CultureHQ

Manager

• Respond to and oversee timely, accurate, and balanced responses to unsolicited medical information inquiries from healthcare professionals, patients, caregivers, and internal stakeholders
• Serve as a medical information subject matter resource for assigned products and disease states
• Partner with outsourced medical information call center/vendor to support inquiry fulfillment, training, escalation management, quality monitoring, and issue resolution
• Manage the Medical Information (MIC) database from a system and operations standpoint, including oversight of user access, workflow configuration, data quality, reporting needs, and system-related documentation
• Partner with the medical information database/system vendor to identify, track, and resolve system bugs, fixes, enhancements, and other operational needs that support compliant and efficient inquiry management
• Serve as a liaison with the outsourced call center to triage and resolve operational issues as they arise, including system access, workflow questions, inquiry routing, documentation, and escalation processes
• Support development, implementation, and continuous improvement of Medical Information processes, work instructions, and operational standards to ensure consistency, compliance, and efficiency
• Ensure appropriate identification and reporting of adverse events (AEs), product quality complaints, and special situations in partnership with Pharmacovigilance and the Quality team
• Develop, review, update, and maintain standard response documents (SRs), reactive materials (including payor materials), and scientific response content for approved and pipeline products
• Research, analyze, and interpret scientific literature to support custom medical responses and scientific exchange
• Lead and/or support development of custom responses for complex or escalated medical inquiries
• Maintain version control and ensure medical information content remains current, scientifically balanced, and compliant
• Collaborate with Medical Affairs, Clinical Development, Regulatory, Legal/Compliance, Commercial, Market Access and Safety colleagues to support aligned and compliant medical information practices
• Contribute medical information insights and trends to support Medical Affairs strategy and customer understanding
• Ensure activities comply with FDA regulations, company SOPs, and industry standards governing unsolicited medical requests and scientific exchange
• Support Medical/Legal/Regulatory (MLR) review activities as needed and develop understanding of promotional and non-promotional review processes

Senior Manager, Medical Information

Medical Director

• In collaboration with the Head of Clinical Development, provide strategic and medical leadership for the bezuclastinib clinical development program in GIST
• Provide clinical and medical support to life cycle management activities in GIST as needed
• Collaborate with commercial and medical affairs colleagues to support launch activities for bezuclastinib in GIST
• Provide primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation for the Peak clinical trial
• Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, good clinical practice (GCP) and good medical practice
• Work collaboratively with matrix team members in trial execution and oversight
• Provide support to the clinical trial study team to manage safety, site education, protocol-related and eligibility questions
• Provide medical oversight and input into clinical trial documents including but not limited to the study protocol, informed consent form (ICF), statistical analysis plan (SAP), case report form (CRF), clinical study report (CSR)
• Provide medical and scientific input into other documents including but not limited to the investigators’ brochure, regulatory filings and submissions, abstracts, manuscripts and publications, clinical study reports
• Collaborate with the regulatory team to develop briefing documents and other regulatory documents in support of submissions
• Interact with clinical trial sites, external clinical experts, contract research organizations (CROs) and regulatory agencies
• Support investigator meetings, steering committee meetings, data monitoring committee reviews as the study physician
• Assist with regulatory submissions by answering protocol-related questions from regulatory authorities, ethics committees and institutional review boards (IRBs)
• Develop a deep understanding of the clinical and competitive environment and work with the asset team to develop the target product profile

Senior Medical Director

QA Engineer

• Provide scientific leadership for QC GMP activities, including method transfer, qualification, validation, and lifecycle management for drug substance (DS) and drug product (DP).
• Serve as a QC subject-matter expert supporting release and stability testing, including data review, trending, and interpretation.
• Lead or support investigations of deviations, OOS, and OOT results, including root cause analysis and development of corrective and preventive actions (CAPAs).
• Collaborate closely with Analytical Development and CMC teams to ensure successful method transfers to QC laboratories and external CMOs.
• Provide oversight of QC activities conducted at contract testing laboratories and manufacturing partners, including review of data packages and ensuring compliance with quality and regulatory requirements.
• Contribute to the development and execution of control strategies for small-molecule drug substance and drug product.
• Author, review, and approve QC-related documents, including methods, specifications, protocols, validation reports, and regulatory submission content.
• Support regulatory inspections and audits, including preparation, response, and follow-up activities.
• Identify opportunities for continuous improvement in QC processes, technologies, and compliance practices.
• Mentor junior staff and serve as a technical resource across functional teams.

Senior Manager, Quality Assurance GMP

• Provide strategic leadership and oversight for GCP quality assurance activities supporting clinical development programs.
• Lead the development, planning, and execution of GCP audits, including audits of clinical sites, CROs, vendors, and internal processes.
• Own and drive regulatory inspection readiness, including preparation for FDA and other health authority inspections, inspection conduct, and response to findings.
• Collaborate with Clinical Development and Clinical Operations teams to ensure studies are conducted in compliance with applicable GCP, regulatory requirements, and company SOPs.
• Provide expert guidance in the identification, investigation, and resolution of quality events, including deviations, CAPAs, and audit findings.
• Oversee and maintain the GCP quality systems, including processes for audit tracking, issue management, and quality metrics.
• Contribute to the development, implementation, and continuous improvement of quality systems, SOPs, and policies to support GCP compliance.
• Support cross-functional teams in the preparation and review of clinical documents and regulatory submissions from a quality perspective.
• Manage relationships with external vendors and partners to ensure quality expectations are clearly defined and met.
• Provide mentorship and guidance to junior QA staff and serve as a key quality resource across the organization.

Associate Director, Quality Assurance, GCP

Director

• Subject matter expert for all aspects of drug substance process and controls.
• Manage development and manufacturing activities at drug substance CDMOs.
• Lead small molecule drug substance route selection/evaluation, scale up, and process control development including identification of critical process parameters, critical quality attributes, and acceptance criteria.
• Review and approve external vendor documentation including protocols, reports, raw data, master and executed batch records.
• Perform impurities fate analysis and manufacturing process parameters assessment and develop an overall end-to-end control strategy.
• Lead solid state evaluation and development activities to support process control, formulation development, and intellectual property protection.
• Provide drug substance support for quality events including deviation investigation, corrective and preventative action implementation and change control for both internal and external operations.
• Author, review, and approve documents in support of regulatory filings including module 3 sections of Investigational New Drug (IND) applications and New Drug Application (NDA) as well as CMC section in a global regulatory submission.
• Provide guidance as a subject matter expert in drug substance manufacturing and development for internal CMC and discovery organization.
• Provide on-site support at external suppliers including project initiation, routine visits and technical leadership as needed.

Director, Drug Substance Manufacturing – Development

General

• Manage the assigned territory as a scientific and medical expert in GIST and Systemic Mastocytosis.
• Help shape marketing strategy by translating complex scientific data into actionable clinical insights, identifying unmet needs through KOL engagement, and mapping the therapeutic landscape to guide product positioning.
• Support strategic priorities developed in collaboration with Medical Affairs and Patient Advocacy, aligned with corporate goals and ongoing clinical development and commercialization activities.
• Develop and execute a territory strategy aligned with regional business objectives while ensuring compliant, accurate, data-driven scientific exchange.
• Lead scientific engagement with thought leaders, subject matter experts, investigators, and HCPs to gather insights on clinical practice, scientific developments, and competitive trends. Cultivate peer-to-peer relationships with top-tier scientific and medical experts (KOLs).
• Build and maintain a strong network of experts; implement thought-leader development plans; increase awareness of Cogent, bezuclastinib, and the pipeline.
• Facilitate investigator-initiated research and real-world evidence proposals aligned with the Lifecycle Management Team.
• Monitor competitive activities and trends; communicate insights across U.S. and global teams.
• Lead onboarding and ongoing training for new Medical Affairs, Commercial, and cross-functional colleagues.

Senior Medical Science Liaison – West Region

• Strategically plan and engage within the assigned territory as a scientific and medical expert in GIST and Systemic Mastocytosis
• Help shape marketing strategy by translating complex scientific data into actionable clinical insights
• Support strategic priorities developed in collaboration with Medical Affairs and Patient Advocacy
• Develop and implement a territory strategy aligned with regional business objectives
• Lead scientific engagement with thought leaders, subject matter experts, and HCPs
• Build and maintain a strong network of experts
• Facilitate investigator-initiated research and real-world evidence proposals
• Support the Market Access team in delivering educational programs as needed
• Support Clinical Development to identify clinical trial sites as needed
• Collaborate with Research and Scientific Affairs to identify and engage KOLs
• Demonstrate proactive, innovative thinking to support regional and corporate objectives
• Maintain required training and adhere to all compliance standards
• Develop and implement educational outreach strategies
• Support scientific congresses through booth staffing and meeting coordination
• Monitor competitive activities and trends; communicate insights across teams
• Lead onboarding and ongoing training for new colleagues
• Foster a collaborative, innovative culture
• Complete administrative tasks accurately and on time
• Travel up to approximately 80% within the assigned territory