Description of Role

Centessa Pharmaceuticals is seeking an Executive Director/Head of Toxicology to provide scientific and strategic leadership for nonclinical safety across discovery and development programs, with an emphasis on small‑molecule therapeutics. This role leads toxicology and safety pharmacology strategy to support target selection, lead optimization, IND‑enabling activities, and clinical advancement. Reporting to our SVP, Nonclinical & Translational Development, the Head of Toxicology partners closely with cross‑functional teams and represents nonclinical safety in regulatory interactions while building a strong, high‑performing toxicology organization. 

Key Responsibilities

• Lead and mentor a team of toxicologists and technical/operational staff, fostering scientific excellence and professional growth
• Define and execute nonclinical safety strategies across discovery, preclinical, and clinical stages
• Provide expert toxicology and safety pharmacology input to cross‑functional development teams
• Lead nonclinical sub‑teams as an integrated development head, providing cross‑functional oversight across Toxicology, DMPK, Bioanalytical Sciences, and Clinical Pharmacology to ensure aligned, program‑ready nonclinical strategies
• Serve as the primary nonclinical representative on Program Development Teams (PDTs) and at internal governance and external forums, effectively championing program strategy, presenting to regulatory authorities, and holding scientific ground with senior leadership, partners, CROs, and health authorities
• Design, oversee, and interpret GLP, non‑GLP, investigative, and in vitro toxicology studies
• Develop safety strategies for new targets, lead optimization programs, and platform technologies
• Oversee toxicology and safety pharmacology studies conducted internally and at CROs
• Ensure high scientific quality, compliance, and timely delivery of nonclinical study outputs
• Author and critically review toxicology sections of regulatory documents (e.g., pre‑IND, IND, IBs)
• Partner with biology, DMPK, pathology, pharmacology, clinical, and regulatory colleagues to drive integrated decision‑making
• Present nonclinical safety data and risk assessments to project teams and senior R&D leadership
• Serve as the primary nonclinical safety representative in regulatory agency interactions
• Support product defense and regulatory submissions through robust scientific rationale
• Provide strategic guidance on safety issue resolution and investigational toxicology approaches
• Contribute to portfolio‑level planning and prioritization of nonclinical safety resources
• Build scalable toxicology capabilities to support a growing and diverse pipeline

Qualifications

• PhD in Toxicology, Pharmacology, Pathology, DVM, or related discipline; board certification (e.g., DABT, ERT) - required
• 18+ years of experience in pharmaceutical or biotechnology R&D with a strong track record in nonclinical and regulatory toxicology
• Proven ability to function as an upward‑facing nonclinical leader and generalist, with the credibility and judgment to represent project development team agenda at decisional governance meetings, engage confidently with regulatory agencies, and serve as a trusted development partner to senior leadership
• Deep expertise supporting small‑molecule programs across discovery, IND‑enabling, and early clinical development
• Strong working knowledge of national and international GLP guidelines
• Demonstrated experience defining and executing nonclinical safety strategies to support diverse pipelines and novel biology
• Proven leadership experience building, managing, and mentoring toxicology teams within a collaborative, matrixed environment
• Extensive experience preparing and reviewing nonclinical sections of global regulatory submissions and engaging with health authorities (FDA, EMA)
• Strong ability to integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform development decisions
• Experience overseeing outsourced toxicology and safety pharmacology studies and managing CRO partnerships
• Excellent communication and influencing skills, with the ability to partner effectively across Early Development, Research, and Regulatory functions in a fast‑paced environment

Compensation 

The annual base salary range for this position is $320,000.00 to $350,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location

The Executive Director, Head of Toxicology role is a remote role based in the US, with occasional travel. 

POSITION: Full-Time, Exempt

Description of Role

The Executive Director, Regulatory CMC will provide strategic leadership for global CMC regulatory activities across all stages of drug development and life cycle management. Reporting to the SVP, Regulatory and Medical Writing, this role serves as a liaison to health authorities, driving regulatory strategies, overseeing high-quality submissions, and ensuring compliance with FDA, EMA, and ICH guidelines. The position requires deep expertise in small molecule development, strong cross-functional collaboration, and the ability to influence organizational policies and processes in a fast-paced, growing environment. The ideal candidate combines strategic vision with hands-on leadership to deliver innovative, compliant solutions that accelerate development and commercialization.

Key Responsibilities

• Provide overall regulatory CMC strategy for drug development programs and life cycle management, ensuring alignment with corporate objectives and timelines.
• Serve as a spokesperson and trusted liaison with FDA and other health authorities, leading negotiations and presenting CMC positions effectively.
• Develop de-risking strategies for CMC development, assess change controls, and identify opportunities to accelerate development in a dynamic environment.
• Lead creation and execution of comprehensive CMC development plans for new products, ensuring integration with Technical Operations and external partners.
• Partner with supply chain, clinical operations, and manufacturing teams to ensure readiness and compliance for clinical and commercial supply.
• Oversee preparation and quality of all CMC regulatory submissions (INDs, BLAs, MAAs, DMFs, IMPDs, amendments, annual reports), providing strategic direction and ensuring global compliance.
• Drive the development and implementation of departmental policies, SOPs, and best practices to support scalability and operational excellence in a growing organization.
• Interpret and communicate regulatory CMC requirements and expectations to internal teams and external partners to ensure program objectives are met.
• Contribute to corporate initiatives aimed at improving regulatory standards, systems, and processes across the organization.

Qualifications

• Master’s degree in chemistry, pharmaceutical sciences, or a related scientific field (PharmD or PhD preferred).
• Minimum 15 years in the pharmaceutical industry, including at least 7 years in Regulatory CMC.
• Demonstrated experience across early-stage, late-stage development, and life cycle management for small molecule products.
• Comprehensive understanding of FDA, EMA, and ICH CMC guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
• Proven experience preparing and submitting CMC regulatory documents (e.g., INDs, IMPDs, CTAs, NDA's, MAAs) and leading successful interactions with health authorities such as FDA and EMA.
• Track record of developing and executing CMC regulatory strategies, balancing near-term objectives with long-term goals.
• Strong leadership skills with the ability to work effectively in a matrixed environment; excellent verbal and written communication skills to articulate regulatory viewpoints to diverse audiences.
• Ability to thrive in a fast-paced, collaborative environment and comfortable with both strategic planning and hands-on execution.

Compensation

The annual base salary range for this job level is $285,000 - $350,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Executive Director, Regulatory CMC role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

Description of Role

Centessa’s CMC group is seeking a Senior Director of Analytical Development within the CMC group. The successful candidate will have hands-on experience in the development and validation of raw material, in-process, small molecule drug substance, and solid oral dose drug product methods at all stages of development. T 

Reporting to the VP, CMC, the Senior Director will drive analytical method gap assessments, method development, and strategy at various CDMOs and liaise cross-functionally with drug substance and drug product teams across programs.  Comprehensive working knowledge of cGMP and Regulatory guidance as they relate to regulatory starting material, drug substance and drug product development, characterization, release, and stability testing of small molecules is paramount.   

This position will be accountable for all analytical CMC data from external CDMOs to meet company deliverables and timelines.  Travel to vendors both domestically and internationally will be required. 

Key Responsibilities

• Lead analytical strategy related to phase-appropriate method development, validation, and product characterization for multiple programs
• Collaboratively work in a team environment to lead drug substance and drug product analytical development activities primarily at third-party vendors including method implementation, qualification/validation, and transfer in support of pre-IND through Registrational programs
• Review method validation protocol and reports, and test data for release, stability, and characterization
• Save and store documentation, generate stability result tables, file stability data for expiry and shelf-life assignments
• Lead specification settings based upon batch history and supporting analytical data
• Act as the CMC team analytical representative member in program development teams  
• Act as role model and subject matter expert for junior analytical scientists
• Significantly contribute to CMC analytical aspects of regulatory filings including regulatory starting material justifications, justification of specifications, discriminatory and quality control dissolution method development, and structural elucidations
• Review and drafting of internal technical reports and information for analytical sections in global submission documents and modules (e.g. IND, IMPD, NDA, MAA, etc) as well as responses to Regulatory requests for information
• Work cross-functionally with Quality as a technical expert to aid in analytical OOE/OOT/OOS investigations, deviations, and other troubleshooting
• Active participation in batch record review 

Qualifications

• Advanced degree in chemistry, pharmaceutical sciences, or related field (minimum BS/MS required; PhD strongly preferred) with 15+ years of small molecule pharmaceutical industry experience
• Extensive experience in late phase analytical development of small molecule oral solid dosage forms
• Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
• Strong technical background in chemical and physical characterization, including polymorphism, particle size, residual solvents, process impurities (e.g., genotoxic, nitrosamines), and forced degradation mechanisms
• Significant experience in analytical method development and GMP qualification/validation, including assay, related substances, and dissolution
• Proven ability to manage and direct outsourced analytical activities, including assay development, stability, and quality control at CDMOs
• Hands-on experience designing, managing, and interpreting stability programs (real-time, accelerated, and forced degradation)
• Strong understanding of product quality attributes and control strategies for small molecule synthetic processes
• Demonstrated leadership in coordinating analytical and broader CMC activities supporting development and commercialization
• Excellent project management, organizational, and prioritization skills in fast-paced, multi-project environments
• Strong analytical planning, resource management, and budget oversight skills across global CDMO networks
• Effective decision-maker and communicator, able to work independently while collaborating across functions and organizational levels 

Compensation 

The annual base salary range for this position is $240,000.00 to $290,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location

The Senior Director, Analytical Development, CMC (Small Molecule) role is based in the US, with travel. 

POSITION: Full-Time, Exempt

Description of Role

Key Responsibilities

Strategic Leadership & Oversight 

• Develop and execute a comprehensive pharmacovigilance (PV) strategy aligned with corporate objectives and regulatory expectations.
• Lead safety governance and benefit-risk management for small molecule assets across development and post-marketing.
• Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA, etc.).
• Provide strategic safety input into clinical trial designs, protocols, and regulatory submissions.
• Establish and oversee PV partnerships, vendors, and external collaborations. 

Operational & Regulatory Compliance 

• Lead the safety surveillance and signal detection process, ensuring timely identification and mitigation of safety risks.
• Oversee the preparation and submission of safety reports (e.g., DSURs, PSURs, RMPs, SUSARs, IND safety reports, 15-day alerts).
• Ensure robust case processing, signal evaluation, and risk management processes are in place.
• Represent the company in regulatory interactions regarding safety matters (FDA, EMA, etc.). 

Cross-Functional Collaboration 

• Work closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to integrate safety considerations into decision-making. 
• Partner with Regulatory Affairs to support new drug applications (NDAs) and marketing authorizations.
• Support DSMBs, advisory boards, and investigator meetings with safety expertise. 

Team Leadership & Development 

• Build and lead a high-performing pharmacovigilance team, fostering a culture of scientific excellence and compliance.
• Provide mentorship and guidance to internal safety professionals. 

Compensation

The annual base salary range for this position is $350,000.00 to $380,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Vice President, Pharmacovigilance and Safety role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

Description of Role

We are seeking a Senior Scientist, Drug Safety (Pharmacovigilance) to support pharmacovigilance activities across Centessa’s clinical-stage development programs. Reporting to Centessa’s Head of Safety and Pharmacovigilance, this role will contribute to the review and analysis of safety data to support ongoing safety surveillance, regulatory compliance, and program execution. The Senior Scientist will work closely with cross-functional partners and external vendors to ensure high-quality safety deliverables and maintain inspection-ready pharmacovigilance processes in a fast-paced, development-focused environment. 

Key Responsibilities

• Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs. 
• Lead the development of high-quality case narratives and guide the scientific preparation of regulatory ready case submissions, including SUSARs, in alignment with global reporting requirements. 
• Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products. 
• Oversee literature surveillance to identify new or evolving safety information, interpret clinical relevance, and communicate findings to cross-functional stakeholders. 
• Ensure the scientific integrity and quality of safety data through expert review of complex cases and mentorship of junior team members in case assessment and safety data interpretation.  
• Provide senior level scientific input into the preparation and review of DSURs, line listings, safety summaries, and safety-related sections of protocols, Investigator’s Brochures, and regulatory submissions. 
• Serve as the lead drug safety representative on cross-functional study teams, shaping safety strategy, influencing program decision-making, and advising on safety issue management.
• Maintain expert level knowledge of therapeutic areas and global drug safety regulations, guidelines, and evolving best practices (e.g., FDA, EMA, ICH, CIOMS), and apply this expertise to program decisions and safety governance. 
• Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.  
• Lead or contribute to complex, cross-functional safety projects, safety signal evaluations, and ad-hoc scientific analyses to support portfolio needs and organizational priorities. 

Qualifications

•  PharmD or PhD in scientific field
• 6+ years of experience of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.  
• Prior experience facilitating in Safety Risk Assessment Meetings / Safety Review activities required. 
• Working knowledge of global PV regulations and guidelines applicable to clinical development (e.g., FDA, EMA, ICH, GCP).
• Experience with PV databases and safety surveillance tools (e.g., Argus, ArisGlobal, Vault Safety); familiarity with MedDRA coding preferred.
• Experience supporting clinical safety case processing and aggregate reporting.
• Strong analytical skills, attention to detail, and comfort working across multiple programs.
• Clear communicator who works effectively in small, cross-functional teams.
• CNS experience preferred. 

Compensation 

The annual base salary range for this job level is $145,000 to $190,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location 

Based in the US, with <10% travel.

POSITION: Full-Time, Exempt

Description of Role

The Sr. MSL will serve as a field-based scientific expert responsible for engaging with healthcare professionals (HCPs), supporting clinical development, and ensuring alignment with Centessa’s strategic medical objectives. This role is critical in translating complex scientific data into meaningful clinical insights and fostering compliant, evidence-based dialogue with thought leaders.

Key Responsibilities

Scientific Expertise & Thought Leader Engagement

• Maintain a high level of therapeutic area expertise and scientific knowledge relevant to Centessa’s pipeline and marketed products in alignment with Medical Affairs strategic objectives
• Engage in compliant, non-promotional scientific exchange with key opinion leaders (KOLs), investigators, and other HCPs
• Serve as a trusted scientific resource to external stakeholders, providing accurate and balanced medical information
• Deliver company-approved, high-quality medical/scientific presentations to a variety of audiences including formulary committees and healthcare professionals.
• Provide medical/scientific support for critical Centessa activities including speaker training, advisory boards, and sales training as appropriate
• Ensure accurate, timely, and compliant documentation of field-based activities in accordance with MSL organization guidelines

Clinical Trials Support

• Collaborate with Clinical Operations to identify and evaluate potential clinical trial sites and investigators based on scientific expertise, patient population, and alignment with study objectives
• Provide scientific education and protocol-specific training to investigators and site staff during site initiation visits, ensuring thorough understanding of study rationale and endpoints
• Maintain ongoing engagement with trial sites and investigators to facilitate successful execution of clinical trial objectives, provide ongoing scientific support, address protocol-related inquiries, and ensure high-quality data generation

Medical Conference Attendance & Coverage

• Attend relevant scientific and medical congresses to stay current with emerging data and trends
• Provide real-time insights and post-conference reports to internal teams
• Support Centessa’s presence at congresses through development of pre-conference plans, booth coverage, symposia participation, and KOL engagement
• Senior MSLs will be responsible to leading strategic conference planning, execution, and reporting

Scientific Materials Development

• Contribute to the development of scientific slide decks, FAQs, and educational materials
• Writing and editing Medical Information response letters
• Ensure all materials are medically accurate, evidence-based, and compliant with regulatory standards
• Collaborate with Medical Affairs and Legal teams to ensure scientific content meets internal and external guidelines

Additional Responsibilities:

• Lead MSL strategic initiatives/projects aligned with Medical Affairs and MSL organization strategy
• Develop and implement scientific training plans for the MSL team
• Contribute to MSL organization strategy in collaboration with MSL leadership
• Mentorship of MSL peers

Qualifications

• Advanced degree (PhD, PharmD, MD, DP, PsyD, DNP) in life sciences or a related field (from An Accredited College or University).
• Minimum 4+ years' experience as an MSL for a drug development company in the pharmaceutical/biotech industry
• Demonstrated understanding of sleep medicine and/or associated neuroscientific areas required 
• Exceptional verbal and written communication skills; ability to tailor scientific messages to diverse audiences and ability to interpret and communicate complex scientific data
• Proven ability to build and maintain strong relationships with KOLs, investigators, and internal stakeholders
• Strong understanding of clinical trial design, regulatory requirements, and therapeutic area landscape
• Skilled in developing and delivering scientific presentations in various settings
• Strong understanding of industry regulations and guidelines governing medical interactions
• Ability to align field activities with broader medical and corporate strategies
• Senior MSLs have a proven ability to lead and mentor peers
• Must have a valid driver’s license with a driving record that meets company requirements
• Must reside within the New England region or the New York Metro area.
• Willing and able to travel frequently within assigned territory (Boston, New York, Philadelphia, Baltimore, Detroit, Cleveland, Cincinnati)

Compensation

The annual base salary range for the Senior MSL job level is $190,000 - $230,000.

Individual compensation within these ranges will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Sr. MSL - Northeast is a remote role based in the US, with up to 60-70% travel and occasional weekends

POSITION: Full-Time, Exempt

Description of Role

Centessa is seeking an experienced Senior Director, Clinical Pharmacology to provide scientific and strategic leadership for clinical pharmacology across a diverse pipeline spanning early development through late-stage and registrational programs. Reporting to the Executive Director, Clinical Pharmacology, this position is accountable for developing and executing clinical pharmacology strategies that address the unique challenges of neuroscience drug development, including CNS exposure, dose optimization, and translational relevance. The Senior Director partners closely with cross-functional teams and represents clinical pharmacology in regulatory interactions to enable efficient, data-driven advancement of therapies across our neuroscience portfolio.

Key Responsibilities

• Lead clinical pharmacology strategy for CNS and neuroscience programs from first‑in‑human through registrational and post‑marketing stages 
• Design, execute, and interpret clinical pharmacology studies, including FIH, multiple‑ascending dose, DDI, biopharmaceutics, and patient studies 
• Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS‑specific biomarkers  
• Lead model‑informed drug development, including population PK, PK/PD, and exposure–response analyses relevant to CNS targets and clinical safety
• Assess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers  
• Serve as the clinical pharmacology lead on program teams, clinical sub‑teams, and trial working groups 
• Author and oversee clinical pharmacology sections of regulatory documents (e.g., INDs, CTAs, IBs, NDAs)  
• Represent clinical pharmacology in interactions with FDA and other global health authorities, supporting dose justification and labeling discussions  
• Partner closely with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs  
• Oversee CROs and external vendors conducting clinical pharmacology and modeling activities  
• Ensure timely communication and clear interpretation of clinical pharmacology results to internal stakeholders 
• Contribute to portfolio strategy, program prioritization, risk mitigation, and long‑range clinical development planning for CNS assets 
• Serve as a subject‑matter expert on clinical pharmacology 
• Mentor and develop clinical pharmacology talent as the pipeline and organization grow  
• Ensure high‑quality, submission‑ready documentation aligned with global regulatory standards 

Qualifications

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline 
• 8–12+ years of experience in clinical pharmacology within biopharma, with demonstrated impact in clinical drug development 
• Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support 
• Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessment 
• Demonstrated experience applying quantitative clinical pharmacology approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection and optimization  
• Proficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent 
• Experience authoring and delivering clinical pharmacology components of regulatory submissions (e.g., INDs, CTAs, NDAs) and interacting with global health authorities  
• Strong understanding of translational PK, CNS exposure considerations, and biomarker integration in neuroscience drug development  
• Excellent communication, collaboration, and leadership skills with the ability to operate effectively in a fast‑paced, matrixed environment 

Compensation 

The annual base salary range for this position is $270,000.00 to $295,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location

The Senior Director, Clinical Pharmacology role is a remote role based in the US, with occasional travel. 

POSITION: Full-Time, Exempt

SUMMARY:

Centessa continues to expand its CMC group and currently seeks an Executive Director of CMC, to lead our small molecule development programs across all CMC functions. This individual will be responsible for driving technical strategies, managing outsourced manufacturing partnerships, and overseeing all aspects of CMC development from early-to late-stage development and clinical studies. This high-impact leadership role requires a blend of scientific expertise, operational savvy, business acumen, technical efficiency, and strategic foresight. The ideal candidate brings deep experience in small molecule drug development, excels at cross-functional collaboration, and thrives in a growth-stage biotech environment.

The Executive Director, CMC will report directly to the SVP, CMC and will have ownership across the CMC function to include strategy, direct reports, team management, cross-functional leadership, and external manufacturing on our pipeline programs. Travel to vendors both domestically and internationally will be required.

RESPONSIBILITIES:

Strategic Leadership

• Oversee the implementation of end-to-end CMC strategy across Centessa’s development programs
• Translate development goals into robust CMC plans, ensuring alignment across R&D/early stage, Clinical, Quality, and Regulatory functions
• Develop long-term development manufacturing strategies that consider Phase 1/Phase 2 forecasting, demand forecasting, investment planning, inventory control, and vendor relationships
• Proactively identify and mitigate technical, production, and supply chain risks

Operational Oversight

• Act as the CMC team representative member in cross-functional developmental teams
• Oversee outsourced manufacturing activities, including CDMO contract negotiations and performance management
• Ensure timely delivery of clinical supply and maintain timelines for Registration/Primary Stability, PPQ/Commercial, and Phase 1/Phase 2 drug substance and drug product batches.
• Manage the development of budgets and timelines for CMC operations and report regularly to leadership
• Drive cross-functional meetings and milestone planning to support timely execution across drug substance and drug product for development programs
• Interface closely with key stakeholders in Quality, Regulatory, Supply Chain, Clinical, Legal, Finance, Project Management, and Non-Clinical teams in the development and execution of CMC plans
• Assist in developing documents and maintain compliance consistent with GLP and GMP standards for pre-clinical, early- and late-stage clinical development (pre-IND through Phase 3+)
• Develop and oversee SOPs, protocols/reports, and phase-appropriate specifications for pharmaceutical development and manufacturing activities
• Oversee technical transfer activities of API and drug product for supply chain resilience

Manufacturing and Technical Execution

• Supervise drug substance and drug product manufacturing and coordination of labeling, packaging, and distribution
• Oversee sourcing, planning, and logistics for raw materials, APIs, excipients, and required specialized critical reagents or equipment to meet production requirements
• Manage analytical method development and validation for starting materials, in-process controls, and final release and stability
• Participate in manufacturing site visits and pre-approval inspection readiness initiatives
• Identify, select, and manage CDMOs for process optimization, non-GMP and GMP manufacture and supply of API and drug product in support of ongoing pre-clinical and clinical programs, including delivery of scalable and cost-effective manufacturing routes that meet business requirements

Regulatory Affairs

• Collaborate with Regulatory Affairs to support the preparation and submission of CMC sections (INDs, IMPDs, NDAs, etc)
• Address CMC-related and pertinent cross-functional questions from regulatory authorities and ensure submission and response timelines are met

QUALIFICATIONS:

• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, interpersonal, leadership, and decision-making skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects and competing priorities
• Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products
• Excellent organizational skills, project management skills and detail-orientated leadership approach
• Strong experience with chemical and physical characterization of small molecules
• Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions
• Understanding of product quality attributes control strategies as applied to small molecule synthetic processes

EXPERIENCE:

• Master’s degree in Organic Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline (PhD strongly preferred).
• Minimum 18 years of pharmaceutical industry experience including at least 8 years in CMC. 
• Strong track record in CMC leadership across small molecule early-phase development and late-stage filing activities, including management of US and international CDMOs
• Extensive experience working with CDMOs and managing external partnerships
• In-depth knowledge of cGMP regulations and best practices in both clinical and commercial manufacturing
• Demonstrated success in process development, scale-up, and validation
• Prior experience drafting and submitting CMC content for regulatory filings in the U.S. and international markets, and interacting with global health authorities (IND, IMPD, NDA, MAA)
• Strong communication, project management, and organizational skills
• Proven ability to lead cross-functional teams in a fast-paced, evolving environment
• Strong skills in identifying and resolving critical issues
• Strong track record in effectively working with senior management

Compensation

The annual base salary range for this job level is $300,000 - $340,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

POSITION: Full-Time, Exempt

Description of Role

Centessa is seeking a (Senior) Clinical Trial Manager (CTM) to lead the execution of mid‑ to late‑stage global clinical studies from study start‑up through close‑out and clinical study report. The (Sr) CTM is responsible for day‑to‑day trial management, coordinating internal cross‑functional teams and overseeing CROs and external vendors to ensure studies are delivered on time, within budget, and in compliance with quality and regulatory standards. This role requires hands‑on involvement in clinical trial execution, proactive identification and resolution of operational issues, and accountability for study performance metrics and deliverable quality. The (Sr) CTM also contributes to operational planning, risk assessment, and continuous process improvement in collaboration with study team leadership.

Key Responsibilities

• Plan and execute mid‑ to late‑stage CNS clinical trials from study start‑up through close‑out, ensuring operational excellence, high data quality, and compliance with protocol, GCP, and global regulatory requirements.
• Lead day‑to‑day clinical trial operations, coordinating cross‑functional partners (Clinical Development, Data Management, Biostatistics, Regulatory, Safety) to ensure efficient trial execution and alignment to program objectives.
• Oversee CROs and external vendors supporting CNS clinical trials, including co‑monitoring activities, to ensure delivery against scope of work, timelines, budget, and quality expectations.
• Drive critical study milestones, including site activation, enrollment progress, patient retention, data cleaning, and database lock, proactively addressing operational challenges common to CNS trials.
• Review and approve CRO‑ and vendor‑generated plans and study documentation, ensuring alignment with protocol, regulatory expectations, and Centessa quality standards.
• Monitor study progress and performance using operational metrics and tools, maintaining dashboards, timelines, and financial tracking, and providing clear, timely status updates to study teams and management.
• Identify, assess, and manage operational risks, proposing practical mitigation strategies and supporting informed decision‑making to minimize impact to timelines, quality, and patient safety.
• Ensure inspection and audit readiness, including oversight of Trial Master File (TMF) set‑up, ongoing maintenance, and close‑out for CNS studies.
• Contribute to operational planning and regulatory deliverables, supporting preparation of study‑level documentation for Health Authority interactions and continuous improvement of clinical operations processes.

Qualifications

• Bachelor’s degree in a scientific or health‑related discipline.
• 5-8 years clinical trial management experience within an industry sponsor environment, supporting drug development programs.
• Experience managing clinical trials in CNS therapeutic development strongly preferred.
• Proven ability to manage global clinical studies, including coordination with investigators, CROs, and functional vendors.
• Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements applicable to clinical trials.
• Solid understanding of project management principles, including planning and managing timelines, resources, budgets, and risk–benefit trade‑offs; PMP or similar training is a plus.
• Excellent communication, collaboration, and interpersonal skills, with the ability to influence without formal authority and drive cross‑functional team performance.
• Demonstrated ability to manage multiple priorities in a fast‑paced environment, meeting aggressive timelines while maintaining quality.
• Proactive problem‑solving mindset with the ability to anticipate issues, identify creative solutions, and take initiative to address risks impacting timelines or budgets.

Compensation

The annual base salary range for the Clinical Trial Manager is $120,000 - $150,000.

The annual base salary range for the Senior Clinical Trial Manager is $145,000-$190,000.

Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The (Senior) Clinical Trial Manager is a remote role based in the US, with occasional travel (10% - 15%). 

POSITION: Full-Time, Exempt

Description of Role

Centessa is growing its clinical development organization. Reporting to the SVP, Clinical Development, the Executive will provide medical leadership and oversight to Centessa’s programs and associated clinical trials. The role requires leadership and contributions both at a strategic level and hands-on project level work.  Executive Director will have prior experience in the biotech/pharma industry, in neurodegenerative/neuropsychiatric therapeutic areas and across the development cycle of an asset (early to late phase).  

RESPONSIBILITIES:

• Primary point of contact for clinical development activities with willingness to work strategically and hands on at the program and clinical trial levels.
• Accountable for the oversight, monitoring and surveillance of overall risk, safety, benefit/efficacy to patients as well as compliant trial execution and optimal integrity of data.
• Responsible for establishing relationships and communication with KOLs, investigators and relevant site medical (or other supportive roles) personnel.
• Lead the clinical development strategy and innovative approaches for the overall clinical pathway for the asset.
• Key clinical development contributor to publication strategy and planning, authoring of publications, posters, etc., and present or support presentations, posters, etc., in conferences and meetings.
• Play a key role in regulatory and health authority interactions.
• Lead clinical development contributor to regulatory activities, submissions, and clinical sections of regulatory/health authority pre-meeting packages and initial applications, routine annual reports, ad hoc safety reports (SUSARs), interim and final CSRs, etc.
• Author asset and clinical trial level plans, charters, documents.
• Determine optimal clinical trial design options that are innovative, patient centric, cost efficient, and enable meeting business goals. 
• Responsible for review, analysis and interpretation of all clinical trial data including assessment of protocol deviations.
• Lead asset level clinical sub-teams and play key leadership role on program team for clinical development.
• Lead asset level and trial level medical forums as needed (safety review committee, ad board, KOL meetings, medical review/discussions of patient cases, cohort review meetings, etc.).  
• Attend and present as needed at core team meetings, investigator meetings, site visits, etc.
• Liaise with cross functional partners, vendors, and CROs to ensure the progression of clinical studies within the expected time frame.
• Provide clinical evaluation and interpretation of pre-clinical results.
• Remain current on the development of  orexin agonists and  the relevant therapeutic areas through review of the scientific literature, interactions with KOLs and other external experts and attendance at relevant scientific meetings, to provide input and guidance for the strategic direction of Centessa clinical stage programs. 

QUALIFICATIONS:

• MD required, MD/PhD strongly preferred (includes internationally recognized equivalent)
• Minimum 10 years of overall experience (academia, clinical practice, pharma/biotech industry, etc.)
• Minimum 5 years of pharmaceutical/biotech industry experience, including managing clinical development and clinical science teams, clinical development programs and clinical trials
• Prior pharma/biotech and line management experience – Required
• CNS therapeutic area (particularly neurodegenerative/neuropsychiatric) experience- Required
• Willingness to deliver project and tactical level work
• Excellent working knowledge of regulations across various agencies (FDA, EMA, etc.) and GCP, & ICH guidelines.  Knowledge or experience supporting regulatory or health authority inspections a plus.
• Experience leading and authoring clinical development inputs into regulatory submissions (IND, CTAs, NDA/BLAs, designation applications, etc.) and representing clinical development in agency interactions.
• Experience authoring and guiding teams with key asset and clinical trial level plans and documents.
• Strong knowledge in clinical development strategy, clinical trial design, regulatory pathways, biostatistics methodologies, and ability to analyze and interpret translational medicine, clinical, and research data as it relates to an asset, patients, etc.
• Possess excellent written and oral communication skills with internal and external stakeholders
• Proven ability to work collaboratively, take initiative, solve complex issues, and deliver results in a fast-paced, team-based matrix environment
• Demonstrate sound judgement in handling complex, confidential, and highly regulated information
• Ability and willingness to travel as required.

The annual base salary range for this level is $300,000.00 to $375,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Executive Director, Clinical Development role is a remote role based in the US, with occasional travel.

Description of Role

Centessa is seeking a Senior Scientist in Discovery DMPK to partner with pharmacologists and medicinal chemists to support the identification of lead candidates with optimal DMPK properties for potential progression into development. Reporting to the Executive Director, DMPK, this role requires understanding of pharmacokinetic (PK), pharmacodynamic/pharmacokinetic (PK/PD), and ADME principles to enable triaging & progression of small molecule leads. A qualified candidate will have previous experience in PK and PK/PD modeling, ideally for CNS drug candidates, and an understanding of vital ADME properties for CNS drug candidate progression.

Key Responsibilities

• Design profiling strategies (including in vitro ADME assays) to evaluate compounds and series emerging from hit identification effort
• Design PK/PD strategies to advance lead identification and optimization series
• Protocol development and data analysis of PK and PK/PD studies for proof-of-concept studies
• Review statements of work (SOWs) to ensure alignment with project objectives
• Analyze and interpret in vitro and in vivo PK and PK/PD data, ensuring accuracy and consistency
• Utilize AI tools in prediction of PK properties and guide the use of such technology in supporting SAR development in lead identification and optimization phases
• Author and review compound checklists for drug candidate progression
• Represent the DMPK function in project team meetings; present results and contribute to data-driven decision-making.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmacology or a related field
• Minimum of 4 years of industry experience in a biotech or pharmaceutical setting
• Proficiency with Phoenix WinNonlin and other software for PK and PK/PD modeling in small molecule drug discovery is essential
• Previous work in the early discovery and lead optimization of CNS drug candidates is essential
• Strong analytical and problem-solving skills
• Demonstrated ability to work cross-functionally and communicate scientific findings clearly and effectively
• Collaborative mindset and sense of urgency
• Proactive and excellent communication skills

Compensation

The annual base salary range for this position is $160,000 - $180,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa’s long-term success.

Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Sr. Scientist, DMPK is a remote role based in the US, with infrequent travel (~10%).

POSITION: Full-Time, Exempt

Description of Role

Centessa is seeking a short-term, contract Program Manager within the CMC group. The CMC PM will provide leadership and operational support to the development and manufacturing of our small molecule programs and actively engage with internal teams and external contract manufacturing organizations. Reporting to the Vice President, CMC, this individual will drive effective execution of CMC deliverables by the project teams in coordination with and support of program and corporate goals.  The ideal candidate should be highly organized and an exceptional communicator with experience leading early phase pre-IND teams through late-stage CMC Registration/Commercial validation and launch activities.

Key Responsibilities

• Serve as the main point of contact for all CMC project-related communications especially focused on drug product development, manufacturing, release, packaging, labeling, and stability coordination
• Foster strong relationships with internal teams, and external partners including CDMOs.
• Participate in regular telecon meetings with CDMOs to maintain the business relationship, progress, meeting notes and action items.
• Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel.
• Support CMC activities including tracking relevant GMP and Regulatory documentation.
• Interfaces with drug substance, drug product, analytical, non-clinical, clinical, Regulatory, supply chain, and Quality colleagues to ensure all projects are delivered on time, within scope and budget.
• Work with CMC team members to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth and/or company timelines.
• Cover all other project management requirements including shipment/logistics coordination, inventory, and production planning.
• Drive the development and management of detailed and integrated development plans for CMC projects that account for all phases of drug development across functions with timelines, work plans including interdependencies, gating items, budget, and risk management strategies.
• Oversee the delivery of project objectives per the program strategy, with a strong focus on meeting critical milestones, and managing scope changes while integrating project constraints.
• Facilitate effective collaboration across CMC functional teams, ensuring alignment on project goals and priorities.
• Communicate project updates consistently to various stakeholders, about strategy, adjustments, and development progress.
• Experience utilizing project management tools and best practices to support CMC activities.
• Excellent attention to detail, communication, time management, organizational skills, and flexible attitude to work assignments and new learning with proven ability to interact in a team environment.
• Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information.
• Project management professional (PMP) certification preferred.
• Expert MS Office skills including Excel, PowerPoint, MS Project, and other PM timeline software (e.g. Smartsheet).

Qualifications

• Bachelor's degree in scientific or related field; advanced degree in a scientific discipline preferred. 
• 10+ years of pharmaceutical industry experience, including 7+ years leading CMC project/program management activities
• Proven experience in small molecule drug development, with emphasis on drug product development and manufacturing
• Strong understanding of the end-to-end drug development process, including CMC, non-clinical, clinical, and regulatory activities
• Demonstrated knowledge of CMC requirements across all phases of clinical development
• Thorough understanding of cGMP regulations for pharmaceutical products
• Experience coordinating and managing CDMO activities supporting development and commercialization
• Strong project management, organizational, and prioritization skills to manage multiple, evolving programs
• Excellent decision-making, analytical, and resource management skills in dynamic, global environments
• Effective communicator with the ability to clearly convey complex scientific information both verbally and in writing
• Ability to work independently while collaborating cross-functionally and with stakeholders at all organizational levels
• Self-motivated, results-driven, adaptable to changing priorities, and willing to travel domestically and internationally

Compensation

The hourly range for this position is $90.00 to $120.00 per hour. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

Contractors engaged through Centessa are employed through a third-party agency that serves as the employer of record and provides access to a comprehensive benefits package. Eligible contractors may enroll in medical plans, including PPO and EPO options, as well as dental and vision coverage after 30 days. Additional perks, such as a 401(k), wellness programs, and other discounts, may also be available to eligible contractors. 

Work Location

The CMC Program Manager role is a remote role based in the US.

POSITION: Temporary, Non-Exempt