ESSENTIAL JOB FUNCTIONS:

• Manage Senior Accountant and ensure timely, accurate processing of journal entries, reconciliations and various account analyses for R&D functions such as translational research, development, diagnostics, pharmacology, and regulatory affairs, and adherence to company policies.
• Review and approve invoices for payment. Ensure proper coding, two-way match, and approval workflows.
• Perform and review journal entries and balance sheet reconciliations for key accounts such as accrued R&D contracts, prepaid R&D ST, and prepaid R&D LT.
• Review various related parties and partner transactions including reconciliations, and analysis.
• Perform and review monthly and quarterly variance analyses for operating expenses, R&D functions, projects, and key accounts; investigate and resolve discrepancies proactively.
• Ensure compliance with U.S. GAAP, SOX requirements, and internal accounting policies across all responsible functions and processes.
• Support the design, implementation, and ongoing maintenance of Sarbanes‑Oxley internal controls, including documentation and testing.
• Assist with external financial audits by preparing schedules and responding to auditor requests and inquiries.
• Review monthly purchase order coding, partner with project managers and accounting staff to ensure proper coding for all new purchase orders.
• Apply strong analytical skills and critical thinking to identify issues, recommend improvements, and enhance the accuracy, efficiency, and quality of accounting processes.
• Perform additional duties and ad hoc projects as needed to support Finance leadership and departmental goals

Job Specifications:

• Bachelor’s degree in accounting, or other related discipline, or the equivalent knowledge and experience required.
• Experience in the biotech/pharmaceutical industry required
• A minimum of 6-8 years’ relevant accounting experience, preferably in a combination of the following monthly close process, bank reconciliations, balance sheet reconciliations, contract accruals
• Excellent communication and people skills and the ability to interface with various levels of co-workers, upper management, and external customers while maintaining a high degree of confidentiality.
• Experience working in publicly traded company and life science industry preferred.
• Knowledge of US GAAP and internal control principles for a public corporation.
• ERP experience required; experience with NetSuite, Blackline, Coupa and Concur preferred.
• Skilled in the use of Microsoft Office Suite with intermediate to advanced Excel skills.
• Detail oriented with good analytical skills.
• Exercises independent judgment in managing operational decisions within their area; proactively identifies issues and determines when to escalate more complex or cross-functional decisions.
• Serves as a key point of contact for cross-functional partners withing their area, ensuring alignment and proactively addressing coordination needs to support team deliverables.
• Strong time management skills and ability to independently organize multiple tasks of varying priorities and meet critical deadlines in a fast-paced environment.
• Ability to work in team environment and willing to assist other team members to achieve team goals and objectives.

The base range for this role at a Senior Manager level is $143,000 - $176,500. 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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ABOUT AVANTUS

Avantus develops, owns, and operates utility-scale clean energy projects across California and the Desert Southwest. Our development pipeline represents one of the nation's largest portfolios of solar with integrated storage, capable of providing dispatchable power to 17 million Americans, day and night. With over a decade of industry leadership and strategic investment from KKR and EIG, Avantus delivers affordable, reliable clean energy solutions that meet America’s growing energy demand.

ABOUT THE POSITION

We are seeking a highly motivated candidate to lead Avantus’ tax function and be a strategic advisor to senior leadership on all tax matters. The successful candidate will have depth and breadth of tax experience supporting the development of utility scale solar and battery storage projects, subchapter K (partnership tax) and demonstrate sound industry knowledge, and judgement. The role will be responsible for overseeing and managing all aspects of the tax function for the Company.  

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES 

• Provide tax advice to support the development of 5 GW of utility scale solar and battery storage projects 
• Identify and implement opportunities to maximize the use of renewable energy tax incentives, including federal and state tax credits, property tax abatements, and sales/use tax exclusions 
• Ensure compliance with prevailing wage and apprenticeship requirements and foreign entities of concern restrictions
• Develop and execute a comprehensive tax strategy aligned with the company’s growth objectives
• Support financing of projects and the company, including structuring tax equity transactions 
• Identify and mitigate tax risks across all jurisdictions.
• Manage audits, inquiries, and relationships with IRS, state and local tax authorities
• Support the Project Finance team model and forecasting
• Identify and drive the implementation of tax planning initiatives 
• Manage tax risk, coordinate the tax planning and reporting functions and ensure appropriate documentation to support lender/investor due diligence 
• Perform feasibility analyses of various tax initiatives to improve tax efficiency and support the strategic goals of the Company.
• Perform due diligence, structure and advise senior management on the tax implications of acquisitions and strategic partnerships 
• Manage relationships with external tax advisors and/or legal counsel.
• Actively monitor US, state, and tax legislative and judicial actions, analyze potential impacts/benefits and support the Senior Vice President of Legislative and Regulatory Affairs
• Work cross-functionally with business partners and other corporate functions such as legal, business units, supply chain on new business initiatives, new market penetrations and operations, and tax-efficient supply chain structures implementation 
• Provide GAAP, cash tax and FP&A tax forecasts 
• Oversee preparation and filing of all federal, state and local income, property and sales tax returns  

REQUIRED SKILLS AND QUALIFICATIONS

• J.D. or C.P.A.
• 10–15+ years of progressive tax experience, including leadership roles
• Extensive experience in the renewable energy industry, including partnership taxation, tax credit initiatives, debt financing, and tax equity financing
• Strong analytical and critical thinking skills, with the ability to manage tax advisors.
• Excellent decision-making capabilities with a thorough understanding of various drivers impacting the decision.
• Excellent communication and interpersonal skills. Must be able to communicate efficiently and effectively with all team members including our Senior Executive team.  
• A strong sense of urgency, positive outlook, and a proactive work ethic approach in a fast-paced work environment 

NICE TO HAVES

• L.L.M. or Masters in Taxation
• A background in all facets of accounting for income taxes, including U.S. tax provisions  

#LI-Remote

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

Position Summary

Primary Responsibilities

• Develop materials to support GAP internal communications and external advocacy programs.  These may include internal newsletters, intranet content, program updates, talking points, slide decks; and external advocacy materials such as draft letters, emails, infographics and other collateral for use in advocacy programs
• At the direction of the Director of State Government Affairs, build strong and productive relationships with relevant state and local elected officials, community-based organizations, and civic partners to elevate Acadia’s visibility and drive successful outcomes for policy priorities
• Monitor state legislative and regulatory developments and provide timely analysis and updates to internal stakeholders
• Represent Acadia in relevant state and local trade associations and coalitions (e.g., BIOCOM, California Life Sciences Association, BioNJ)
• Partner with internal functions to develop briefing materials, policy positions, and presentations tailored to state and federal stakeholders
• Support the entire GAP team and work closely with our internal partners on the AIR, Commercial, Communications, Medical, R&D, Regulatory teams and others as directed
• Other duties as assigned.

Education/Experience/Skills

• Bachelor’s or Master’s degree in a relevant field such as health care administration or public policy, or equivalent relevant experience, with 5+ years of experience in health care policy and a strong understanding of today’s complex health care policy landscape.
• Proven ability to communicate effectively in both verbal and written formats
• Experience anticipating public policy trends in the health care sector
• Strong understanding of the current political environment and of policy-making processes at the state and federal level, including both legislative and regulatory processes
• Experience working across multiple functions within an organization to advance team- and enterprise-level goals
• Demonstrated ability to work collaborative and achieve consensus across a matrix environment
• Capable of managing multiple projects simultaneously with precise attention to detail, quality, and timelines.

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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#LI-CS1

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.

#LI-RM1

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

Position Summary 

Acadia Pharmaceuticals is seeking a seasoned and strategic Health Economics and Outcomes Research (HEOR) leader to serve as Senior Director, HEOR. In this critical role, you will lead the development and execution of comprehensive value evidence strategies that demonstrate the clinical, economic, and humanistic value of Acadia’s therapies across their lifecycle, from development through commercialization and global market access.

As the demand for high quality real world evidence and outcomes research continues to grow, this role will be central to supporting health technology assessments, payer decision making, reimbursement, and product differentiation. You will oversee the generation and dissemination of HEOR evidence, including real world evidence, economic modeling, and clinical outcomes assessments, to support access and adoption across global markets.

The Senior Director, HEOR will be responsible for shaping and communicating the value story for assigned products or indications, leading the development of global value dossiers, economic models, and HTA strategies that clearly articulate the benefit of Acadia’s therapies to patients, healthcare systems, and population health decision makers. This role requires close collaboration with Commercial, Market Access, Clinical Development, Medical Affairs, Regulatory, and other cross functional partners to ensure HEOR strategies are aligned with scientific objectives, business priorities, and regulatory expectations.

The ideal candidate brings deep expertise in outcomes research methodologies, strong scientific and strategic judgment, and the ability to lead complex, cross functional initiatives in a fast paced, global environment. This position offers a unique opportunity to shape evidence strategies that influence access, reimbursement, and ultimately patient outcomes for therapies addressing significant unmet medical needs.

Primary Responsibilities

• Build and implement the strategy for HEOR, including RWE and HTA evidence generation & dissemination within an assigned area for in-line and pipeline assets.
• Lead delivery of value evidence generation strategies throughout the product life cycle.
• Oversee and guide the development and implementation of patient-reported outcomes (PRO) and COA endpoints strategy.
• Ensure the work delivered by HEOR in the assigned area aligns with R&D and corporate goals.
• Represent HEOR on various cross-functional teams in commercial/clinical/medical areas.
• Direct and implement relevant HEOR initiatives with external entities.
• Contribute to the development and execution of overall and HEOR-specific publication plans.
• Establish an integrated HEOR plan aligned with Commercial, Market Access, and Scientific objectives.
• Other duties as assigned.

Education/Experience/Skills

• Master’s degree in public health, economics, epidemiology, health services research or HEOR-related field. 
• Targeting 12 years’ experience in the pharmaceutical or medical device industry; or, a Doctorate in health services research, pharmacy, medicine, public health, economics, and targeting 9 years’ experience in global biopharmaceutical or medical device industry. 
• Experience in outcomes research methodologies (retrospective observational cohort, cross-sectional studies, registries, etc.) to support product development and reimbursement efforts is required. 
•  Must have experience with the execution of scientifically robust qualitative and quantitative studies, development and validation of COA measures, including assisting clinical development teams in implementing COAs in clinical trials to measure patient-relevant endpoints.

Key Skills:

• Understanding of the global healthcare environment, clinical research processes, global regulations, and ethical guidelines.
• Rare disease or CNS experience with interactions with US and ex-US reimbursement agencies is preferred.
• Highly developed communications skills (written/verbal) and interpersonal savvy.
• Proven meeting planning and team facilitation skills.
• Ability to create, track, plan, and communicate project timelines to team members, and maintain budgets.
• Ability to create, track and plan timelines and budgets.
• Ability to support multiple projects while being well-organized, have strong time management skills, and attention to detail.
• Excellent organization and multi-tasking skills.
• Ability to accommodate shifting priorities, demands and timelines.
• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.
• Knowledge of regulatory guidance documents and scientific guidelines (FDA guidance; FDA qualification documentation; dossier outline; EMA guidance resources; ISPOR Task Force Documents, etc.).
• Understanding of instrument development and validation process.
• Strong computer skills (Microsoft Office, etc.) and knowledge of database management (Veeva Vault, etc.).
• Must be able and willing to travel (up to approximately 40%) for conferences, meetings, and HEOR project or team-management related business.

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-SW1

#LI-Hybrid

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

Position Summary:

The Director, Marketing will contribute to the development of the overall Consumer strategy of the brand while leading the management and execution of marketing tactics, plans and activities to promote the brand to caregivers. This role is responsible for shaping patient and caregiver messaging across channels, including direct-to-consumer (DTC) television advertising and educational materials, while ensuring alignment with brand strategy, regulatory standards, and patient-centric principles. The Director will deliver impactful communications that meaningfully engage the caregiver community, and will play a key leadership role within the consumer marketing team. This role will partner across key stakeholders (advocacy, medical affairs, regulatory, legal, compliance, patient services, market access, marketing operations, training, sales, etc.) to execute the programs and tactics identified in the brand plan.

Primary Responsibilities:

• Lead the development and execution of consumer and caregiver marketing initiatives, including core messaging, direct-to-consumer (DTC) television advertising, and educational materials designed to inform, support, and empower families within the Rett community.
• Oversee the caregiver speaker program, including speaker identification, onboarding, and management; development of compliant, engaging speaker content; and ongoing evaluation and optimization of program effectiveness.
• Ensure caregiver speaker materials and presentations are scientifically accurate, compliant, and aligned with brand strategy, with a strong emphasis on clarity, empathy, and patient- and caregiver-focused storytelling.
• Serve as the primary marketing liaison to the Family Support Educator (FSE) team, ensuring alignment between consumer marketing initiatives and field-based educational efforts to deliver a cohesive and consistent caregiver experience.
• Directs the development of strategic marketing programs for inclusion into brand plan, determines metrics for program success, and evaluates performance against metrics including contributions to the development and evolution of message strategy based upon in-depth analytics and ROI analysis. Manages within the established the US promotions budget for assigned products.
• Represents the department as a member of cross-functional project teams providing guidance, insight, and recommendations relative to the goals and objectives of the Marketing function to ensure strategic alignment medical education messaging across groups.
• Monitors and ensures that all Medical Legal Review (MLR) processes are followed, and all programs are compliant with legal guidance and corporate policies.
• Implements the brand strategy for products and product lines. Develops and delivers presentations as needed to commercial management and other internal groups. Monitors progress of plans and recommends adjustments, as necessary.
• Develops and maintains strong external relationships with Advocacy groups, physician speakers and Rett caregivers and families.
• Mentor and develop junior team members by providing clear direction, coaching, and constructive feedback, fostering strong marketing fundamentals, professional growth, and a collaborative, high-performing team culture.Lead day-to-day collaboration with the advertising agency of record, providing strategic direction and hands-on oversight across creative development and execution to ensure consumer-facing campaigns are aligned with brand strategy, patient-centric principles, timelines, and budget.

Education & Experience:

• Bachelor’s degree in marketing, health care, life science; master’s degree preferred.
• Targeting 10+ years of progressively responsible experience in pharmaceutical or biotech Marketing.
• 5+ years in a product manager role strongly desired.
• Launch experience and commercialization of new products preferred.

Required Skills:

• Rare Disease experience is highly desirable, with requirement of understanding specialty therapeutics addressing significant unmet medical needs.
• Strong Biopharmaceutical brand management experience and demonstrated track record of success.
• Proficient in marketing and media tactics directed towards HCPs and caregivers.
• Proficient at effectively prioritizing goals and coordinating resources to achieve those goals.
• Demonstrated ability to interface/collaborate with other departments as necessary to achieve goals.
• Significant travel required; ability to travel up to 50% of time during peak launch time periods.

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 by car or airplane independently overnight up to 25% of the time and work after hours if required by travel schedule or business issues.

#LI-SM1 #LI-HYBRID

OPEN POSITION ANNOUNCEMENT!

Program Associate 

Open until filled.

Posted 04/23/2026 San Diego County - hybrid work schedule set by Community Power

ABOUT THE ROLE: The Program Associate supports the implementation of a range of customer energy programs, primarily through the San Diego Regional Energy Network (SDREN). This role, under direction and support from senior staff, will assume responsibility for more than one aspect of program development, delivery and management, and contribute to several other aspects including goal setting, budget development/management, process development, program marketing and enrollment, regulatory reporting (if necessary) and stakeholder engagement. The Program Associate may coordinate programmatic activities with consultants and collaborate with internal project teams.  

This role will be reporting to a Senior Program Manager. 

WHO IS COMMUNITY POWER?

Community Power is a community-driven, not-for-profit public agency providing cleaner energy to the San Diego region. Formed in 2019, Community Power is the second largest Community Choice Aggregator (CCA) in California, serving nearly 1 million customer accounts across its member agencies: the Cities of San Diego, Chula Vista, Encinitas, Imperial Beach, La Mesa and National City, as well as the unincorporated areas of San Diego County.  

OUR HISTORY

Community Power was formed in 2019 as a public, not-for-profit community choice aggregator (CCA) in the San Diego region. We began electric service in 2021 and now serve seven member agencies: the Cities of San Diego, Chula Vista, Encinitas, Imperial Beach, La Mesa and National City, as well as the unincorporated communities of San Diego County. Community Power was formed to bring local control and customer choice to San Diego while also providing clean and renewable energy at competitive rates. We are the second largest CCA in California, serving nearly 1 million customers. For more information, please visit SDCommunityPower.org.

COMMITMENT TO DIVERSITY

At Community Power, we value diversity and are committed to creating an inclusive environment for all employees. We represent a diverse customer base and hope to hire employees that reflect our communities. We provide equal employment opportunities to all applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 

ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES

• With oversight from senior staff, develop standard operating procedures, review, process and seek opportunities for efficiencies and improvements. 

• Support senior staff with the coordination, management and implementation of customer-facing programs by working closely with Community Power staff, the Community Advisory Committee, consultants, stakeholders, and other partner agencies.  

• Support senior staff with aspects of project planning and scoping including collaborating on budgeting, procurement, staffing, scheduling and metrics development. 

• Support senior staff with developing and conducting requests for proposals and negotiating, implementing and managing contracts. 

• Coordinate independently with industry, consultants, customers and other stakeholders involved in program delivery and implementation. 

• In coordination with the Public Affairs team, lead aspects of program-related community outreach and education initiatives including making presentations to stakeholders and community groups and coordinating event logistics.  

• Assist in a broad variety of program-related data collection, organization and analysis. Prepare progress reports on a regular basis and clearly communicate updates to senior staff. 

• Work closely with the SDREN team to maintain program management tools and create programmatic tracking reports and dashboards. 

• Monitor program progress in assigned program area(s) relative to goals and make recommendations for improved program delivery. 

• Field inquiries from the public and industry to answer program-specific questions and/or refer to the appropriate staff. 

• Support the drafting of staff reports and presentations for Board of Directors and Community Advisory Committee meetings. 

• Perform other related duties and responsibilities as required. 

KNOWLEDGE, SKILLS, AND ABILITIES

• Experience in or interest in supporting the implementation of programs in one of the following areas: energy efficiency, building decarbonization, demand response, and distributed energy resources (DERs). 

• Strong commitment to sustainability, community energy and mission driven work. 

• Commitment to diversity, equity and inclusion within the organization and in our communities to build program accessibility and participation, including Community Power’s Communities of Concern. 

• Knowledge and understanding of the fundamentals of environmental justice and equity principles. 

• Knowledge and basic understanding of the CCA business model. 

• Establish effective and cooperative working relationships with customers, local businesses, community groups, consultants, interested stakeholders, officials of municipalities, agencies, special districts and other related agencies. 

• Positive, collaborative and supportive team member that is excited to work with diverse teams and communities. 

• Ability to work independently, strong organizational skills and demonstrated goal setting and self-management to support multiple assignments concurrently. 

• Strong work ethic and comfortable taking responsibility, initiative and working in a dynamic, fast spaced, public agency environment. 

• Strong communicator who can write and present compellingly and clearly. 

• Ability to take and provide critical feedback in constructive ways. 

• Strong critical thinking skills including a high tolerance for uncertainty and the ability to identify issues and propose solutions. 

• Ability to act with integrity, professionalism and confidentiality. 

• Ability to comprehend and adhere to Community Power personnel policies. 

• Proficiency with Microsoft Office Suite, Word, Excel and PowerPoint and ability to use virtual meeting applications. 

• Experience with data analysis and data modeling and ability to present it visually. 

• Experience working with office procedures and practices including correspondence etiquette, and operating office equipment, technology and programs. 

• Ability to travel to meetings and community events to meet with residents and stakeholders. Must have access to reliable transportation, and if driving an automobile, a good driving record. Community Power will reimburse mileage expense at the IRS mileage rate. 

Preferred:  

• 2-3 years of experience supporting the implementation of programs in one of the following areas: energy efficiency, building decarbonization, demand response, or distributed energy resources (DERs). 

• 1-2 years of experience at a Regional Energy Network (REN), Community Choice Aggregator (CCA), investor-owned utility, public utility, other public agency or 3rd party program implementer.  

• Proficient in digital tools and systems (i.e., Customer Relationship Management) to manage programs and work with quantitative data. 

• Ability to represent the organization in various professional engagement settings from local to national convenings (conferences, workshops, executive meetings, etc.). 

• Proficient in verbal communication in multiple languages, Spanish and English preferred. 

QUALIFICATIONS, EXPERIENCE, AND ABILITIES

Any combination of education and experience that would provide the knowledge, skills and abilities listed. A typical way to obtain the required qualifications would be:  

A four-year degree or higher from an accredited college or university AND a minimum of two (2) to three (3) years of professional experience. Four (4) additional years of professional experience may be used in place of a degree. A graduate degree may substitute for one year of professional experience. 

WORK ENVIRONMENT AND CONDITIONS

Prolonged periods sitting at a desk and working on a computer. The position requires occasional carrying, lifting and/or moving objects up to 25 pounds. Occasional local travel required and reliable transportation to be able to attend SDCP events, meetings, and workshops as needed is expected. 

At Community Power we work in the communities we serve and in the office. Community Power works to ensure a safe and healthy workplace for employees and in our communities. Community Power requires employees to be fully vaccinated for COVID-19. Exemptions to the vaccine requirement will be considered for individuals with medical conditions that prevent them from being vaccinated and for individuals with sincerely held religious beliefs that prohibit them from being vaccinated, consistent with governing labor laws.

Community Power is an agency required to adopt and promulgate a Conflict-of-Interest Code (“COI”). The COI code requires employees in designated positions, including those identified under the interim disclosure process, to file a Statement of Economic Interests (Form 700) on an annual basis. A Successful candidate accepting this position may be required to file Conflict of Interest forms subject to the regulations of the Fair Political Practices Commission. 

Compensation: 

Salary Range: The position salary range is: $84,900 - $110,400; with exact compensation to be determined by Community Power, depending upon experience. 

Benefits: Standard benefits package including but not limited to:

Insurance: Community Power covers 100% of health benefits, including medical, vision, and dental insurance, for eligible FT employees and their dependents. Also provided is a $100,000 Life & AD&D policy, STD and LTD coverage that is 100% paid by Community Power.

Retirement: Community Power offers a 457(b) plan for employee contributions and contributes 10% of eligible compensation to the employee’s Money Purchase Plan.

Paid Time Off: 11 holidays per year + paid winter holiday (between 12/24-12/31), 160 hours of accrued paid time off per year (increases with time in service), and 96 hours per year of accrued paid sick leave.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at the discretion of Community Power as needed. 

Position Summary

The Director/Senior Director of Global Regulatory Affairs (GRA) will report to the Senior Vice President of Regulatory Affairs and serve as a key leader in shaping and executing global regulatory strategies. This role will partner closely with the GRA team and cross-functional stakeholders to ensure compliance with international regulatory requirements and alignment with company objectives. The candidates major responsibilities will include the following:

• Regulatory Strategy & Advice: Develop and execute integrated regulatory strategies that optimize approval pathways for drug and device across all regions where clinical studies are conducted. Provide expert guidance on global regulatory requirements, life cycle management and evolving policies where RM is pursuing development and commercialization.

• Submission Oversight: Lead cross-functional teams to prepare high-quality regulatory submissions. Review and ensure consistency of regulatory documents with company strategy and health authority standards; manage submission strategies for all Rakuten Medical projects from early-stage (IND/CTA) through NDA/BLA and lifecycle management. Oversee planning and execution of global regulatory authority meetings, including briefing packages, strategy, positioning, and negotiations.
• Documentation & Compliance: Ensure compliance with all applicable global laws, regulations, and standards (eg FDA CFR, EMA guidelines, ICH, PMDA standards, EU MDR/IVDR, GCC regulations). Maintain regulatory filing and archiving systems; ensure documentation meets health authority requirements and guidance.
• Project Management: Develop regulatory project plans and timelines; coordinate submission team and regulatory department meetings; track goals, action items, and submission progress. Manage various regulatory vendors and contractors toward budget- and time-efficient completion of corporate goals. Proven ability to apply strong influence skills in leading cross-functional regulatory submission teams.
• Cross-Functional Collaboration: Work closely with teams in CMC, nonclinical, clinical development, medical writing, safety/PV, quality assurance, medical affairs, and program management to support timely and compliant submissions. Assess regulatory risk and drive mitigation strategies to support business continuity.
• Global Tracking: Monitor regulatory commitments, deliverables, and submission content across regions.

This position spans all functional areas requiring regulatory input, including early research, CMC, device, nonclinical, clinical development and commercial. The ideal candidate will bring strong leadership, strategic thinking, and deep knowledge of global regulatory frameworks to drive successful outcomes.

Key Duties and Responsibilities 

• Develop and execute integrated global regulatory strategies for drug and device programs across all regions as required.
• Maintain a thorough understanding of current and emerging global and regional regulations, guidance documents, and ICH standards for all application types and procedures, in all regions where the organization seeks to develop and commercialize products.
• Stay informed on regulatory requirements for biologics and combination products across all regions.
• Develop and manage submission strategies for all Rakuten Medical projects and planned submissions. Ensure regulatory documents are scientifically sound, consistent, and aligned with company strategy and health authority expectations.
• Coordinate and oversee the planning, preparation, and delivery of regulatory submissions throughout the product lifecycle—from preclinical and IND/CTA through clinical development, NDA/BLA, and ongoing lifecycle management.
• Serve as the primary interface with publishing and other regulatory vendors; review submissions for completeness and compliance with regulatory guidance and health authority expectations.
• Lead implementation of new regulatory systems and develop associated processes and SOPs.
• Manage regulatory project tracking tools to monitor deliverables, commitments, submission content, amendment and approval dates, and provide proactive status updates for all regions.
• Act as the primary regulatory lead on assigned project teams, providing strategic input and regulatory support.
• Ensure timely storage and archiving of regulatory documentation in a manner that facilitates efficient retrieval.
• Conduct regulatory review of external-facing materials (e.g., manuscripts, posters) as appropriate.
• Review clinical, CMC, and safety documentation to ensure regulatory compliance and completeness during authoring and finalization.
• Coordinate safety reporting and collaborate with Safety/Pharmacovigilance to ensure systems are in place for efficient tracking and reporting of safety information.
• Assist with onboarding new employees and manage consultants and related contracts as needed.
• Contribute to continuous improvement of operational processes for regulatory submissions and document trackin. 

Qualifications:

• Education:
  • Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline (M.S., Ph.D., or Pharm.D.).

• Experience:

• • 10+ years of regulatory affairs experience in the biopharmaceutical industry, with at least 5 years in a leadership role.
  • Proven track record of managing global regulatory submissions (IND/CTA, NDA/BLA, MAA) and lifecycle management.
  • Experience in oncology or biologics preferred; combination product/device experience is a plus.

• Knowledge:

• • Deep understanding of global regulatory frameworks (FDA, EMA, PMDA, and other major health authorities).
  • Familiarity with ICH guidelines, GCP, and evolving regulatory trends.

• Technical Skills:

• • Expertise in regulatory strategy development and execution.
  • Strong document review and submission planning skills.
  • Proficiency with regulatory information management systems and electronic submission platforms (eCTD).

Key Competencies:

• Strategic Thinking: Ability to anticipate regulatory challenges and develop proactive solutions aligned with business objectives.
• Leadership & Collaboration: Skilled at leading cross-functional teams and influencing stakeholders across global regions.
• Communication: Exceptional written and verbal communication skills for health authority interactions and internal alignment.
• Project Management: Strong organizational skills with the ability to manage multiple priorities and meet tight deadlines.
• Problem-Solving: Analytical mindset to resolve complex regulatory issues and adapt to changing requirements.
• Integrity & Compliance: Commitment to ethical standards and regulatory compliance in all activities.

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 $150,000 to $190,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

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: 

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.