Senior Medical Affairs Operations Manager
Crinetics Pharmaceuticals
3 months ago
Remote friendly (United States)
United States
$147,000 - $184,000 USD yearly
Medical Affairs
Position Summary
- Manage the execution of medical affairs operations, investigator initiated clinical studies, post-marketing clinical studies, and post-trial access programs.
- Oversee review, monitoring, and adherence to clinical protocols; independently own key projects.
- Interact with cross-functional study teams; may supervise more junior managers/assistants.
Responsibilities
- Oversee clinical affairs programs across the drug development process, including post-trial access programs for continued investigational product provision per regional regulations.
- Provide operational and strategic input for expanded access programs and study documents (e.g., synopses, protocols, ICFs, CRFs, completion guidelines, execution plans, clinical data review plans, database edit specifications, CSR development).
- Coordinate and lead study team meetings; provide stakeholders updates on progress, timelines, budget, and milestones.
- Develop subject recruitment/retention strategy.
- Oversee TMF setup, quality review, and final reconciliation of study documents (including site regulatory documents/packages and site insurance).
- Develop training materials for program team, sites, and vendors.
- Proactively manage information sharing via standardized reports.
- Ensure compliance with ICH/GCP and applicable regulations.
- Oversee RFP preparation and bid templates to select CROs/vendors (and/or supervise collaboration).
- Collaborate with counsel to negotiate/draft CRO/vendor and clinical site contracts.
- Liaison with Regulatory Affairs to ensure GCP adherence, SOP maintenance, and completion of site/CRO/vendor audits.
- Perform study risk management and implement mitigations.
- Identify program issues and recommend/implement solutions or corrective actions.
- Create realistic plans with goals, milestones, responsibilities, and results; make timely data-driven decisions.
Required Qualifications
- Bachelor’s degree (preferably scientific); equivalent education/experience acceptable.
- 8+ years clinical operations experience managing clinical trials (preferably CRO/small biotech); 5+ years supervisory experience.
- Proficiency with Microsoft Office, electronic TMF systems, IRT, and EDC systems.
- Excellent understanding of the drug development process.
- Ability to make decisions to move projects forward.
- Strong verbal and written communication skills.
- Experience with data flow from sites through data processing, review, and resolution.
- Ability to analyze and generate reports.
- Understanding of FDA regulatory requirements (e.g., GCPs, CFRs).
- Ability to handle multiple tasks and meet deadlines.
- Experience with study initiation procedures.
- Ability to exercise judgment to determine appropriate action.
Preferred Qualifications
- Experience in rare disease and/or oncology.
Benefits (if applicable)
- Base pay: $147,000–$184,000.
- Discretionary annual target bonus; stock options; ESPP; 401k match.
- Medical, dental, vision, and basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.
Work Conditions / Other
- May require travel up to 10% of the time.
- Continuous desk work; intermittent phone and keyboard/written communications; some walking and lifting up to 25 lbs.
- If applicable: biology/chemical laboratory environment; environmental health and safety requirements.
- Manage the execution of medical affairs operations, investigator initiated clinical studies, post-marketing clinical studies, and post-trial access programs.
- Oversee review, monitoring, and adherence to clinical protocols; independently own key projects.
- Interact with cross-functional study teams; may supervise more junior managers/assistants.
Responsibilities
- Oversee clinical affairs programs across the drug development process, including post-trial access programs for continued investigational product provision per regional regulations.
- Provide operational and strategic input for expanded access programs and study documents (e.g., synopses, protocols, ICFs, CRFs, completion guidelines, execution plans, clinical data review plans, database edit specifications, CSR development).
- Coordinate and lead study team meetings; provide stakeholders updates on progress, timelines, budget, and milestones.
- Develop subject recruitment/retention strategy.
- Oversee TMF setup, quality review, and final reconciliation of study documents (including site regulatory documents/packages and site insurance).
- Develop training materials for program team, sites, and vendors.
- Proactively manage information sharing via standardized reports.
- Ensure compliance with ICH/GCP and applicable regulations.
- Oversee RFP preparation and bid templates to select CROs/vendors (and/or supervise collaboration).
- Collaborate with counsel to negotiate/draft CRO/vendor and clinical site contracts.
- Liaison with Regulatory Affairs to ensure GCP adherence, SOP maintenance, and completion of site/CRO/vendor audits.
- Perform study risk management and implement mitigations.
- Identify program issues and recommend/implement solutions or corrective actions.
- Create realistic plans with goals, milestones, responsibilities, and results; make timely data-driven decisions.
Required Qualifications
- Bachelor’s degree (preferably scientific); equivalent education/experience acceptable.
- 8+ years clinical operations experience managing clinical trials (preferably CRO/small biotech); 5+ years supervisory experience.
- Proficiency with Microsoft Office, electronic TMF systems, IRT, and EDC systems.
- Excellent understanding of the drug development process.
- Ability to make decisions to move projects forward.
- Strong verbal and written communication skills.
- Experience with data flow from sites through data processing, review, and resolution.
- Ability to analyze and generate reports.
- Understanding of FDA regulatory requirements (e.g., GCPs, CFRs).
- Ability to handle multiple tasks and meet deadlines.
- Experience with study initiation procedures.
- Ability to exercise judgment to determine appropriate action.
Preferred Qualifications
- Experience in rare disease and/or oncology.
Benefits (if applicable)
- Base pay: $147,000–$184,000.
- Discretionary annual target bonus; stock options; ESPP; 401k match.
- Medical, dental, vision, and basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.
Work Conditions / Other
- May require travel up to 10% of the time.
- Continuous desk work; intermittent phone and keyboard/written communications; some walking and lifting up to 25 lbs.
- If applicable: biology/chemical laboratory environment; environmental health and safety requirements.