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Centessa Pharmaceuticals, LLC

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23 open rolesTeam 51-200Latest: May 4, 2026, 7:33 PM UTC
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Role Description 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. Requirements - 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 a remote role based in the US, with occasional travel. EEOC Statement Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

United States
$285K - $350K / year
Job Closed

Role Description 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. The 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). - 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. Benefits - 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: - 401(k) plan - Company-sponsored medical, dental, vision, and life insurance - Generous paid time off - Health and wellness program Work Location The Executive Director, Clinical Development role is a remote role based in the US, with occasional travel. EEOC Statement Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

United States
$300K - $375K / year

Role Description The Vice President, Global Medical Safety / Pharmacovigilance will serve as the global leader for drug safety, providing strategic vision and medical oversight across all pharmacovigilance and risk management activities. This role is responsible for leading pre- and post-marketing safety activities across all phases of clinical development (Phase I–IV) and post-approval, ensuring proactive benefit–risk assessments, regulatory compliance, and the highest standards of patient safety. The VP will drive an integrated, science-driven global safety strategy for the company’s small molecule pipeline, working closely with internal stakeholders and teams, as well as global health authorities. In addition, this role will oversee departmental operations, including organizational planning, budgeting, and the development of scalable pharmacovigilance capabilities to support a growing biotech organization. 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. Qualifications - Medical Degree (MD) in a life science–related field is required. - 15+ years of pharmacovigilance experience in the biopharmaceutical industry, including 10+ years in senior leadership roles. - Demonstrated experience supporting CNS drug development programs across clinical and post-marketing stages. - Extensive experience in small molecule drug development (Phase 1–Phase 4). - Proven track record of effective interactions with global health authorities on safety-related matters. - Deep understanding of global pharmacovigilance regulations, GVP, and ICH guidelines. - Demonstrated ability to lead safety risk management strategies, signal detection, and benefit–risk assessments. - Experience leading cross-functional safety teams and influencing stakeholders in a fast-paced biotech environment. - Expertise in clinical trial safety oversight, post-marketing pharmacovigilance, and regulatory safety submissions. - Strong analytical judgment, decision-making, and problem-solving capabilities. - Excellent written and verbal communication skills with the ability to engage senior internal and external stakeholders. - Ability to thrive in a dynamic, high-growth organization. Requirements - 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. - 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 a remote role based in the US, with occasional travel. EEOC Statement Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

United States
$350K - $380K / year
Job Closed

Role Description Centessa is seeking a 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 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 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+ 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 this position is $120,000 - $150,000. 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 Clinical Trial Manager is a remote role based in the US, with occasional travel (10% - 15%). EEOC Statement Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

United States
$120K - $150K / year
Job Closed

Role Description 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 Requirements - 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 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 Senior Director, Clinical Pharmacology role is a remote role based in the US, with occasional travel. EEOC Statement Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

United States
$270K - $295K / year

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. 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 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 - 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) preferred - 15+ years of experience in pharmaceutical or biotechnology R&D with a strong track record in nonclinical and regulatory toxicology - Deep expertise supporting small‑molecule programs across discovery, IND‑enabling, and early clinical development - 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 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 Executive Director, Head of Toxicology role is a remote role based in the US, with occasional travel. POSITION: Full-Time, Exempt EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

United States
$320K - $350K / year

Role Description 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 Requirements - 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. - This role is eligible for a discretionary annual bonus and participation in our equity program. Benefits - Comprehensive benefits package, which includes a 401(k) plan - Company-sponsored medical, dental, vision, and life insurance - Generous paid time off - Health and wellness program Work Location - The Sr. Scientist, DMPK is a remote role based in the US, with infrequent travel (~10%). EEOC Statement Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

United States
$160K - $180K / year
Job Closed

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Description of Role The Sr. Clinical Trial Associate (Contractor) will perform tasks to support the planning and execution of clinical studies across one or more clinical trials. This position will work closely with the Clinical Trial Manager (CTM) to ensure site start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs), GCP and regulatory guidelines. Key Responsibilities - Assists and provides support to the CTM and study team in the day-to-day operational management of assigned clinical trials. - Supports the CTM in coordination, preparation, and documentation of internal and external meetings such as Kick-Off Meetings, Investigator Meetings, and vendor management meetings by preparing agendas, minutes, and presentation materials, organizing meeting logistics and travel arrangements if necessary. - Take responsibility for meeting logistics, agendas, and minutes of the clinical study team in accordance with standards. - Assist with tracking of purchase orders and invoices, site budgets, investigator payments, CTAs, etc. - Assists in tracking key site metrics and milestones such as Site Initiation Visits and site activation, subject recruitment and enrollment, critical study dosing days and assessments, scheduled Monitoring Visits and Close-Out Visits etc. - Contribute to study level tracking by maintaining tools to track assignment and training of study team members, recruitment materials and compliance tools, laboratory kits, samples and study supplies, vendor portal access, etc. - Support the CTM in the oversight of study vendors; including review of invoices. - Supports the CTM and contributes to the review of clinical documentation such as Informed Consent (ICF), Study Reference Binder, Study Management Plans, Monitoring plan, study protocols etc. - Manages and maintains the study team SharePoint - Assists in clinical site oversite, data entry timeliness, review of monitoring trip reports and tracks resolution of all action items. - Assists in TMF management to ensure it is being maintained up-to-date and all essential documents are appropriately filed in the TMF. - Assist CTM and study team in the review and cleaning of study data in preparation for database lock. Qualifications - B.A. or B.S. degree required. - 4+ years' experience within a biotech or pharmaceutical organization with at least 2 years in clinical operations. - Experience working with clinical sites, principal investigators, clinical operations staff and CROs a plus. - Knowledge and training on Good Clinical Practice (GCP) for clinical research studies. - Computer skills should include proficiency with Microsoft Office software, specifically, Outlook, Word, and Excel. - Independently motivated, detail oriented and good problem-solving ability. - Excellent written and verbal communication skills. - Flexible and able to adapt to new situations as the business demands. - Ability to work effectively from a virtual home office setting. - Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones. - Occasional travel may be required to attend investigator meetings, site visits, and/or professional conferences. Amount of travel required is study-specific. Compensation The hourly rate for this position is $65.00 to $75.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. This position is a contract role and is not eligible for company employee benefits, including but not limited to health insurance, retirement plans, paid time off, or other employee programs. Individuals engaged in this role will be employed by and receive compensation through Centessa's designated employer of record. Work Location The Sr. Clinical Trial Contractor is a remote role based in the US POSITION: Temporary, Non-Exempt EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

United States
$65 - $75 / hour

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Description of Role Centessa is seeking a Director of Program Management 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. Travel to vendors both domestically and internationally will be required. 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 annual base salary range for this position is $185,000.00 to $240,000.00. 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 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 Director CMC Program Management role is a remote role based in the US, with domestic and international travel. POSITION: Full-Time, Exempt EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

United States
$185K - $240K / year

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. 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 he 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 $250,000.00 to $300,000.00. 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 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 Senior Director, Analytical Development, CMC (Small Molecule) role is a remote role based in the US, with travel. POSITION: Full-Time, Exempt EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

United States
$250K - $300K / year

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