerate clinical data analysis, and aid in the discovery of novel interventions for aging and disease.

The successful candidate will combine deep expertise in agentic AI methods with a strong foundation in bioinformatics and/or clinical R&D. You will work closely with domain experts to translate complex biological and clinical data challenges into intelligent, automated solutions. You will thrive in a fast-paced environment that stresses teamwork, transparency, scientific excellence, originality, and integrity.

Responsibilities

• Design and develop agentic AI workflows for biological and clinical data curation tasks
• Research and implement advanced context engineering techniques (RAG, agentic RAG, graph RAG) tailored to biomedical data
• Develop and optimize prompts and agent architectures for reliability, accuracy, and scientific rigor
• Build LLM-based tool-use systems and integrations relevant to bioinformatics and clinical R&D pipelines
• Collaborate with bioinformatics scientists, clinical researchers, and domain experts to identify automation opportunities and translate them into agentic solutions
• Evaluate and benchmark agentic systems, establishing rigorous metrics for performance and correctness in scientific contexts
• Stay current with the rapidly evolving landscape of agentic AI methods and contribute to internal best practices

Who You Are 

• Proven track record leveraging machine learning and AI to solve real-world problems
• Expertise in agentic AI methods development, including prompt optimization, LLM-based tool use, context engineering (RAG, agentic RAG, graph RAG), and agent evaluation
• Experience writing production-quality code with agentic frameworks (e.g., LangGraph, Pydantic-AI, DSPy, or similar)
• Deep familiarity with bioinformatics and/or clinical R&D, with the ability to engage meaningfully with domain experts on biological and clinical questions
• Proficiency with AI-assisted development tools (e.g., Claude Code, Cursor) to iterate rapidly
• A team player who thrives in collaborative environments and is committed to enabling colleagues to reach their full potential through giving and requesting feedback focused on professional growth
• Able to advise others across the wider function / company on cutting edge agentic AI practices and approaches to enable the science / research. Desire to constantly expand your skillset and knowledge. Keen to learn more about biology, machine learning, and medicine
• Inspired by the Altos mission of restoring cell health and resilience to reverse disease, injury, and age-related disabilities

Minimum Qualifications

• PhD in Computer Science, Machine Learning, Bioinformatics, or a related field
• Demonstrated experience developing agentic AI systems, including LLM-based tool use, prompt engineering, and context engineering techniques
• Strong foundation in machine learning principles and their application to real-world problems
• Strong background in bioinformatics, computational biology, or clinical R&D
• Familiarity with MCP server development and agent skill creation
• Very strong programming skills in Python, with experience writing production-quality, well-documented code
• Strong track record of published peer-reviewed research in AI/ML and/or computational biology

Preferred Qualifications

• Experience with AWS services (S3, Bedrock, Lambda) in the context of AI/ML workflows
• Experience with clinical trial data, regulatory data curation, or biomedical ontologies (e.g., CDISC, SNOMED, MedDRA)
• Track record working with NGS data (e.g., RNA-seq, ATAC-seq, DNA methylation) or other biological data modalities
• Experience designing evaluation frameworks and benchmarks for agentic AI systems
• Familiarity with knowledge graph construction and graph-based retrieval methods

The salary range for Redwood City:

• Senior Scientist I, Machine Learning: $257,400 - $330,000

The salary range for San Diego:

• Senior Scientist I, Machine Learning: $239,500 - $307,000

Exact compensation may vary based on skills, experience, and location.

#LI-NN1

For UK applicants, before submitting your application:

- Please click here to read the Altos Labs EU and UK Applicant Privacy Notice (bit.ly/eu_uk_privacy_notice)
- This Privacy Notice is not a contract, express or implied and it does not set terms or conditions of employment.

Position Summary

This position plays a critical role in strengthening and accelerating the global medical and scientific impact of Rakuten Medical’s Alluminox platform. Key responsibilities include designing and delivering training programs to external Health Care Professionals and internal teams in clinical development, operation and medical affairs/science functions. This role ensures that Alluminox technology is delivered to patient at the highest standard while gathering frontline feedback from medical society to enhance Rakuten Medical’s research, development and commercialization efforts.

Key Duties and Responsibilities 

• Design, organize, lead and execute training sessions for care professionals on product knowledge effectively
• Ensure patients globally in both clinical trial and commercial settings are treated at the highest standards and if necessary to provide onsite support
• Plan, organize, and execute Investigator Meetings, Advisory Board Meetings and other equivalent events and present on behalf of the company as needed
• Support research, development and commercialization efforts through collecting and synthesizing observation in the medical field and clinicians’ feedback
• Develop robust partnership relationship with HCPs within current and future therapeutic area
• Educating employees the insights and information gained from academic papers and conference
• Identify challenges for the mid to long-term global R&D and medical communication and propose/execute solutions from medical perspective.

Desired Education, Skills and Experience

• M.D. degree and surgeon experience required
• Specialty in otorhinolaryngology, gynecology or hepatology is a plus
• 10-year + Medical affair and / or R&D related experiences in healthcare industry required
• Demonstrated hands-on characteristics and proactiveness
• Focused on actions, problem-solving and result oriented
• Ability to establish strong partnership rapport with key internal and external stakeholders
• Capability to effectively collaborate with cross-functional team and communicate with leadership team
• Solid knowledge of the healthcare landscape such as hospital systems, various points of care, and the roles of relevant HCPs in the target Tas and the drug development process
• Exceptional self-management ability and able to self-motivate
• Strong understanding of compliance, and the legal and regulatory landscape as they relate to HCP interactions
• Fluent in Medical English listening, speaking, writing and reading is a must, other second language is a plus
• May require travel up to 50%

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.

The expected salary range for this position based in California is $180,000 to $220,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

Position Summary

We are seeking a highly skilled and compassionate Allergist/Immunologist Physician to join our growing practice in Greater San Diego, Greater South Bay LA, & New Prospect Locations. As a key member of our healthcare team, you will be responsible for diagnosing and treating patients with a wide range of allergic and immunologic conditions. You will provide high-quality care, collaborate with other medical professionals, and have the opportunity to work in a patient-centered, multidisciplinary environment.

The ideal candidate must be a self-motivated and eager individual who will establish him/herself in a practice that enjoys continuous growth. Must have excellent communication skills, bedside manner, and a strong work ethic with a desire to be part of a team that is committed to caring for the whole patient. We place special emphasis on providing patient-centered care, quality outcomes and patient satisfaction. If you are a dedicated and caring Allergist/Immunologist with an interest in advancing the field through clinical research and looking to make a difference in the lives of patients, we encourage you to apply. This is a unique opportunity to shape the future of allergy and immunology care while contributing to groundbreaking research in a collaborative and supportive environment. This role is exempt (salary) and full-time, working 40 hours per week, Monday through Friday with minimal travel. 

Key Responsibilities

• Clinical Responsibilities
  • Diagnose, treat, and manage patients with allergies, asthma, immunologic conditions, and related diseases.
  • Conduct comprehensive patient evaluations, including medical history, physical exams, and appropriate diagnostic tests (e.g., skin tests, blood tests, pulmonary function tests).
  • Develop and implement individualized treatment plans, including medication management, immunotherapy, and lifestyle modifications.
  • Educate patients and their families about managing allergies, asthma, and immunologic conditions.
  • Perform procedures such as allergy skin testing, spirometry, and immunotherapy (allergy shots).
  • Oversee in-office oral food challenges, drug challenges, and immunotherapy treatments (oral immunotherapy and sublingual immunotherapy for environmental and food allergy)
  • Develop and implement individualized care plans based on patient needs and medical history, including:
  • Starting allergy immunotherapy for environmental allergies
  • Starting oral immunotherapy for food allergy
  • Recommending food or drug challenges as part of allergy evaluation
  • Collaborate with other specialists (e.g., pulmonologists, dermatologists, primary care physicians) to ensure comprehensive care for patients.
  • Maintain accurate and up-to-date medical records in compliance with healthcare regulations and confidentiality standards.
  • Stay informed about the latest advancements in allergy and immunology treatments and participate in continuing medical education (CME).
  • Ensure high patient satisfaction and provide empathetic care, focusing on patient education and wellness.
  • Additional duties as assigned. 
• Research Responsibilities
  • Engage in clinical research initiatives through Orso Health, Modena Health’s research arm, related to the diagnosis, treatment, and prevention of allergic and immunologic diseases, or other areas of clinical interest.
  • Participate in designing and conducting clinical trials, including trials on new therapies, biologic treatments, and immunotherapy options.
  • Analyze data, prepare research reports, and collaborate with research teams to publish findings in medical journals.
  • Contribute to the development of innovative clinical pathways and treatment strategies based on research findings.
  • Work closely with industry partners, academic institutions, and research foundations to advance clinical studies in allergy and immunology.
  • Provide mentorship and guidance to junior researchers interested in allergy and immunology research.
  • Present research findings at national and international conferences.
  • Additional duties as assigned.

Qualifications & Requirements

• Education
  • Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree from an accredited medical school.
• Experience
  • Completion of an accredited residency in Internal Medicine or Pediatrics.
  • Successful completion of a fellowship in Allergy and Immunology.
  • Board certified or board eligible in Allergy and Immunology.
  • 1–3 years of post-fellowship clinical experience preferred; will consider highly qualified new fellowship graduates.
  • Demonstrated experience in diagnosing and managing patients with allergies, asthma, and immunologic conditions.
  • Hands-on experience performing and interpreting allergy testing, spirometry, and administering immunotherapy
• Licensure & Certifications
  • Board certification or eligibility in Allergy and Immunology (ABAI).
  • Valid and unrestricted medical license to practice in California.
• Skills & Abilities
  • Strong knowledge of allergy, asthma, and immunologic diseases and treatments.
  • Interest and experience in clinical research, including trial design and data analysis.
  • Excellent communication and interpersonal skills, with the ability to build rapport with patients and their families.
  • Ability to work effectively both independently and as part of a collaborative healthcare team.
  • Compassionate and patient-centered approach to care.
• Preferred Qualifications
  • Experience in a clinical or private practice setting.
  • Bilingual in Spanish (preferred but not required).
  • Expertise in immunotherapy and biologic treatments for allergy and asthma.
  • Experience in writing research protocols, grant submissions, or publishing research.
  • Interest in exploring innovative treatments and contributing to the advancement of immunology.

Compensation

The annual salary range for this position in California is $130,000-250,000/year. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate’s skills, education, and experience.

Position Summary

We are seeking a highly skilled and compassionate Allergist/Immunologist Physician to join our growing practice in Greater San Diego, Greater South Bay LA, & New Prospect Locations. As a key member of our healthcare team, you will be responsible for diagnosing and treating patients with a wide range of allergic and immunologic conditions. You will provide high-quality care, collaborate with other medical professionals, and have the opportunity to work in a patient-centered, multidisciplinary environment.

The ideal candidate must be a self-motivated and eager individual who will establish him/herself in a practice that enjoys continuous growth. Must have excellent communication skills, bedside manner, and a strong work ethic with a desire to be part of a team that is committed to caring for the whole patient. We place special emphasis on providing patient-centered care, quality outcomes and patient satisfaction. If you are a dedicated and caring Allergist/Immunologist with an interest in advancing the field through clinical research and looking to make a difference in the lives of patients, we encourage you to apply. This is a unique opportunity to shape the future of allergy and immunology care while contributing to groundbreaking research in a collaborative and supportive environment. This role is exempt (salary) and full-time, working 40 hours per week, Monday through Friday with minimal travel. 

Key Responsibilities

• Clinical Responsibilities
  • Diagnose, treat, and manage patients with allergies, asthma, immunologic conditions, and related diseases.
  • Conduct comprehensive patient evaluations, including medical history, physical exams, and appropriate diagnostic tests (e.g., skin tests, blood tests, pulmonary function tests).
  • Develop and implement individualized treatment plans, including medication management, immunotherapy, and lifestyle modifications.
  • Educate patients and their families about managing allergies, asthma, and immunologic conditions.
  • Perform procedures such as allergy skin testing, spirometry, and immunotherapy (allergy shots).
  • Oversee in-office oral food challenges, drug challenges, and immunotherapy treatments (oral immunotherapy and sublingual immunotherapy for environmental and food allergy)
  • Develop and implement individualized care plans based on patient needs and medical history, including:
  • Starting allergy immunotherapy for environmental allergies
  • Starting oral immunotherapy for food allergy
  • Recommending food or drug challenges as part of allergy evaluation
  • Collaborate with other specialists (e.g., pulmonologists, dermatologists, primary care physicians) to ensure comprehensive care for patients.
  • Maintain accurate and up-to-date medical records in compliance with healthcare regulations and confidentiality standards.
  • Stay informed about the latest advancements in allergy and immunology treatments and participate in continuing medical education (CME).
  • Ensure high patient satisfaction and provide empathetic care, focusing on patient education and wellness.
  • Additional duties as assigned. 
• Research Responsibilities
  • Engage in clinical research initiatives through Orso Health, Modena Health’s research arm, related to the diagnosis, treatment, and prevention of allergic and immunologic diseases, or other areas of clinical interest.
  • Participate in designing and conducting clinical trials, including trials on new therapies, biologic treatments, and immunotherapy options.
  • Analyze data, prepare research reports, and collaborate with research teams to publish findings in medical journals.
  • Contribute to the development of innovative clinical pathways and treatment strategies based on research findings.
  • Work closely with industry partners, academic institutions, and research foundations to advance clinical studies in allergy and immunology.
  • Provide mentorship and guidance to junior researchers interested in allergy and immunology research.
  • Present research findings at national and international conferences.
  • Additional duties as assigned.

Qualifications & Requirements

• Education
  • Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree from an accredited medical school.
• Experience
  • Completion of an accredited residency in Internal Medicine or Pediatrics.
  • Successful completion of a fellowship in Allergy and Immunology.
  • Board certified or board eligible in Allergy and Immunology.
  • 1–3 years of post-fellowship clinical experience preferred; will consider highly qualified new fellowship graduates.
  • Demonstrated experience in diagnosing and managing patients with allergies, asthma, and immunologic conditions.
  • Hands-on experience performing and interpreting allergy testing, spirometry, and administering immunotherapy
• Licensure & Certifications
  • Board certification or eligibility in Allergy and Immunology (ABAI).
  • Valid and unrestricted medical license to practice in California.
• Skills & Abilities
  • Strong knowledge of allergy, asthma, and immunologic diseases and treatments.
  • Interest and experience in clinical research, including trial design and data analysis.
  • Excellent communication and interpersonal skills, with the ability to build rapport with patients and their families.
  • Ability to work effectively both independently and as part of a collaborative healthcare team.
  • Compassionate and patient-centered approach to care.
• Preferred Qualifications
  • Experience in a clinical or private practice setting.
  • Bilingual in Spanish (preferred but not required).
  • Expertise in immunotherapy and biologic treatments for allergy and asthma.
  • Experience in writing research protocols, grant submissions, or publishing research.
  • Interest in exploring innovative treatments and contributing to the advancement of immunology.

Compensation

The annual salary range for this position in California is $130,000-250,000/year. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate’s skills, education, and experience.

Position Summary: 

Reporting to the CMO, the VP Global Pharmacovigilance has overall responsibility for drug safety activities for early and late phase assets, including furthering the development and implementation of the clinical development strategy. The VP will be accountable for overseeing safety and pharmacovigilance across development and expected global launches and, ultimately, post-marketed products. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PVG compliance.

Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.   

Essential Duties and Responsibilities:

• Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development.
• Represent GPV in communication with health and regulatory authorities.
• Represent GPV at independent Data Safety Monitoring Committee meetings.
• Provide medical oversight of the GPV function including medical review of all cases.
• Provide medical input for maintaining REMS, RMP safety monitoring commitments.
• In collaboration with other members of GPV, create and maintain a signal detection process for Erasca’s products with a clearly defined signal detection strategy for each asset.
• In collaboration with other members of GPV, ensure robust processes are implemented to meet REMS/RMP commitments.
• Overall responsibility for development and implementation of QPV, in collaboration with Quality and GPV Systems.
• Provide periodic benefit-risk assessment reports for internal use.
• Contribute to the preparation of, review, and approve aggregate safety reports required by health authorities.
• Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc).
• Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates.
• Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis.
• Build and lead highly functioning GPV team including Safety Operations and Safety Science, utilizing internal and external resources.
• Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met.
• Assess process, systems, and staffing needs to scale for multiple late-stage trials, including oversight of CROs and vendors.
• Develop and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs.
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Required Education and Experience:

• Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development required; PharmD or other relevant clinical degree may be considered.
• 12 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred.
• Excellent scientific and clinical and analytical knowledge base, with the ability to assess data and understand safety and medical implications.
• In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation.
• Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred.
• Extensive experience interfacing with US (FDA) and x-US health authorities required. Experience executing clinical trials in China, reporting safety data to China health authorities preferred.
• In depth knowledge of Safety Science and Safety Operations disciplines, with exposure to both internally and externally managed safety systems and databases.
• Direct management experience with proven ability to effectively lead, coach, mentor, and manage others.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
• Strong learning orientation, curiosity, and commitment to science and patients.

The anticipated salary range for this position is $370,000 to $390,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.