GENERAL SUMMARY

The Director, FP&A – TechOps serves as the primary finance business partner to the TechOps organization, providing end‑to‑end financial leadership across Manufacturing, Supply Chain, CMC Quality, and External Manufacturing as 4DMT transitions from late‑stage clinical development to commercial readiness and launch. This role is responsible for driving financial planning, forecasting, and decision support for a rapidly scaling TechOps organization. The Director will partner closely with TechOps leadership to translate operational plans into clear financial outcomes, proactively manage risks, and enable disciplined, data‑driven decisions.

The position is expected to operate as a hands‑on, strategic individual contributor, with future people management potential as the organization scales.

The Director role will report to the CFO and is expected on site 

MAJOR DUTIES & RESPONSIBILITIES:

• Act as the primary finance partner to TechOps leadership, supporting strategic planning, operational decisions, and investment prioritization
• Translate TechOps strategy, timelines, and operating plans into financial forecasts with implications, trade‑offs, and scenarios
• Own the TechOps annual budget, rolling forecast, and long‑range plan inputs through close coordination with business partners
• Develop and maintain detailed spend, headcount, and models aligned to clinical needs, manufacturing runs and launch timelines
• Ensure financial plans accurately reflect changes in demand, supply constraints, tech transfers, and scale‑up activities
• Lead scenario and sensitivity analyses to assess financial impact of operational risks and strategic alternatives.
• Deliver clear monthly variance analysis, forecasting updates, and KPI reporting for TechOps leadership and Finance.

• Support company‑wide cash flow forecasting and runway modeling, with particular focus on timelines and spend phasing

QUALIFICATIONS: 

Education: 

• Bachelor's degree in Accounting, Finance, or related field; CPA or MBA preferred

Experience: 

• 10+ years of progressive experience in FP&A roles
• Prior biotech, pharmaceutical, or life sciences experience required
• Experience supporting a late‑stage clinical development organization through commercial launch (ideally first global product launch) required
• Experience with ERP selection and implementation
• Direct experience partnering with TechOps, Manufacturing, Supply Chain, and/or CMC organizations required
• Understanding of CMC processes (e.g. upstream, downstream, fill finish, pack and label, etc)
• Experience partnering with Clinical Development is a plus

Skills: 

• Proficiency in finance software (e.g., NetSuite, Adaptive) and Microsoft Excel
• Strong analytical and problem-solving skills, with the ability to interpret complex financial data and trends
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional teams
• Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment

Travel: <5%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $237,000 - 263,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 

GENERAL SUMMARY: 

The Associate Director, Clinical Supply is responsible for projecting, planning, executing, and overseeing all supply chain activities related to clinical trial materials. This includes managing the procurement, production, packaging, labeling, distribution, and inventory of clinical trial materials to meet company goals within the defined timelines. This role ensures that clinical supplies, including investigational product, comparators, auxiliary IMPs, and supplies, are delivered on time, within budget, and in compliance with regulatory requirements. This role involves close collaboration with various departments, including Clinical Operations, Clinical Science, Quality Assurance, Regulatory Affairs, Manufacturing, and external vendors. Effective communication with stakeholders at all levels is required to provide regular updates on supply chain status and address any concerns.

Serve as the primary point of contact for clinical supply-related inquiries and issues.

RESPONSIBILITIES: 

Supply Planning and Management:

• Develop and implement clinical supply strategies to support global clinical trials
• Lead Phase 1 to 3 clinical trial materials planning and execution. Participate in cross-functional discussions early in the study design phase to ensure that material lead-time is properly built in for overall program timeline.
  • This includes Investigational Products (IP), diluent, comparator drugs, ancillary supplies, or any other clinical materials required and identified by each project team
• Create detailed supply plans based on trial requirements, enrollment forecasts, and study timelines
• Oversee material requirements for domestic and international study execution. Ensure procurement, production, packaging, labeling, and distribution of clinical trial materials are done per applicable local and international guidance

Inventory Control and Distribution:

• Manage inventory levels to ensure sufficient supply of clinical trial materials while minimizing waste.
• Review of clinical supply requests, placing ancillary supply orders, and communicating IP demands
• Coordinate the distribution of clinical supplies to CMO and study sites, ensuring timely delivery and adherence to protocols.
• Monitor and track shipment status, resolving any issues that arise during transit.

Vendor Management.

• Identify, select, and manage relationships with suppliers, manufacturers, and logistics providers including CMOs and CROs.
• Plan and coordinate clinical supply activities including labeling, packaging, distribution of clinical trial supplies, randomization, and drug accountability systems control.
• Negotiate contracts and service agreements with vendors to ensure cost-effective and high-quality supply chain operations.

Project Management:

• Participate in supply chain business process development project.
• Drive continuous operational performance improvement efforts.
• Ensure compliance with Good Manufacturing Practices and applicable state and federal regulatory authorities.

Others

• Generate and maintain various clinical supply inventory reports.
• Ensure process execution is conducted per internal policy and procedures
• Identify opportunities for process improvements and implement best practices in clinical supply chain management.
• Perform other duties as assigned.

 QUALIFICATIONS: 

Education: 

• Bachelor’s degree in supply chain or other disciplines with equivalent industry experience

Experience: 

• 8+ years of experience in clinical or in combination with commercial supply chain management, with at least 3 years in a senior or managerial role.
• In-depth knowledge of clinical trial processes, GMP, GCP, and regulatory requirements
• Proven experience in managing complex global supply chains for clinical trials (including Europe, APAC and South America)
• Proven experience with high-complexity Phase 3 trials

Skills: 

• Strong project management skills, with the ability to lead cross-functional teams and manage multiple priorities.
• Excellent negotiation, communication, and interpersonal skills.
• Proficiency in supply chain management software and tools.
• Strong analytical and problem-solving abilities.
• Ability to work in a fast-paced, dynamic environment and adapt to changing priorities.

Travel: <5%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $177,000 - 205,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 

GENERAL SUMMARY:

The Clinical Technology, IT professional is the accountable owner for the strategy, delivery, and operational integrity of information systems supporting 4DMT’s Clinical Research and Development organization. This role ensures clinical systems are fit for purpose, inspection-ready, and maintained in a validated state, while advancing technology solutions that enable efficient, compliant clinical execution.

The position serves as the primary liaison between Clinical R&D, Data Management, IT, and external vendors, driving alignment, governance, and disciplined system ownership across the full lifecycle—from design and implementation through operation and retirement.

MAJOR DUTIES & RESPONSIBILITIES:

• Own and operate clinical systems as system owner, including access control, configuration, validation, and lifecycle management.
• Ensure systems remain compliant with GxP regulations and internal SOPs, preserving data integrity and inspection readiness.
• Lead requirements definition, solution design, and implementation planning with cross-functional stakeholders.
• Provide Level-2 application support and vendor coordination for incident resolution and system enhancements.
• Maintain and continuously improve system documentation, including validation deliverables, SOPs, and operational records.
• Partner with Clinical Data Management to support data quality, flow, and operational needs.
• Execute core system governance activities, including performance monitoring, upgrades, disaster recovery testing, access reviews, and license and vendor management.
• Drive system adoption through training, documentation, and user enablement.
• Support audits and regulatory inspections, including inspection responses, remediation, and CAPA closure.
• Contribute to product roadmaps and release planning, balancing business value, regulatory risk, and technical feasibility.
• Manage and maintain collaborative relationships with core business partners.

QUALIFICATIONS:

• 8–12+ years of experience implementing and operating technology solutions supporting clinical research and development.
• Proven experience across the CSV lifecycle, including validation, production deployment, support, and decommissioning.
• Strong working knowledge of FDA and EMA regulations, including 21 CFR Part 11, Parts 210/211, EU Annex 11, CSA principles, and GDPR.
• Broad technical fluency across applications, infrastructure, cloud platforms, integrations, and operations.
• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related discipline (or equivalent experience).

Preferred Experience:

• Collaboration with Clinical Data Management and Biometrics teams.
• Experience with Medidata Rave, SAS (Grid, Viya, 9.4), Spotfire, and Veeva TMF and RIM.
• Experience operating systems in Google Cloud environments.
• Strong vendor management and service governance experience.
• Experience with product road mapping, KPIs, and SLAs aligned to clinical priorities.
• Exposure to low-code platforms and applied AI in clinical research.

Base salary compensation range: $110,000 - $150,000