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Associate Director Clinical Assay Strategy Transplant & Immunology and Immunoglobulins
CSL Behring 4.6
Associate director job in Waltham, MA
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay.
You will be part of a specialized non-laboratory based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry best practices are essential. The incumbent will have a broad and deep knowledge base in relation to development and validation of PK, ADA and biomarker assays. This role requires high excellent communication and influencing skills to effectively collaborate with internal stakeholders in cross functional teams and execute externalization of compliant bioanalytical and biomarker assays . The candidate will need to have a deep understanding the regulatory requirements across bioanalytical and biomarker assay as it relates to different platforms, assay types and context of use.
Main Responsibilities:
Leadership and Strategy
Develop and implement bioanalytical/biomarker strategies to support clinical bioanalysis that aligns with the company's overall goals and objectives, supporting clinical programs with moderate complexity.
Within a matrix environment provide leadership and mentor scientists within and across functional groups, fostering innovation and excellence.
Participate in external due diligence and provide expert advice on bioanalytical and biomarker assays, data quality, regulatory expectations, clinic/submission readiness and associated risks.
Research and Development
Ensure the timely support for progression of projects from nonclinical development through all phases of clinical development, including submissions and post marketing requirements.
Direct the strategy and implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance. Identify and proactively manage risk with externalization of critical bioassays.
Establish operational plans to ensure the success technical transfer of assays to external vendors with required compliance, concordance, quality and within timelines to meet project requirements.
Project and Resource Management
Work with Clinical Bioanalytics and Biomarker leadership team to execute robust insourcing outsourcing strategy, ensuring strategic decisions and effective utilization of available resources.
Support the selection of vendors through in depth technical, strategic and scientific review. Contribute to governance meetings, escalation of issues and tracking of KPIs.
Optimize workflows to ensure optimal turn around times, assay transfers, budgets, and resource allocation.
Scientific Oversight
Interpretation of moderate complexity data, ability to troubleshoot and define next steps across areas of expertise for often complex issues.
Recognized subject matter expert in job area typically obtained through advanced education and work experience.
Provide scientific guidance and expertise across the Clinical Bioanalytics and Biomarkers function.
Ensure best practices in experimental design, data analysis, and compliance with regulatory requirements to support project needs.
Contribute to the preparation and review of regulatory submissions, providing expert input on bioanalytical and biomarker data responding to regulatory queries
Communicate scientific results clearly and concisely to appropriate audiences.
Collaboration and Networking
Initiate and foster partnerships with cross-functional CSL R&D teams, external vendors, industry experts, and collaborators to ensure timely project progression and risk management.
Represent the organization at scientific conferences and industry meetings.
Innovation and Technology
Drive innovation by using up-to-date latest advances in platforms, bioanalytical/biomarker formats, assay design and data analysis, automated workflows and use of AI in regulated environments.
Stay updated on advancements throughout the field to support current and emerging modalities.
Qualifications and Experience Requirements:
Postgraduate degree (preferably PhD) and extensive experience in clinical biomarker/bioanalytical assays or a related field, Hematology/CVR/Transplant/Immunology.
8+ years' relevant industry experience and / or equivalent experience in a relevant academic environment.
Strong and proven scientific background in relevant Life Sciences discipline.
Demonstrated ability in managing highly effective teams that are cross-functional, multicultural and international.
Deep understanding of relevant regulatory guidance's and industry best practices.
Excellent analytical skills, ability to address complex problems through investigation and analysis.
#LI-HYBRID
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$112k-169k yearly est. Auto-Apply 4d ago
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Associate Director - Statistics
Takeda 4.7
Associate director job in Cambridge, MA
Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
Our Data and Quantitative Sciences(DQS) is committed to harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.
As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence.
Delivery & Business Accountabilities:
Lead delivery for one or more assets at GPT level or specialty area in clinical
Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors
Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission
Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation
Create an internal cross functional and external with vendors sphere of influence in predictable delivery
Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them
Contributions:
Asset-level GPT strategy and delivery
Broadly DQS functions
Parts R&D functions.
Core Elements Related to this Role:
Advanced knowledge of clinical study designs, analysis methodology and data interpretation.
Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
Strong statistical programming skills
Excellent oral and written communications skills.
Specialized statistical expertise in multiple therapeutic areas or development phases.
Strong inter-personal and people management skills.
Strong project management skills.
Strong collaborative skills and ability to work with a cross-functional team.
Technical/Functional (Line) Expertise:
Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics
Scientific understanding of drug R&D to inform methodological input with product team or in a platform
Strong communication skills and ability to translate effectively across functional lines
Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs that he/she is involved in
Leadership:
Lead one or more assets at GPT level or specialty area in preclinical, clinical, translational
Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D
Enable the tactical execution of the SQS and DQS vision and mission
Lead and be accountable for asset level strategies being implemented
Demonstrate mentorship, matrix or direct management of small team of SQS colleagues
Create an internal and external sphere of influence in area of expertise
Education:
PHD with ~ 5 years experience
MS with ~ 8+ years experience
Behavioral Competencies:
Inspire teamwork
Assess benefit risk of options
Develop understanding of business beyond SQS
Focuses on priorities
$128k-194k yearly est. 3d ago
Chief Operating Officer
KLR Executive Search Group LLC 4.2
Associate director job in Providence, RI
KLR Executive Search Group is proud to partner with a full-service business law firm to identify a commercially savvy, Chief Operating Officer (COO) to manage daily operations and lead the execution of the firm's growth strategy. This leader will translate strategic goals into scalable systems, policies, and staffing models across multiple offices, ensuring the firm has the infrastructure needed to support continued expansion. The COO will partner closely with practice and department leadership, oversee modernization initiatives, and drive cross-office alignment as the firm continues toward long-term growth targets. Ideal candidates will have experience scaling organizations ($100M+ revenue), ideally within professional services or law firms, and a track record of operational excellence. Ideally, this position will be hybrid and based out of the firm's Boca Raton, FL or Providence, RI offices.
Core Responsibilities:
Operational Leadership
Oversee daily operations across all offices, ensuring seamless coordination, scalability, and alignment with strategic goals.
Manage HR functions including recruiting, onboarding, retention, and performance management, while planning future HR initiatives.
Partner with department heads to align staffing with strategic priorities and maintain high-performing teams.
Direct facilities management, vendor partnerships, and operational logistics, while identifying innovation opportunities to enhance efficiency and collaboration.
Technology & Process Innovation
Standardize workflows, optimize client intake, and lead initiatives to improve internal coordination and service delivery across all offices.
Implement and adopt technology solutions to enhance efficiency, collaboration, and client service, while partnering with CFO/CIO on data integration and performance tracking.
Financial Management and Resource Allocation
Partner with the CFO and firm leaders to manage budgeting, forecasting, pricing, and profitability, while ensuring strong cash flow and scalable operational planning.
Develop and execute staffing and capacity plans, control operational expenditures, and deliver clear financial and performance reporting to senior leadership.
Risk and Compliance Support
Support the CLO and CCO by aligning operational policies with risk management, monitoring legal and regulatory compliance, and enforcing standards across HR, safety, and administrative functions.
Qualifications:
Executive operational leadership experience in professional services or law firms, with a track record of scaling organizations ($100M+ revenue).
Strong strategic planning and execution abilities, translating firm-wide goals into systems, processes, and staffing that support growth across multiple offices.
Expertise in operational oversight, including HR, finance, technology, facilities, vendor management, workflow optimization, and technology integration.
Exceptional leadership and communication skills, able to collaborate effectively with attorneys and executives in a fast-paced, growth-oriented environment.
The firm has main offices in Boca Raton, FL and Providence, RI, we would be looking for local candidates only or people who are willing to relocate to these areas.
The salary range for this position is $190,000 - $350,000 and does not include benefits and bonus potential. Compensation is determined by a variety of factors including but not limited to the role, function, and associated responsibilities, as well as a candidate's work experience, education, knowledge, skills, and geographic location.
$190k-350k yearly 4d ago
Senior Director, SOX Project Management Office
Keurig Dr Pepper Inc. 4.5
Associate director job in Burlington, MA
Senior Director, SOX PMO (Global Lead)
Company: Large Multinational Consumer Products/Manufacturing Company (Origin: Netherlands)
Status: Preparing for U.S. IPO
Shape The Future Of Global Coffee Company
Are you ready to lead a world-class SOX compliance program at the center of a major acquisition and transformation? As Keurig Dr Pepper prepares to acquire JDE Peet's, a publicly traded European multinational (non-SOX compliant), and merge it with our Keurig business, we're seeking a visionary Senior Director to lead our Sarbanes-Oxley (SOX) Program Management Office (PMO). This high-impact role will be pivotal as we separate into two independent, U.S.-listed, publicly traded companies: a Global Coffee Company and a Beverage Company.
Responsibilities:
Design and Execute Global SOX Strategy: Build and deliver a comprehensive SOX compliance roadmap for IPO readiness and beyond. Own the project plan for SOX 302 and 404 compliance, ensuring effective, efficient, and timely execution worldwide.
Lead Internal Controls: Oversee the design, documentation, and testing of internal controls over financial reporting (ICFR) across all major business units for the future Global Coffee Company. Be the subject matter expert guiding process owners and continuously enhancing our control environment.
Drive Risk Assessment & Remediation: Lead enterprise-wide risk assessments, identify control gaps, and collaborate with management to drive timely remediation.
Collaborate Across Functions: Partner with Finance, Accounting, IT, Operations, and more to embed strong controls into new and existing systems and processes. Foster a culture of compliance and partnership.
Engage with Audit Committee & External Auditors: Serve as the primary liaison for SOX and internal controls matters for the future Global Coffee Company. Prepare updates for senior executives and the Board and maximize efficiency in audit processes.
Build and Mentor Teams: Develop a high-performance SOX compliance team, instilling best practices and leveraging modern audit tools and data analytics.
Champion Continuous Improvement: Stay ahead of regulatory changes and best practices. Seek opportunities to automate and streamline controls, testing, and provide strategic input during major initiatives.
This is a rare opportunity to leave your mark by building a world-class SOX and internal audit function from the ground up. You'll help shape the financial governance of a dynamic, global organization as it enters the public markets, instilling investor confidence and driving long-term success.
If you're a proven leader in audit and compliance, ready to make a significant impact, we encourage you to apply and join us in shaping a foundation of integrity, transparency, and excellence.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Total Rewards:
Salary Range: $183,500 - $242,000
Actual placement within the compensation range may vary depending on experience, skills, and other factors
Benefits, subject to election and eligibility: Medical, Dental, Vision, Disability, Paid Time Off (including paid parental leave, vacation, and sick time), 401k with company match, Tuition Reimbursement, and Mileage Reimbursement
Annual bonus based on performance and eligibility
Requirements:
Education & Certifications: Bachelor's in Accounting, Finance, or related field. CPA and/or CIA required; MBA or Master's a plus.
Experience: 10+ years in external/internal audit, with 5+ years in SOX or audit leadership. Big Four or equivalent audit consulting experience required. Proven track record in SOX 302 and 404 program design and implementation.
Technical Expertise: Deep knowledge of SOX (Sections 302 & 404), COSO, PCAOB standards, and US GAAP. Skilled in evaluating business processes and IT general controls.
Leadership & Communication: Exceptional ability to lead and influence cross-functional teams at all levels and communicate complex issues clearly. Experience presenting to Audit Committees or executive boards.
Team Building: Demonstrated success in building highly engaged, collaborative teams and fostering a culture of continuous improvement.
Language: Fluency in English (written and spoken) required.
Preferred: Experience in consumer products/manufacturing, IPO readiness, global operations, and additional certifications (e.g., CISA, CFE, etc.). Familiarity with GRC tools and data analytics in auditing is a plus.
Company Overview:
Keurig Dr Pepper (NASDAQ: KDP) is a leading beverage company in North America, with a portfolio of more than 125 owned, licensed and partner brands and powerful distribution capabilities to provide a beverage for every need, anytime, anywhere. We operate with a differentiated business model and world-class brand portfolio, powered by a talented and engaged team that is anchored in our values. We work with big, exciting beverage brands and the #1 single-serve coffee brewing system in North America at KDP, and we have fun doing it!
Together, we have built a leading beverage company in North America offering hot and cold beverages together at scale. Whatever your area of expertise, at KDP you can be a part of a team that's proud of its brands, partnerships, innovation, and growth. Will you join us?
We strive to be an employer of choice, providing a culture and opportunities that empower our team of ~29,000 employees to grow and develop. We offer robust benefits to support your health and wellness as well as your personal and financial well-being. We also provide employee programs designed to enhance your professional growth and development, while ensuring you feel valued, inspired and appreciated at work.
Keurig Dr Pepper is an equal opportunity employer and recruits qualified applicants and advances in employment its employees without regard to race, color, religion, gender, sexual orientation, gender identity, gender expression, age, disability or association with a person with a disability, medical condition, genetic information, ethnic or national origin, marital status, veteran status, or any other status protected by law.
A.I. Disclosure:
KDP uses artificial intelligence to assist with initial resume screening and candidate matching. This technology helps us efficiently identify candidates whose qualifications align with our open roles. If you prefer not to have your application processed using artificial intelligence, you may opt out by emailing your resume and qualifications directly to **************** in lieu of clicking Apply. Please include the job title and location or Job ID # in the email subject line.
$183.5k-242k yearly 2d ago
Chief Operating Officer
Dumpling Daughter 3.6
Associate director job in Weston, MA
📍 Boston Metro | 🕒 Full-Time, In-Person, Remote, or Hybrid
Key Responsibilities & KPIs
1. Strategic & Operational Leadership
Responsibilities:
Partner with the CEO to define and execute Dumpling Daughter's 3-year growth plan and operational roadmap.
Translate strategic goals into actionable, measurable plans with clear ownership, budgets, and KPIs.
Drive continuous improvement, speed, and cost efficiency across all areas of the business.
Lead monthly operations reviews and OKR tracking.
KPIs:
Achievement of annual growth and profitability targets
% of strategic initiatives delivered on time and on budget
Employee engagement >85%
2. Supply Chain & Production Management
Responsibilities:
Oversee sourcing, procurement, and co-manufacturing for dumplings and sauces.
Manage relationships with co-packers, ingredient suppliers, and cold storage partners.
Ensure food safety, quality assurance, and regulatory compliance (USDA, FDA).
Implement production planning to meet demand across retail, restaurant, and DTC channels.
KPIs:
Cost of Goods Sold (COGS) % improvement YoY
On-time, in-full (OTIF) deliveries ≥ 95%
Production yield > 98%
Quality incident rate < 0.5% of total units
3. Logistics, Fulfillment & Distribution
Responsibilities:
Lead cold chain logistics, inventory management, and fulfillment operations.
Manage third-party logistics (3PLs) for retail and e-commerce distribution.
Optimize warehouse operations to balance inventory turns and freshness.
Build reliable, scalable systems for regional and national distribution.
KPIs:
Fulfillment accuracy ≥ 99%
Inventory turnover 8-10x per year
Freight cost per unit (target reduction YoY)
Average delivery time (target improvement YoY)
4. Commercial Operations & Launch Readiness
Responsibilities:
Partner with Sales and Marketing to operationalize product launches and new retail expansion.
Ensure production, packaging, and logistics readiness for new SKUs or new channels.
Collaborate on demand forecasting, pricing, and inventory optimization.
Support expansion into new regions, retailers, and foodservice partners.
KPIs:
Product launch on-time rate ≥ 95%
Forecast accuracy ≥ 85%
Out-of-stock rate < 3% across SKUs
Gross margin improvement YoY
5. Financial & Performance Management
Responsibilities:
Build and manage annual operating budget; drive cost discipline and operational efficiency.
Partner with Finance to manage working capital, cash flow, and inventory economics.
Monitor key metrics through dashboards and operational reporting.
Identify and execute cost reduction and margin improvement initiatives.
KPIs:
Gross margin % (target improvement YoY)
EBITDA margin growth YoY
Cash conversion cycle improvement
Operational expense ratio (OpEx as % of revenue)
6. Team Leadership & Culture
Responsibilities:
Build and lead a high-performing operations team spanning supply chain, QA, and logistics.
Hire, coach, and develop talent; establish clear accountability and growth paths.
Reinforce Dumpling Daughter's culture of quality, authenticity, and teamwork.
Champion diversity, inclusion, and a positive, collaborative environment.
KPIs:
Team retention ≥ 90%
Employee engagement ≥ 85%
Leadership succession & internal promotion rate ≥ 20%
7. Systems, Compliance & Continuous Improvement
Responsibilities:
Implement systems (ERP/MRP, inventory, QA) to scale operations and improve visibility.
Ensure full compliance with all regulatory, labeling, and food safety requirements.
Drive automation, process simplification, and waste reduction.
Lead sustainability and responsible sourcing initiatives.
KPIs:
Audit/compliance success rate 100%
Reduction in manual processes ≥ 20% YoY
Waste reduction % of output
ERP utilization rate ≥ 90%
Qualifications
10+ years of experience in food manufacturing, CPG, or FMCG operations, ideally including frozen or refrigerated foods.
Proven success scaling supply chain and production in a high-growth food brand.
Experience managing co-packers, 3PLs, and cold chain logistics.
Deep understanding of food safety, quality, and compliance (FDA/USDA).
Strong financial and analytical skills; P&L ownership preferred.
Entrepreneurial mindset, hands-on leadership style, and collaborative approach.
Bachelor's degree required; MBA or equivalent experience preferred.
Why Join Dumpling Daughter
Join a beloved, mission-driven food brand entering its next phase of national growth.
Opportunity to build systems, teams, and scale from the ground up.
Competitive compensation, including equity participation.
Be part of a company that blends family values, cultural authenticity, and commercial ambition.
How to Apply: Send your resume and a cover letter to ****************************
$143k-220k yearly est. 3d ago
Associate Director Regulatory Affairs
EPM Scientific 3.9
Associate director job in Boston, MA
Title: AssociateDirector of Regulatory Strategy
A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented AssociateDirector of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development.
Key Responsibilities
Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning.
Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters.
Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor.
Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements.
Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities.
Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation.
Qualifications
Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development.
Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies).
Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA).
Familiarity with 505(b)(2) development strategies or innovative delivery platforms.
Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas.
Proven track record of successful interactions with the FDA and/or global regulatory agencies.
Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies.
Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.
$112k-169k yearly est. 5d ago
Associate Director/ Director of Drug Safety/ PV
Vivid Resourcing
Associate director job in Boston, MA
Reports to: Senior Director Pharmacovigilance
Department: Pharmacovigilance / Drug Safety
The Director of Pharmacovigilance will lead and oversee all aspects of post-marketing and clinical safety surveillance activities, ensuring compliance with global regulatory requirements, best practices, and company policies. This role entails strategic planning, maintenance and continuous improvement of the pharmacovigilance system (PVS), oversight of risk management, signal detection, safety reporting, and communication with health authorities.
The incumbent will work closely with clinical development, regulatory affairs, quality, medical affairs, and manufacturing to ensure safety is integrated through the lifecycle of the company's pipeline.
Qualifications / Skills
Qualified MD
Minimum of 10 years of experience in pharmacovigilance / drug safety in the biotech / pharma industry, with at least 3-5 years in a leadership role.
Strong extensive experience in Oncology.
Strong knowledge of global regulatory requirements in pharmacovigilance: FDA, EMA, ICH, MHRA, etc.; good understanding of local country requirements in key markets (Japan, China, etc.) is a plus.
Experience developing and overseeing Risk Management Plans, RMP / PSUR / DSUR preparation, signal detection & management.
Proven track record of handling inspections / audits by regulatory authorities related to PV.
Excellent analytical skills, ability to interpret safety data, derive insights, summarize for multiple audiences (scientific, regulatory, executive).
Leadership & communication skills: able to lead a team, collaborate cross-functionally, influence senior management.
Proficiency in use of safety databases, electronic reporting systems, signal detection tools, safety-oriented metrics dashboards.
What We Offer
Competitive compensation package including base salary, performance bonus, equity / share options.
Strong cross-functional exposure (clinical, regulatory, CMC, medical affairs).
Professional development and potential for upward career growth.
Impact in shaping regulatory strategy and ensuring patient safety on a global scale.
$100k-147k yearly est. 4d ago
Associate Director Regulatory Affairs
Codon Partners
Associate director job in Boston, MA
Our client is seeking an experienced AssociateDirector of Regulatory Affairs to lead clinical regulatory strategy for a portfolio of small-molecule drug programs progressing from late clinical development through NDA submission and approval. This role is highly strategic and cross functional, serving as the regulatory lead for clinical development planning, FDA engagement, and NDA execution. The successful candidate will be deeply embedded in clinical development, partnering closely with Clinical Development, Clinical Operations, Biostatistics, Medical Affairs, and Commercial teams.
The Director of Regulatory Affairs will be responsible for leading the clinical regulatory strategy for small-molecule programs, ensuring alignment between regulatory strategy, clinical execution, and commercial objectives.
Responsibilities
Develop and own the global clinical regulatory strategy for small-molecule programs from IND through NDA submission and approval.
Provide regulatory leadership on clinical development plans, study designs, endpoints, and protocol strategy to support approvability.
Ensure alignment between regulatory strategy, clinical execution, and commercial objectives.
Serve as the primary regulatory lead for FDA interactions, including End-of-Phase 2 meetings and Pre-NDA meetings
Advisory Committee preparation (as applicable)
Prepare and lead briefing packages, meeting requests, responses to FDA questions, and follow-up commitments.
Labelling strategy and negotiations and risk-benefit assessments
Partner with Regulatory Operations to ensure timely, high-quality NDA submissions.
Act as the regulatory voice on clinical development teams, providing real-time regulatory guidance and risk assessment.
Monitor evolving FDA guidance and regulatory precedents relevant to small-molecule NDAs.
Identify regulatory risks early and propose mitigation strategies.
Contribute to long-range regulatory planning and portfolio prioritization.
Qualifications
Bachelor's degree in Life Sciences or related field (advanced degree preferred).
6 - 10 years of Regulatory Affairs experience with a strong emphasis on clinical regulatory strategy.
Demonstrated leadership of IND-to-NDA pathways for small-molecule drugs.
Experience in FDA meetings and influencing clinical development decisions.
Proven ability to work cross-functionally and influence senior stakeholders.
Prior experience leading or contributing to successful NDA approvals.
Experience in fast-paced biotech or pharmaceutical environments.
Familiarity with global regulatory considerations (EMA, MHRA) is a plus but not required.
If interested, please Easy Apply below or reach out to ********************************
$100k-147k yearly est. 3d ago
Associate Director
Prokatchers LLC
Associate director job in Cambridge, MA
The AssociateDirector, Scientific Communications Lead, Hematology is a senior role focused on developing and executing strategic publication and scientific communication plans for oncology assets, ensuring alignment with medical strategies, compliance, and data transparency.
Core Responsibilities
Leads cross-functional teams in creating global publication plans, managing scientific deliverables like manuscripts, slide decks, and digital content, while overseeing vendors, budgets, and databases such as Datavision. Serves as liaison with opinion leaders, authors, and partners; develops scientific platforms; and provides training on best practices like GPP3 and ICMJE guidelines.
Qualifications
Requires an advanced degree (PhD/PharmD preferred) in life sciences, 5+ years in medical publications within pharma/biotech (oncology preferred), Bachelors is acceptable. strong project management, analytical skills, and proficiency in tools like MS Office and SharePoin
$100k-147k yearly est. 4d ago
Director System Patient Financial Services
Cape Cod Healthcare 4.6
Associate director job in Barnstable Town, MA
PURPOSE OF POSITION: Develops and executes the strategic vision for Patient Financial Services (“PFS”) functions across all Cape Cod Healthcare ("CCHC") entities. Provides leadership and oversight of key operational and financial decisions pertaining to all insurance and patient Accounts Receivable (“AR”) resolution, denials management, customer service and billing compliance. Coordinates with the VP of Revenue Cycle and/or CFO to develop yearly metrics and is responsible for managing people and processes to achieve or exceed CCHC's revenue cycle goals and performance metrics expectations. Has responsibility to timely budget submission and ongoing management to budget expectations. Leads or serves on CCH revenue cycle process improvement task forces and committees.
PRIMARY DUTIES AND RESPONSIBILITIES:
Directs the performance of CCHC Patient Financial Services Accounts Receivable (AR) including but not limited to Billing, Insurance Follow-Up, Customer Service, Denials Prevention and Management and Vendor Management.
Responsible for hiring, coaching, and otherwise developing direct reports and creating or ensuring creation of a structure for employee onboarding and ongoing development.
Collaborates with the CFO and VP of PFS & Revenue Cycle to set goals, identify opportunities to improve AR resolution, resulting in payment based on industry Key Performance Indicators (“KPIs”) for Patient Financial Services and Revenue Cycle.
Responsible for measurement and reporting of ongoing financial and operational performance. Ensure the implementation of action plans where performance is not meeting expectations and recognizing areas of excellence.
Lead the implementation of best practice strategies to increase cash flow and turnaround time in account resolution.
Demonstrates a commitment to exceptional customer satisfaction to all parties. Appropriately assesses who our customers are (e.g. anyone the individual has a responsibility to serve inside and/or outside the Health System). Conducts self in a polite, forthright manner, articulately communicating with others and using discretion, judgment, common sense and timeliness in customer service decision -making.
Create, monitor and perform within established budgets.
Develop, implement, and manage efficient and effective operational policies, procedures, processes and performance monitoring across all Patient Financial Services functions. Ensure that all PFS employees and process owners are held accountable and are meeting established standards and goals.
Ensure PFS employees across all functions are trained and comply with established policies, processes, and quality assurance programs.
Identify potential process improvements through Patient Financial Services, and lead the design and implementation as required.
Coordinate and oversee all third party AR and payment application process transition points between Patient Financial Services and other functional areas within the revenue cycle organization.
Monitor and facilitate service level agreements (“SLAs”) between Patient Financial Services and other related functions, within both Revenue Cycle and Clinical Operations as necessary.
Coordinate with peers across the Revenue Cycle organization, and with related stakeholders, on the management of third-party denials by working with the onsite Revenue Cycle Integration leaders, Patient Access Services and middle Revenue Cycle functions, Professional Revenue Cycle, Home Health and Hospice, and Behavioral Health to identify trends and implement denials prevention and/or recovery programs.
Routinely conduct payer trend analysis to ensure optimal processing and reimbursement, identify issues, communicate findings to CCHC PFS stakeholders, define solutions and initiate resolution.
Coordinate with peers across the Revenue Cycle organization on the management of PFS edits by working with the Unbilled Committee to identify trends and implement modifications to workflow to limit pre-billing edits.
Build strong relationships and facilitate productive communication between key revenue cycle stakeholders, including peer leaders of Revenue Cycle services and core support departments (e.g., Human Resources, IT, Finance, Managed Care, etc.)
Develop and maintain effective payer working relationships.
Assess direct reports' performance on a consistent basis and provides feedback to reward effective performance and enable proactive performance improvement steps to be taken.
Consistently provides service excellence to all patients, family members, visitors, volunteers and co-workers.
Challenges current working practices; identifies process improvement opportunities and presents recommendations and solutions to management. Engages and commits to the organization's culture of continuous improvement by actively participating, supporting, and promoting CCHC Pillars of Excellence.
EDUCATION/EXPERIENCE/TRAINING:
Bachelor's degree in Business Administration, Healthcare Management or related discipline preferred or the equivalent combination of education and experience.
Minimum of five to seven years of relevant experience with a track record of progressively responsible positions in a complex healthcare organization such as a multi-hospital system, large group practice or a major healthcare consulting firm preferred.
Minimum of three to five years of supervisory/management experience. Prior experience in a union environment preferred.
Strong technical grounding, project management and implementation experience required. Proven leadership abilities and comprehensive knowledge of healthcare information systems. Epic Single Business Office (SBO) and clearinghouse experience preferred.
Strong working knowledge of regulatory requirements, payer requirements, billing coding requirements (ICD, CPT, HCPCs, etc.), general revenue cycle management strategies, and industry best practices.
Thorough knowledge of metrics, analytics, and data synthesis in healthcare patient financial services and revenue cycle management to identify trends, produce reliable forecasts and projections.
Strong analytical and critical thinking, organizational, and business process optimization skills, with in-depth ability to develop and pursue goals, synthesize data to identify system vulnerabilities and develop and apply innovative solutions.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
An understanding of the psychology of complex corporate relationships, and an ability to influence within such an environment.
Excellent communication and organizational skills are required, with the ability to effectively communicate to physicians, patients, staff, payers and administration. Above average understanding of how, when, and to what extent different hospital departments relate to and communicate with one another.
Pay Range Details:
The pay range displayed on each job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set, and education. This is not inclusive of the value of Cape Cod Healthcare's benefits package (if applicable), which includes among other benefits, healthcare/dental/vision and retirement. For annual salaries this is based on full-time employment.
$212k-293k yearly est. 3d ago
Vice President of Operations-Luxury Short Term Rentals
Talently
Associate director job in Boston, MA
Job Title: Executive Vice President of Operations
Salary: $150,000-$165,000 + BONUS
Skills: Short Term Rental Experience, Willingness to Travel, Abscence of Ego, Super Process Driven, PropCo, OpCo
About the Hospitality Company / The Opportunity:
Step into a high-impact executive leadership role with a dynamic company at the forefront of the hospitality industry. Specializing in luxury short-term rentals and group travel experiences across premier destinations, this organization combines the warmth of hospitality with innovative, data-driven operational strategies. This opportunity offers you the chance to architect and scale sophisticated operational systems, make significant P&L improvements, and help redefine the standards for group accommodation-all while leading a geographically distributed, high-performing team in a rapidly growing sector.
Responsibilities:
Shape and execute operational strategy across all business divisions, including property operations, company operations, new property installations, and procurement.
Architect scalable processes and systems that optimize operational efficiency and drive measurable improvements in profitability across multiple markets.
Oversee and develop regional and functional leaders while cultivating a culture of operational excellence within both PropCo and OpCo entities.
Lead centralized purchasing and supply chain functions to ensure cost-effective procurement and strong vendor relationships nationally.
Manage budgets, oversee P&L performance, and implement effective cost control strategies to ensure sustainable growth.
Champion speed-to-market initiatives and process improvements to support company expansion in new and existing markets.
Preserve high guest experience standards and brand consistency across all properties and operational activities.
Travel up to 25-30% to key markets and properties, providing executive oversight and leadership presence.
Must-Have Skills:
10+ years of operations leadership, with at least 5 years at the executive or senior level in hospitality, property management, or real estate operations.
Proven experience designing and implementing operational systems in multi-market environments.
Strong expertise in P&L management, budget development, and rigorous cost control.
Successful track record leading large, multi-disciplinary teams and managing large-scale organizational change.
Bachelor's degree required; MBA or equivalent leadership training strongly preferred.
Background in centralized purchasing, procurement, or supply chain management across diverse vendors.
Outstanding interpersonal and written communication skills, with the ability to influence executive stakeholders.
Willingness and ability to travel up to 25-30% nationally.
Nice-to-Have Skills:
Specific experience in luxury short-term rental or group hospitality operations.
Strong familiarity with both PropCo and OpCo business models and operations.
MBA or advanced degree in a relevant field.
Technological fluency, including experience with hospitality tech platforms and data-driven decision making.
Abscence of ego and a collaborative, team-focused leadership style.
Demonstrated ability to thrive in a fast-paced, scaling environment.
$131k-215k yearly est. 4d ago
Senior Director, Healthcare Compliance
Larson Maddox
Associate director job in Boston, MA
We are partnered with a commercial-stage Biopharmaceutical company who is looking to bring on a Compliance Business Partner at the Senior Director level. This position offers a unique opportunity to shape compliance strategy within a dynamic, growth-oriented environment, partnering closely with senior leadership and stakeholders.
Key Responsibilities:
Oversee and manage day-to-day commercialization efforts while ensuring adherence to applicable laws, regulations, and industry standards.
Develop, implement, and maintain compliance policies, procedures, and training programs to guide organizational operations.
Serve as the primary compliance advisor for business teams, providing risk identification and mitigation strategies for initiatives involving healthcare professionals, patients, and advocacy groups.
Provide compliance oversight for programs such as speaker engagements, sponsorships, grants, and other healthcare-related interactions.
Support transparency reporting, drug price reporting, internal investigations, and access to compliance tools including risk assessments and vendor due diligence.
Qualifications:
8+ years of pharmaceutical compliance, audit, or related experience; B.A./B.S. required, advanced degree (MBA/JD) preferred.
Strong knowledge of U.S. and global compliance laws, including anti-kickback statutes, transparency reporting, and industry guidelines (OIG, PhRMA).
Experience with compliance audits, monitoring, and global transparency reporting; CHC or PMP certification is a plus.
$131k-192k yearly est. 3d ago
Director/Senior Director,CMC lead
WuXi XDC
Associate director job in Boston, MA
WuXi XDC (stock code: 2268.HK), a leading Contract Research, Development and Manufacturing Organization (CRDMO) focused on the global antibody drug conjugates (ADCs) and broader bioconjugate market, is a pioneering CRDMO offering integrated, end-to-end services. Services are provided from proximately located, state-of-the-art laboratories and manufacturing facilities, allowing for a significant reduction in development timelines and costs. Headquarter in Shanghai, China, our over 1,000 skilled employees work across a global network to deliver expert-driven, high-quality and right-first-time project execution for our customers. By offering a single-source, open-access platform with the most comprehensive capabilities and technologies, WuXi XDC enables our biopharmaceutical partners to speed the development of innovative therapies for the benefit of patients worldwide.
About the job
Summary:
The incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting WuXi XDC's services at conferences/trade shows.
This position will offer the candidate flexibility working remotely from home in US or EU locations. Relocation to China could be an option.
Responsibilities:
Provide project and portfolio leadership supporting IND-enabling early and late stage bioproduct development CMC activities.
Collaborate with CMC functional areas to ensure successful execution of various ADC or bioconjugate CMC projects, and delivery of results on time and within budget.
Assist with development and manufacturing alliance management, product development and manufacturing strategy.
Coordinate efforts and facilitate communication to ensure alignment between WuXi XDC and clients.
Work with a high-performance team to ensure best quality services.
Enhance current service offering and develop new clients.
Technical Skills /Knowledge:
The candidate should possess strong and effective project management, problem solving and interpersonal skills, and have a proven track record of working cross-functionally, across a wide variety of technical, business, and operational areas.
Demonstrate good understanding of the pharmaceutical industry and large molecule drug development.
The title of this CMC Lead position is flexible and may be from AssociateDirector, Director up to Senior Director.
Depending upon the title, minimal 5-20 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing is required.
Working knowledge and understanding of current regulations and industry trends for large molecule and ADC/bioconjugate product development, manufacture, and testing is a must.
Working experience in ADC is preferred.
Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.
Customary Education and Experience:
MS/PhD in biochemistry, molecular biology, biochemical engineering, pharmaceutical science or related discipline.
Fluent in English and Mandarin Chinese.
Must have working knowledge of MS Office products.
Technical experience at large pharma or biotech companies.
ADC/Biologics process/formulation/analytical development and/or manufacturing experience
$131k-192k yearly est. 3d ago
Vice President- Debt Capital Markets
Davis 3.8
Associate director job in Boston, MA
Davis is a vertically integrated real estate investment, development and management firm that leverages five decades of experience, the strength of its leadership team and employees and a diversified portfolio to deliver maximum value for its investors and tenants. Headquartered in Boston and investing across the United States, Davis prides itself on taking a nimble, collaborative approach to delivering best-in-class results from complex opportunities. With $12.8 billion in gross asset value invested through real estate equity, debt and fixed-income securities, Davis today owns a real estate portfolio of approximately 15.2 million square feet of healthcare and life science, industrial, retail, office and hospitality properties and more than 5,800 residential units across the United States. For further information, visit **************************
This position will be dedicated to sourcing, structuring, closing, and managing project level debt financing for the Company's commercial real estate portfolio. Additionally, this position will assist the CFO with sourcing, negotiating and closing fund level subscription lines of credit, managing interest rate risk across the portfolio and conducting ad hoc projects. Types of financing include acquisition, construction, and permanent loans, but could also include subscription lines of credit, warehouse lines of credit and note on note financing.
This individual will work to enhance the ecosystem of our credit relationships to capitalize on our robust pipeline of development projects and value-added investments, often working through innovative transaction structures to secure the best economics for the company. The Vice President, Debt Capital Markets will also partner internally with the investments team to source loan acquisitions and work with the asset management, development, accounting, legal, and risk teams on revenue forecasting, strategy, business planning, and operational requirements.
Role & Responsibilities:
Capital Markets Strategy & Execution
· Develop and execute firm-wide debt capital markets strategy in alignment with investment and portfolio objectives.
· Lead the structuring, sourcing, negotiation, and closing of complex real estate financings across asset classes and geographies.
· Oversee preparation of financing packages, including cash flow modeling and sensitivity analysis, lender outreach, term sheet negotiation, and final execution.
· Manage portfolio-wide debt maturity schedules and refinancing strategies on a multi-year horizon.
· Execute loan on-boarding, including but not limited to loan abstracting of reporting due dates, covenant test dates, compliance forms and leading debt investment turnover meetings.
· Work collaboratively with investment and asset management teams in sourcing and managing debt investments of the flagship value-add equity fund and credit fund, which may include leading the asset management of existing debt investments.
Lender & Capital Partner Relationships
· Own and cultivate senior-level relationships with banks, insurance companies, agencies, and alternative lenders.
· Represent Davis in capital markets discussions, lender strategy meetings, and industry forums, including but not limited to CREFC and MBA.
· Lead lender selection strategy for large-scale, complex, or non-traditional financings.
Portfolio & Risk Management
· Advise senior management on optimal capital structure, leverage, interest rate exposure, and recourse considerations.
· Lead the formation of debt diversification initiatives and hedging strategies and make recommendations to the hedging sub-committee.
· Oversee covenant compliance, reporting requirements, and lender communication across the loan portfolio.
· Manage and execute post-closing loan amendments, extensions, etc., working in conjunction with the asset management, legal and accounting teams.
Leadership & Cross-Functional Collaboration
· Serve as a senior capital markets resource across investment, development, asset management, legal, and accounting teams.
· Lead cross-functional teams on complex financings, recapitalizations, and restructurings.
· Act as a trusted advisor to executive management on all matters of finance and debt capital markets.
Analytical & Advisory Responsibilities
· Lead tenant credit financial analysis and other ad hoc financial analysis as required.
· Provide market intelligence and insights on lending trends, pricing, and new capital sources to senior leadership.
· Contribute to Investment Committee and executive level presentations to guide business strategy decisioning and reporting.
· Participate in investment, valuation, and risk management processes, including but not limited to weekly investment committee meetings as required.
· Participate in Vertical meetings, providing support and collaboration with the Vertical Leads as required from a debt optimization and execution perspective.
· Other responsibilities and requirements as required by manager or company.
Skills & Qualifications:
· Bachelor's degree required, MBA/ M.S. or other relevant Advanced Degree preferred.
· A minimum of ten (10) years of commercial real estate investment and finance experience, preferably working with properties in excess of $25mm in value across multiple asset types including lab/life science, office, residential and industrial.
· Demonstrated ability to creatively structure complex loan structures and to close high volume of financing transactions.
· Must be an incredibly driven self-starter with exceptional time management, presentation and communication skills.
· Experience underwriting and valuing commercial real estate investments using discounted cash flow, direct capitalization, and sale comparable methodologies.
· Demonstrate strong organizational skills, including commitment to follow-up on open issues, meet deadlines and pay attention to details.
· Flexibility to deal with multiple projects simultaneously while working independently.
· Knowledge of and interest in U.S. capital markets.
Compensation & Benefits:
Salary Range: $175,000 - $250,000
Compensation will include a bonus and an attractive benefits package.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), national origin, age (40 or older), marital status, sexual orientation, gender identity/expression, citizenship, real or perceived disability or handicap, genetic predisposition, veteran status, and/or any other protected category in accordance with applicable federal, state or local law
$175k-250k yearly 1d ago
Director, CMC Project Leadership
Fusion Pharmaceuticals
Associate director job in Boston, MA
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
Fusion Pharmaceutical is opening a role for a Director, CMC Project Leadership. Reporting to the Vice President of Manufacturing, this individual will be responsible for leading CMC efforts for our lead asset, FPI-2265 and representing CMC on the Global Program team.
This high visibility position requires excellent communication skills, multi-tasking ability, and desire to strive in a fast-paced environment. The successful candidate will bring a strong background in CMC and Project leadership.
This position is based out of our Boston, MA office and will follow a hybrid work schedule.
Responsibilities:
Has overall accountabilìty for defining and delivering the pharmaceutical development strategy that delivers effective development, approval, commercialization and LCM of new medicines.
The key CMC accountabilities include
The overall development and technical strategy
The regulatory strategy and documentation for marketing authorizations (incl IND/IMPD)
For in-market products, the role holder is accountable for the development and delivery of the Manufacturability Strategy & Plan.
Clinical supply chain strategy and plan for Phase 3 (transferred generally at start of Phase 3)
Accountable to the Global Program Team (GPT) for maintaining and delivering all aspects of the pharmaceutical development plan including control of the scope, timing, resources, cost, quality and risk.
An active member of the GPT, contributing to the development of overall project strategies. Is expected to have credibility and influence within the team in which the role holder is a member.
Accountable for the technical development strategy for APl, DP & Analytical aligned with project strategy and priority.
The role involves a diverse range of problems/opportunities requiring complex judgements and solutions based on highly developed levels of conceptual thought and strategic vision and analysis.
May represent CMC on the evaluation of business development opportunities .
Has the responsibility to ensure that project strategies are reviewed
Skills and Qualifications:
10+ years experience in product development and manufacturing; Advanced degree in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline preferred. PMP certification a plus
Demonstrated strong leadership with enterprise mindset, learning agility, networking and negotiation skills and collaborative approach supportive of delivery of business objectives.
Demonstrated strong interpersonal and communication skills with ability to set clear direction and objectives for the team and to influence at a senior level in the organization including Governance groups
Capable of managing the responsibilities for a diverse range of activities and projects acting as the key sponsor for projects and programs supporting their project portfolio.
Excellent negotiation and influencing skills in order to influence and contribute to the cross-functional project/product strategies and deliverables
Possess strength and independence of viewpoint and be willing to challenge others in senior roles in other parts of Global Operations and the rest of the business when appropriate
Ability to develop & implement end-to-end Pharmaceutical strategy across all CMC areas (APl, DP, etc.) aligned with the overall GPT strategy and clinical/commercial supply
Significant experience of leading multi-disciplinary teams with an ability to ensure correct structure and team composition for efficient delivery and transition across the value stream
Strong coaching and motivational leadership skills that support the development of and delivery through the Pharmaceutical Team
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
The annual base pay for this position ranges from $162,682.40 to $244,023.60. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
$76k-116k yearly est. 3d ago
Executive Director of Labor Relations and Employee Services
Providence Public Schools 3.4
Associate director job in Providence, RI
Reporting to the Chief Talent Officer, the Executive Director of Labor Relations and Employee Services oversees two key teams within the department of Human Resources. Position oversees a team to support the Chief Talent Officer with day-to-day management of labor relations and employment issues, ensuring District compliance with applicable local, state and federal laws and regulations. In addition, the position will communicate policy decisions, ensure a high-level of customer service from the team, and set goals and benchmarks with the team. The Executive Director will also communicate regularly with General Counsel and serve as a member of the Human Resources senior leadership team.
***Contingent upon funding***
EDUCATION TRAINING AND EXPERIENCE
Bachelor's degree in labor relations, human resources management, business, or public administration or related field
MINIMUM QUALIFICATIONS STANDARDS
Five (5) or more years of successful experience in labor and contract negotiations for a large school system or comparable governmental entity
Two (2) years of experience in a position requiring investigation of employee relations issues
Extensive knowledge of labor and employment laws and regulations. SHRM-certified professional (PHR) or Senior Professional (SPHR) preferred
Thorough understanding of human resources principles and practices
Experience in grievance procedure arbitration
Demonstrated ability to exercise sound judgment and maintain consistency in decisions
Demonstrated ability to effectively communicate, both orally and in writing. Must be able to prepare comprehensive reports and represent ideas clearly and concisely
Demonstrated ability to build and maintain relationships across diverse groups, including schools, departments, labor unions/associations and community/business partners
Full job description and list of duties/responsibilities at: ********************************************************
$125k-187k yearly est. 5d ago
Senior Director - External Investment Management - Real Assets
FM 3.9
Associate director job in Waltham, MA
FM is a leading property insurer of the world's largest businesses, providing more than one-third of FORTUNE 1000-size companies with engineering-based risk management and property insurance solutions. FM helps clients maintain continuity in their business operations by drawing upon state-of-the-art loss-prevention engineering and research; risk management skills and support services; tailored risk transfer capabilities; and superior financial strength. To do so, we rely on a dynamic, culturally diverse group of employees, working in more than 100 countries, in a variety of challenging roles.
This is a senior role, reporting to VP - Private Alternative Investments and working closely with Senior PM - External Investment Management, direct real estate investment team, the Chief Investment Officer (CIO), and other senior Investments leaders and staff, across asset classes, with a primary focus on real assets investments with our external investment management partners. This role will work closely with other Public and Private Markets sector PMs and/or PM's, the Asset Allocation, Strategy group, and Investment Operations. This key role will also collaborate in helping manage broad and/or specific aspects of portfolio construction related to the external mandates in real assets, including infrastructure and real estate. Responsibilities will also include relevant collaboration on risk and performance analytics across private markets. The incumbent will also be supporting periodic investments, economic and financial markets-related projects and initiatives related to asset allocation activities, and also necessitate collaboration with internally managed portfolio management leadership as well.
The role's focus will primarily be private markets investments across real assets, those are managed by our external investment management partners. The externally managed real assets portfolio has investments across a very wide range of styles and strategies. The role is expected to be very proficient with concepts including but not limited to private real assets including real estate and infrastructure and private equity including distressed, special situations strategies. While private markets will be the primary focus of this role, a good understanding of multi asset public and private investing is key to succeed in this role.
The role requires experience in constructing portfolios with private markets investment products with a strong understanding of the objectives of the overall investment process. The role will be responsible for performance across external real assets mandates, serve as an interface for the investment team with the external investment managers. This includes researching new investments, new and existing manager diligence and underwriting, allocation or reallocation decisions, communication to and from managers, monitoring performance and risk of the portfolio. The role will also bring in best practices, macro-economic and market outlook to the broader portfolio. The role will closely work with investment operations, legal, tax and other support functions to ensure a seamless management of the external real assets portfolio.
• Externally managed private real assets portfolio construction
• Work with portfolio management leadership and CIO to build and develop strategy
• Work with Asset Allocation to define focus areas for strategy selection, manager diligence
• Monitor current portfolio and strategies to determine if they are designed optimally
• External Manager, General Partner (GP) diligence, selection and underwriting and monitoring
• Build and maintain relationships with existing and new investment management partners
• Have periodical portfolio review meetings, calls to stay updated on performance and it's drivers, risk, views and positioning
• Explain drivers of performance to investment leadership
• Recommend portfolio actions
• Special strategic investments, co-investments and portfolio companies related investments
• Collaborate with performance analytics for better return and attribution reporting
• Collaborate on portfolio construction, investments monitoring, and risk management across asset classes within the overall total portfolio construction framework
• Share insights from external real assets markets managers relevant to the total portfolio
• Work closely with other senior investments leads on periodic, ad-hoc, and special research projects
BA or BS required; MBA, CFA, CAIA or other advanced degree related to investments, economics, finance, or quantitative analysis preferred
8+ years of relevant experience in investments, financial markets and/or financial risk management
8+ years of global financial market experience across asset classes
Global financial markets, investments, risk management and economics related experience across asset classes, and risk and quantitative analysis·
Broad knowledge in the financial markets and investments across asset classes·
Strong inter-personal, communication, presentation, analytical and collaboration skills·
Experience collaborating with other internal stakeholders and partners - investment accounting, legal, tax and other departments·
Ability to operate as an effective tactical as well as strategic thinker with flexibility to adapt to and positively influence new processes/infrastructure·
Strong mentoring and coaching experience with excellent judgement and creative problem-solving skills including negotiation and conflict resolution skills·
Fast learner with a strong teamwork-based mindset, and passion for financial markets, corporate finance and investment risk management·
Collaborative mindset, people management skills and leadership experience required·
Expert knowledge in using Bloomberg, and FactSet, similar investments systems, as well as experience to be able to apply expertise to any new investment risk management and accounting related, and order entry systems
The final salary offer will vary based on individual education, skills, and experience. The position is eligible to participate in FM's comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more.
FM is an Equal Opportunity Employer and is committed to attracting, developing and retaining a diverse workforce.
$137k-197k yearly est. Auto-Apply 2d ago
Director, Field Operations
Cogent Biosciences 4.1
Associate director job in Waltham, MA
Who We AreCogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Top-line results from registration-directed trials in NonAdvanced SM, Advanced SM and GIST are expected in 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Our Team****************************
This critical role will lead the strategic and tactical execution of field (commercial customer-facing) operations supporting the launch of bezuclastinib across 3 important indications, Cogent Biosciences' key pipeline asset. The Director of Field Operations will be a key member of the Commercial Operations and Analytics leadership team responsible for driving operational excellence for the commercial organization. We are seeking a strategic and hands-on leader to optimize field deployment, execution, and operational readiness for our upcoming launches. As a key strategic partner to senior sales leadership, this will own the design, implementation, and continuous improvement of our customer-facing operating model. The ideal candidate possesses both the strategic perspective required for sales excellence, and the executional perspective required for a field team to deliver a best-in-class launch. The ideal candidate will bring deep expertise in CRM systems, analytics, field operations, and cross-functional collaboration to drive operational excellence and accelerate launch impact. Key Responsibilities
Strategic Leadership & Business Partnering
Strategic partner to Senior Sales Leadership, Market Access, Marketing, Patient Services and Analytics to understand key functional needs that translate to field operational solutions and execution.
Engage and Align with critical cross-functional team members that support field teams (IT, HR, Compliance, Sales Training, Congress Execution, Medical, etc).
Key field operations leader for real-time issue resolution, solution development, performance monitoring and operational support needs.
Field Planning and Execution Operational Leadership
Aligned with the vision of the senior commercial leadership, develop and lead all the field planning processes (at the National and Regional level) required to enable a field force to launch in the rare disease and oncology space. This includes business and call planning, targeting and segmentation, resource allocation, budgeting, reporting and all key sales enablement tools.
Develop and lead the annual cadence of key field engagements and meetings (business reviews, key sales meetings, performance updates, etc).
Develop key field performance management and monitoring systems, processes and reporting (goals, key performance and execution metrics, etc) that are strategically aligned and visible to all stakeholders.
Ensure compliance with regulatory and legal requirements, including credentialing and spend reporting.
Enabling Customer Facing Teams with Technology, Tools and Systems
Working with senior commercial leadership to identify key technology capabilities and requirements to support an engaged and productive customer-facing organization across functions.
Collaborate with key functions (IT, L&D, Marketing) to develop, integrate and implement key field-facing tools such as CRM, call/business planning tools, peripherals (such as tablets), virtual selling capabilities, etc.
Lead the onboarding and ongoing training requirements for the field to adopt new technology and processes into their way of working.
Develop/implement novel enabling SOPs for the field force to allow them to perform more effectively.
Find opportunities to leverage technology or new digital solutions to improve productivity, simplicity and engagement of the field team.
Oversee vendor relationships related to CRM, data analytics, and field operations platforms.
Performance Management, Monitoring and Reporting
Leading an aligned approach to critical measurable indicators and outcomes related to field performance and execution.
Develop scalable reporting capabilities, field-facing dashboards, KPIs, and scorecards that enable actionable insights, performance monitoring and support coaching conversations.
Work with commercial leadership to establish the overarching philosophy of the SIP (sales incentive plan) and build the SIP integration plan for the field (quota setting process, key data sources and inputs, sales vs quota reporting capabilities, payout frequency and processes, QA/QC processes).
Build field response process and capability to respond to data, IC, and comp enquiries.
Launch Readiness and Deployment/Territory Optimization
Work with senior leadership and external partners to design a fit for purpose customer facing organization with the right capabilities to ensure a best-in-class launch.
Optimize the deployment of field resources and geographies aligned with the market opportunities across Cogent's three potential indications, HCP targeting, key centers of excellence in each territory.
Support the scale and build of the field operations resourcing and infrastructure to prepare for launch.
Act as a key member of the Launch Readiness workstream to represent the field readiness and key milestones reflecting the preparations for field activation on Day 1.
Qualifications
Bachelor's degree in Business, Life Sciences, or related field; MBA or advanced degree preferred.
8+ years of experience in pharmaceutical or biotech field operations, with launch experience in rare or specialty diseases.
Proven expertise in CRM systems (e.g., Veeva, Salesforce), field analytics, and commercial data infrastructure.
Strong understanding of field force effectiveness, territory design, and incentive compensation.
Experience in a startup or growth-stage biotech environment preferred.
Excellent project management, communication, and cross-functional collaboration skills.
Ability to thrive in a dynamic, fast-paced, and highly regulated environment.
Our Locations
Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.
Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent's discovery research organization.
Our Offer To You
To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
$83k-144k yearly est. Auto-Apply 60d+ ago
Director, Field Force Operations
Scholar Rock 4.5
Associate director job in Cambridge, MA
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at
ScholarRock.com
and follow
@ScholarRock
and on
LinkedIn
.
Summary of Position:
In this role, you will be responsible for a wide variety of projects across the Commercial organization to include, but not limited to, functioning as the business lead for sales sizing and alignment, field incentive compensation design and implementation, field analytics and reporting, implementation of commercial systems, collaboration with brand marketing/e-marketing initiatives and supporting KPIs for overall performance. Additionally, you will identify critical business issues and opportunities for growth, collaborate with cross-functional teams, and work to embed an external market point-of-view into the strategic direction of the company.Position Responsibilities:
Strategic Leadership & Operational Excellence
Define and implement a structured framework of goals and tactics to build a best-in-class Field and Sales Operations organization.
Establish and maintain robust analytics and operational processes that effectively support the General Managers and Sales organization.
Data Governance & Systems Integration
Serve on a cross-functional data governance team to define business rules and processes that ensure data integrity and consistency.
Partner with Sales and IT to design, deploy and maintain Veeva both in the US and ROW
Provide Field Operation Support for ROW
Ensure organizational compliance with CRM data standards and quality protocols.
Sales Enablement & Field Optimization
Train the commercial field sales team on systems, tools, and processes to maximize efficiency and adoption.
Develop and refine field sizing and deployment strategies to optimize sales force effectiveness and meet business objectives.
Manage territory alignment and roster systems to ensure optimal resource utilization.
Manages the field sales force credentialling program
Performance Management & Incentives
Lead the development and execution of incentive compensation programs aligned with strategic goals, including plan design, governance, goal setting, reporting, and payout processing.
Monitor departmental performance against KPIs and collaborate with commercial leadership to drive continuous improvement.
Cross-Functional Collaboration & Commercial Readiness
Oversee and execute a broad range of commercial initiatives to ensure organizational readiness for product launches.
Collaborate across the Commercial team to align operational strategies with key business objectives and priorities.
Candidate Requirements:
Bachelor's degree in business, science or related field. A master's degree (MBA) strongly preferred.
8-10 years of experience working in the pharmaceutical or biotech industry with five plus years supporting field sales teams.
Extensive experience supporting technical design of commercial systems. Implementation experience a must.
Extensive experience with Veeva CRM, data management and incentive compensation
Experience with Symphony, IQVIA. CROSSIX and related pharmaceutical sales data
Experience working with field sales teams, field reporting and incentive compensation
Strong analytical skills with the capability to appropriately define issues, questions and data; to comprehend quantitative methods and analytical techniques; to perform accurate analysis (correctly calculated numbers, accurate graphs); to cross-check data and assumptions; to document and establish data trails; and to think creatively about different ways to analyze data and information
Excellent quantitative background that supports the analysis of data to better understand market dynamics and provide insights into product performance and marketing strategy.
Strong interpersonal skills with demonstrated ability to drive toward consensus.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees
.
$83k-144k yearly est. Auto-Apply 53d ago
Associate Director Pricing and Contracts
EPM Scientific 3.9
Associate director job in Boston, MA
AssociateDirector, Contracts and Pricing
Department: Market Access
About Our Client Our client is a global leader in healthcare innovation, focused on improving patient access and delivering value through science and technology. They operate across prescription medicine, consumer health, and specialty care, driving growth through strategic partnerships and cutting-edge solutions.
Job Summary
The AssociateDirector, Contracts and Pricing - Prescription Business Unit (U.S.) will lead initiatives to develop, model, execute, and measure access and reimbursement strategies. This role ensures successful product launches, maximizes market adoption, and supports lifecycle management from early development through loss of exclusivity.
Key Responsibilities
Achieve financial targets: manage forecasts, invoices, accruals, and validation through budgeting and financial review processes.
Oversee market access and reimbursement operations, including managed care contracting, payer negotiations, and rebate budgets.
Lead Gross-to-Net modeling for portfolio and new launches; develop robust forecasts using contract data and insights.
Collaborate with leadership and cross-functional teams to align on market access strategies and GTN assumptions.
Serve as SME for payer negotiations; assess risks and opportunities to inform contract terms and conditions.
Manage communication plans, KPI reporting, and compliance with healthcare regulations.
Support business development and new product launches with market access assessments and go-to-market strategies.
Qualifications
Strong experience in market access, pricing, and contracting within the pharmaceutical or healthcare industry.
Expertise in financial modeling, forecasting, and payer negotiations.
Ability to manage complex projects and collaborate across functions.
Excellent analytical, communication, and strategic thinking skills.
How much does an associate director earn in Hingham, MA?
The average associate director in Hingham, MA earns between $84,000 and $176,000 annually. This compares to the national average associate director range of $79,000 to $164,000.