Allucent

• Responsible for overall quality and management of the delivery clinical trial projects and programs • Manages complex, cross-functional resource requirements in line with budgeted, time, scope, and quality expectations for project delivery • Oversees budgets and ensuring correct financial forecasting, planning, invoicing and timely implementation of out of scope activities • Reviews and approves content and costing of proposals • Ensures effective risk management across the project delivery lifecycle • Negotiates and influences internal and external team members in a professional manner and with successful outcomes • Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills • Balances multiple competing priorities, with effective and efficient resource utilization across projects and programs • Serves as key contact for assigned clients on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs • Shows knowledge of and insight into general business principles and practices, and is able to balance business priorities • Demonstrates a growth mindset, and approaches complex challenges with creativity and flexibility • Leads by example and encourages team members to develop strong solutions for clinical trial delivery • Supports the recruitment and interviewing of new employees • Responsible for supervision of project staff and communication with functional managers, including performance feedback • 10% of Business travel is required for this position, including possible international travel

• Driving project success by leading cross-functional teams to deliver clinical trials on time, within scope, and on budget. • Ensuring excellence and compliance by developing and executing project plans aligned with GCP, SOPs, and regulatory standards. • Aligning stakeholders by serving as the primary point of contact for sponsors, vendors, and internal teams. • Optimizing vendor performance through strategic selection, management, and oversight. • Mitigating risks and control budgets by proactively addressing challenges, scope changes, and resource allocation. • Maintaining inspection-ready documentation by leading key meetings and ensuring the Trial Master File and study records are complete.

Senior Medical Director, Executive Medical Director Location: USA, Remote Job Description: We are seeking a Sr Medical Director/Executive Medical Director to provide medical leadership across Phase I–IV clinical development programs, serving as a trusted advisor to clients while driving clinical strategy, patient safety, and operational excellence. This is an opportunity to influence high-impact global studies within a dynamic, growth-focused organization dedicated to advancing drug development. This role is based in United States(remote), either Part-Time or Full-Time. About the role As Executive Medical Director, you will play a critical role in shaping clinical development strategy and providing medical leadership across complex global studies. Your main responsibilities will include but not limited to: - Advise sponsors on product development strategy, protocol design, endpoint selection, and clinical trial feasibility for Phase I–IV programs - Provide medical oversight and safety leadership for assigned clinical trials, including medical monitoring and safety review activities - Support business development efforts through proposal review, budget input, and participation in sponsor and bid pursuit meetings - Lead and support critical safety activities including SAE/SUSAR review, DSMBs, dose escalation meetings, and protocol deviation oversight - Review and ensure scientific integrity and medical consistency across key trial documents including protocols, ICFs, CSRs, DSURs, and PSURs - Mentor cross-functional teams and provide therapeutic expertise to internal stakeholders, investigators, and clients throughout study execution Requirements About You If you are an experienced physician leader with deep expertise in global clinical development, medical monitoring, and clinical trial strategy within a CRO, biotech, or pharmaceutical environment and you bring strong scientific credibility, executive presence, and the ability to build trusted relationships with sponsors while leading complex clinical programs with confidence and collaboration, then this role is for you. To be successful we are looking for the following traits and behaviors: - MD or PhD required - Minimum 5-10 years of relevant work experience supporting USG funded trials with Department of Defense or Department of Health and Human Services - 5+ years of clinical development experience supporting or overseeing infectious disease medical countermeasure development programs - Infectious Disease expertise required with research specialty in immunology, microbiology, virology, or epidemiology - Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies Benefits About Allucent Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments. If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow. Together we SHINE. Find more information about our values. Benefits of working at Allucent include: - Comprehensive benefits package per location - Competitive salaries per location - Departmental Study/Training Budget for furthering professional development - Flexible Working hours (within reason) - Opportunity for remote/hybrid* working depending on location - Leadership and mentoring opportunities - Participation in our enriching Buddy Program as a new or existing employee - Internal growth opportunities and career progression - Financially rewarding internal employee referral program - Access to online soft-skills and technical training via internal platforms - Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects - Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within a reasonable distance from one of our . “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.” #LI-Remote

• Advise sponsors on product development strategy, protocol design, endpoint selection, and clinical trial feasibility for Phase I–IV programs • Provide medical oversight and safety leadership for assigned clinical trials, including medical monitoring and safety review activities • Support business development efforts through proposal review, budget input, and participation in sponsor and bid pursuit meetings • Lead and support critical safety activities including SAE/SUSAR review, DSMBs, dose escalation meetings, and protocol deviation oversight • Review and ensure scientific integrity and medical consistency across key trial documents including protocols, ICFs, CSRs, DSURs, and PSURs • Mentor cross-functional teams and provide therapeutic expertise to internal stakeholders, investigators, and clients throughout study execution

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Project Director (PD) to join our A-team (office-based*/remote). As a PD at Allucent, you are responsible for coordinates and oversees operational project teams, customer satisfaction and continuous improvement of processes within the Global Clinical Operations (GCO) department. This position controls and monitors the quality and full-service delivery of clinical trial Allucent customers. About this role: As a proactive project director, you will: - **Oversee the project **and be responsible for the overall quality and management of the deliver clinical trial projects and programs. This includes overseeing the budget, reviewing and approving content and costing of proposals, problem solving with project teams, and balancing multiple competing priotities. - **Serve as the key contact for assigned clients** on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs. - **Lead the project team. **You will demonstrate knowledge of and insight into general business principles and practices, demonstrate a growth mindset, and support the recruitment and interviewing of new employees.

Title: Director, Clinical Pharmacology Location: Cary, North Carolina, United States Remote Job Description: At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Director, Clinical Pharmacology to join our A-team (office-based*/remote). As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading Clinical Pharmacology activities within the Clinical Pharmacology, Modeling, and Simulation unit of Allucent. About the role: As an expert in clinical pharmacology, you will: - Take independent leadership in providing strategic clinical pharmacology advice to clients within a cross-functional team, covering overall drug development activities. - Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies (including renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and offer recommendations to enhance pharmacokinetic sampling and dosing strategies. - Thoroughly assess the technical and scientific components of PK and PK/PD projects and programs for clients, with knowledge of noncompartmental analysis as well as population PK, PBPK, and QSP modeling. - Oversee the development of statistical and PK analysis plans, standalone PK/PD reports, and PK/PD sections of clinical study reports, and take the lead in reviewing clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packages, and other clinical and regulatory documents. Requirements To be successful you will possess: - PharmD or Ph.D. in a relevant area - 8+ years of relevant work experience - Strong written and verbal communication skills including good command of English language - Client focused - Ability to work in a fast-paced environment Benefits Benefits of working at Allucent include: - Comprehensive benefits package per location - Competitive salaries per location - Departmental Study/Training Budget for furthering professional development - Flexible Working hours (within reason) - Opportunity for remote/hybrid* working depending on location - Leadership and mentoring opportunities - Participation in our Buddy Program as a new or existing employee - Internal growth opportunities and career progression - Financially rewarding internal employee referral program Disclaimers: *Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our . “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.” #LI-Remote #LI-Hybrid #LI-TCW

- Deliver and exceed annual sales targets by developing and managing a robust pipeline of opportunities. - Sell Allucent’s full portfolio of development solutions — with a focus from Phase I to Phase III—including clinical pharmacology, regulatory strategy, biostatistics, project management, monitoring, data management, and beyond. - Coordinate and drive business opportunities along the sales cycle from lead generation, CDA, RFI/RFP, bid defense, award, through contract execution. - Coordinate, drive and host client meetings and bid pursuits, providing leadership, guidance and insights of client needs, wishes and expectations to our relevant internal teams in order to ensure winning proposal/bid strategies including support preparation of proposals. - Build strong, trust-based relationships with senior decision-makers and influencers. - Represent Allucent at key industry events, conferences, and client meetings to showcase our capabilities and expand market presence.

**Your main responsibilities will include, but are not limited to:** • Lead and perform population pharmacokinetic analyses using advanced modeling tools and methodologies • Develop and implement innovative approaches to improve the efficiency and accuracy of pharmacokinetic analyses • Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize PK sampling and dosing strategies • Provide strategic advice to clients, assume responsibility for deliverables, and develop clinical pharmacology plans • Write and review pharmacokinetic reports and the clinical pharmacology sections of regulatory documents • Represent clients in interactions with regulatory authorities and contribute to business development and relationship management

__About the role__ This role combines scientific leadership and strategic impact, leading population PK analyses while developing innovative approaches to improve efficiency and accuracy. You will design, analyze, and interpret clinical pharmacology studies, provide strategic guidance to clients, and contribute to regulatory documents and agency interactions. In addition, you’ll foster client relationships, support business development, and stay at the forefront of PK/PD advancements to drive continuous improvement. **Your main responsibilities will include but not limited to: ** - Lead and conduct population PK analyses using advanced modeling tools and methodologies - Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis - Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies  - Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans - Author and review PK reports and clinical pharmacology sections of regulatory documents - Represent clients in regulatory interactions and contribute to business development and relationship management

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits. • Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements. • Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection. • Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety. • Activities around regulatory affairs, site activation and study-startup.