POSITION SUMMARY

We are looking for a Senior Director of CMC Project Management who is upbeat, organized, self-motivated, collaborative, detail-oriented, and has a strong technical background and knowledge base.  The person filling this player/coach role will partner with the Head of Tech Ops, Biologics to provide strategic and operational leadership to the brelovitug CMC program, overseeing the development and implementation of integrated CMC plans from PPQ campaigns through global regulatory submission, approval, commercial launch, and lifecycle management activities. This role requires being able to prioritize to meet both short-term and long-term goals. This is a fantastic opportunity to make an impact, wear many hats, and be a part of an exciting growing biotech company.  This position is located in Foster City.

JOB FUNCTIONS/RESPONSIBILITIES

• Manage program CMC budgets and related contracts, partnering with internal Finance and Contract functions.
• Serve as the primary business lead for external partners, ensuring technical transfers,  manufacturing campaigns, testing, and other externally sourced activities stay on schedule and within budget.
• Maintain dashboards and reporting mechanisms for program status, risks, decisions, and critical path updates for team and senior/executive leadership.
• Facilitate cross-functional communications to gather inputs, align priorities, resolve conflicts, and share project updates; ensure clarity of owners, deliverables, and deadlines.
• Maintain an integrated program timeline identifying critical decision points, governance reviews, team events, and key milestones.
• Partner with Program Project Management to ensure appropriate integration with overall product strategy, timelines, and reporting, including alignment between development activities and portfolio-level planning as needed.
• Support preparation for governance reviews and executive program presentations, ensuring materials are accurate, aligned, decision-oriented, and delivered on schedule.
• Drive disciplined change control and documentation of scope/timeline changes, ensuring impacts are understood and communicated to stakeholders.

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree; advanced degree (M.S., Ph.D, or MBA) preferred.
• At least 15+ years of work experience in the pharmaceutical/biotech industry with a significant focus on CMC project management for biologics.
• Experience managing relationships with biologics CDMOs.
• Able to effectively communicate updates, issues, and strategic solutions to problems.
• PMP (Project Management Professional) or equivalent accreditation is desired.

KNOWLEDGE, SKILLS, AND ABILITIES

• Strong interpersonal skills and ability to collaborate across functions; proven ability to influence without authority.
• Strong PM fundamentals (meeting management, timeline/critical path management, risk and issue management, decision tracking, action management, governance preparation).
• Proactive, forward-thinking, and able to anticipate needs in dynamic environments with competing priorities.
• Exceptional facilitation and communication skills (including executive-ready written and presentation skills) with success influencing at all levels cross-functionally.
• Strategic, able to identify long term needs and risks and to incorporate these into a long-term plan. Proven ability to make smart business decisions while balancing scientific, technical, and risk-based factors.
• Highly collaborative with outstanding relationship-building skills; ability to lead teams, navigate ambiguity, and resolve conflict effectively.
• Experience with project/portfolio management tools and systems and strong working knowledge of common collaboration tools (e.g., MS Office, Smartsheet, SharePoint).
• Willing to travel and to participate in teleconferences during non-business hours.

The salary range for this position is $270,000 to $300,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY

The Senior Manager, Bioanalytical will be responsible for all aspects of bioanalytical in the development and approval of Mirum rare disease assets.  As a key member of the small Clinical Pharmacology & Nonclinical Sciences group, the individual will represent these multiple functions on multidisciplinary drug development teams to define the strategy and oversee the execution of required studies/analyses through CROs to achieve team goals.

 JOB FUNCTIONS/RESPONSIBILITIES

• Serves as the bioanalytical lead on project and study teams, providing subject matter expertise on clinical development programs
• Leads the design and is responsible for the execution of nonclinical and clinical bioanalytical studies for all Mirum assets
• Manages collaborations with CROs and consultants, providing technical oversight as needed and ensuring timely and quality deliverables to fulfill project goals
• Leads the completion of the relevant sections of IND, NDA, MAA, other regulatory documents and works closely with Regulatory to support clinical document submission
• Provides CROs with technical oversight as needed and ensures that assay development, validations, sample analysis, and data transfers occur at CROs and in-house to meet project goals

QUALIFICATIONS

Education/Experience:

• BS in Biological Sciences and minimum of 6-8 years of relevant experience, or an advanced degree (MS, PhD) with fewer years of experience
• Prior experience with assets in liver, neurology, or rare disease indications is a plus
• Prior hands-on laboratory experience operating LC-MS/MS systems (or other quantitative instrumentation) and conducting sample preparation and analysis

 Knowledge, Skills and Abilities:

• Strong knowledge of GLP/GCLP compliance in supporting nonclinical and clinical studies
• Solid project management skills: ability to create and manage project plans, budgets, and schedules
• Strong communication skills (written and verbal) and interpersonal skills with an ability to communicate to people at all levels of the organization
• Functions efficiently, effectively and at times independently
• Proven track record of success as both an individual contributor and a collaborative team member
• Experience coordinating studies through CROs
• Recognized for being self-directed, well-organized, flexible, and detail-oriented; able to complete multiple activities while maintaining quality

 The salary range for this position is $200,000 to $220,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSTION SUMMARY

 The Clinical Trial Manager will support the overall management and coordination of operational activities involved in the planning, conduct and completion of clinical trials including the management of deliverables, adherence to budget, and ongoing risk mitigation. The CTM will support the management of selected CROs and help lead cross-functional study. teams to ensure the trial is completed on time, within budget, and with high quality.

 JOB FUNCTIONS/RESPONSIBILITIES

 General:

• Drive the planning, development and execution of timelines, while identifying and tracking the team's critical path.
• Facilitate the project team kick-off meeting by identifying key stakeholders and resources.
• Execute and control project activities, including scope, schedule, budget and risk associated with each assigned project and report performance to senior management.
• Help support the establishment of communication plans for information distribution to team members.
• Support study meetings.
• Support the Clinical Operation’s lead in the reviews at significant milestones or gates to evaluate successes as compared to baseline estimates.
• Identify and track key study metrics to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed).

Clinical:

• Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents.
• Assist with IND/CTA submission preparation.
• Support the development of plans and execution of those plans related to site monitoring, safety management, data management and biostatistics.
• Help the Clinical Operation Lead in identifying, evaluating, and selecting external vendors (central lab, CROs, consultants/contractors).
• Train and manage CROs and other clinical vendor activities to ensure the quality meets Mirum and regulatory requirements. 
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance. Develops/reviews and approves study plans.
• Support the development of contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract.
• Support the identification, selection and proper initiation of sites.
• Help develop patient recruitment strategies to ensure goals are achieved
• Support the development of CRFs, and clinical databases, support development of safety databases, and shell Tables, Figures and Listings.
• Plan and coordinate investigator meetings.
• Plan, coordinate and conduct Data Monitoring Committee (DSMC) meetings.
• Oversee timely database freeze and database lock. Participate in data review meetings.
• Oversee maintenance of the Trial Master File for each study and conduct periodic QC reviews of the TMF to ensure quality.
• Ensure adherence to SOPs, Good Clinical Practice and FDA/ICH regulations.

 QUALIFICATIONS

Education/Experience:

• Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework or certifications in clinical trial planning and operations desired.
• At least 5 years of relevant experience with project management and clinical development.
• Experience in liver disease is a plus.
• Experience in small, fast-paced biotech is a plus.
• Experience working in a fully outsourced model is a plus.
• Demonstrated experience coordinating interdepartmental activities and efforts to meet protocol and program goals.
• Expert and extensive knowledge of CRO / vendor management and global protocol operations.

Knowledge, Skills and Abilities:

• Must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
• Proficiency in resource planning and financial management (clinical trial budgeting) required.
• Ability to deal with multiple priorities with aggressive timelines.
• Strong oral and written communication skills.
• Strong social skills to build relationships with Investigators and site staff
• Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/elevate problems in a timely manner.
• Ability to find creative solutions to issues impacting timelines and budgets.

Work Environment:

• This is a high growth, fast paced organization. The ability to be productive and successful in a fast paced work environment is critical.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10% of work time.

The salary range for this position is $160,000 to $180,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY

The Executive Director, Clinical Development will join the Clinical Development group and will be responsible for all clinical trial related activities in all stages of clinical development in a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development, support study startup, oversight of trial execution, recruitment, ongoing clinical development management and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis, are required. Participation in health authority meetings and regulatory filing activities are also part of this role. The Director, Clinical Development, operates in collaboration with other functions including internal Safety and Clinical Operations teams.

JOB FUNCTIONS/RESPONSIBILITIES

• Leadership and management of all aspects of complex, global development clinical study program(s), from phase 1 through registration globally.
• Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate integration of clinical/regulatory strategy into global product development strategy.
• Primary liaison for internal Clinical Operations for site selection, site start-up activities, study management and closeout activities, etc.
• Support the creation of and/or review of clinical slides for internal and external meetings (i.e. Investigator Meetings, SIVs, Advisory Boards, etc.)
• Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc.
• Responsible for medical monitoring of efficacy and safety clinical trial data
• Strategic input on the overall development plan, internal and external evaluation of new indications and studies
• Oversight of medical aspects of compliance of and inspection readiness in completed, ongoing and starting clinical trials
• Collaboration in the analysis and writing of scientific publications/presentations
• Works closely with other functions, in particular with Safety function and Clinical Operations
• Co-leads Study Management Team with Clinical Operations lead.

QUALIFICATIONS

Education/Experience:

• MD, with a minimum of ≥5years. 
• Experience in rare disease.
• Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.

KNOWLEDGE, SKILLS

• Demonstrated accountability for delivery on complex development plans.
• Leadership in clinical development programs and multidisciplinary trial teams.
• Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.
• Ability to understand and communicate risks, as well as develop and execute contingency plans.
• Experience presenting data to regulatory agencies and advisory committees.
• Ability to think creatively and develop and execute in a fast-paced environment.
• Detail oriented with exceptional organizational skills.
• Effective communicator with strong verbal and written skills.
•  Ability to identify issues, analyze situations and provide effective solutions.
• Solid understanding of the clinical development process.
• Knowledge of applicable regulatory guidance.

Work Environment:

• This is a high growth, fast paced organization. The ability to be productive and successful in a work environment is critical.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 30% of work time.

The salary range for this position is $375,000 to $420,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY

The Director of Clinical Pharmacology will be responsible for all aspects of clinical pharmacology in the development and approval of Mirum rare disease assets.  As a key member of the small Clinical Pharmacology & Nonclinical Sciences group, the individual will represent these multiple functions on multidisciplinary drug development teams to define the strategy and oversee the execution of required studies/analyses through CROs to achieve team goals.

JOB FUNCTIONS/RESPONSIBILITIES

• Serves as the clinical pharmacology lead on project and study teams, providing subject matter expertise on clinical development programs
• Leads the design and is responsible for the execution of the clinical pharmacology strategy (from study design, planning, and oversight to data analysis, interpretation, and reporting) in support of key decisions/milestones (e.g., dose selection)
• Manages collaborations with CROs and consultants, providing technical oversight as needed and ensuring timely and quality deliverables to fulfill project goals
• Leads the authoring of clinical pharmacology sections of regulatory documents (clinical study protocol, CSR, Investigator’s Brochure, IND, NDA, MAA, briefing materials, response to queries)
• Plays a key role in due diligence efforts for potential drug in-licensing or partner opportunities, including review of existing data and development of clinical pharmacology strategy

QUALIFICATIONS

• Prior experience with assets in liver, neurology, or rare disease indications is a plus
• Experience with various therapeutic modalities (small molecule, antibody, ADC)

Education/Experience:

• BS in Biological Sciences with 12-15+ years or an advanced degree (PhD, PharmD) with 10+ years of experience in clinical pharmacology

Knowledge, Skills and Abilities:

• Proficiency in the design, execution, and interpretation of clinical pharmacology studies, including PK and PD assessments
• Thorough understanding of clinical pharmacology requirements, including regulatory guidance, to support drug development
• Proven track record of success as both an individual contributor and a collaborative team member
• Experience authoring and supporting regulatory filings (IND, NDA, MAA)
• Experience coordinating studies through CROs
• Solid knowledge of GCP compliance in supporting clinical studies
• Proficient in regulatory interactions both written and verbal
• Knowledge of PopPK, PBPK, exposure-response, or PK/PD modeling
• Solid project management skills: ability to create and manage project plans, budgets, and schedules
• Strong communication skills (written and verbal) and interpersonal skills with an ability to communicate to people at all levels of the organization
• Recognized for being self-directed, well-organized, flexible, and detail-oriented; able to complete multiple activities while maintaining quality

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POSITION SUMMARY

The Director/Senior Director, Clinical Development will be responsible for all clinical trial related activities for Brelovitug, a key asset in Phase 3 on a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development, support study startup, oversight of trial execution, recruitment, ongoing clinical development management and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis are required. Participation in health authority meetings and regulatory filing activities are also part of this role. The Director/Senior Director, Clinical Development operates in collaboration with other functions including internal Safety, Regulatory, Biometrics, and Clinical Operations teams.

JOB FUNCTIONS/RESPONSIBILITIES 

• Leadership and management of all aspects of complex, global development clinical studies.
• Primary point of contact for clinical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate integration of clinical/regulatory strategy into global product development strategy.
• Primary liaison for internal Clinical Operations for site selection, site start-up activities, study management and closeout activities, etc.
• Support the creation of and/or review of clinical slides for internal and external meetings (e.g. Investigator Meetings, SIVs, IDMCs, Advisory Boards, etc.)
• Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc.
• Strategic input on the overall development plan, internal and external evaluation of new studies
• Oversight of clinical aspects of compliance of and inspection readiness in completed, ongoing and starting clinical trials
• Collaboration in the analysis and writing of scientific publications/presentations
• Works closely with cross-functional team members
• Co-leads Study Management Team with Clinical Operations lead.

QUALIFICATIONS

Education/Experience:

• MD, PharmD, PhD or equivalent is preferred with ≥3 years of drug development in industry, academia, or a related environment, working within cross‑functional project or program teams with proven success.
• Experience in Liver or rare disease a plus.
• Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.

 Knowledge, Skills and Abilities:

• Demonstrated accountability for delivery on clinical studies.
• Leadership in clinical development programs and multidisciplinary trial teams.
• Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.
• Ability to understand and communicate risks, as well as develop and execute contingency plans.
• Ability to think creatively and develop and execute in a fast-paced environment.
• Detail oriented with exceptional organizational skills.
• Effective communicator with strong verbal and written skills.
• Ability to identify issues, analyze situations and provide effective solutions.
• Solid understanding of the clinical development process.
• Knowledge of applicable regulatory.

Work Environment:

• This is a high growth, fast paced organization. The ability to be productive and successful in a work environment is critical.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 20% of work time.

The salary range for this position is $220,000 to $240,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY

The Associate Director of Clinical Pharmacology will be responsible for all aspects of clinical pharmacology in the development and approval of Mirum rare disease assets.  As a key member of the small Clinical Pharmacology & Nonclinical Sciences group, the individual will represent these multiple functions on multidisciplinary drug development teams to define the strategy and oversee the execution of required studies/analyses through CROs to achieve team goals.

JOB FUNCTIONS/RESPONSIBILITIES

• Serves as the clinical pharmacology lead on project and study teams, providing subject matter expertise on clinical development programs
• Leads the design and is responsible for the execution of the clinical pharmacology strategy (from study design, planning, and oversight to data analysis, interpretation, and reporting) in support of key decisions/milestones (e.g., dose selection)
• Manages collaborations with CROs and consultants, providing technical oversight as needed and ensuring timely and quality deliverables to fulfill project goals
• Leads the authoring of clinical pharmacology sections of regulatory documents (clinical study protocol, CSR, Investigator’s Brochure, IND, NDA, MAA, briefing materials, response to queries)
• Plays a key role in due diligence efforts for potential drug in-licensing or partner opportunities, including review of existing data and development of clinical pharmacology strategy

QUALIFICATIONS

• Prior experience with assets in liver, neurology, or rare disease indications is a plus
• Experience in PopPK, PBPK, exposure-response, or PK/PD modeling is a plus

Education/Experience:

• BS in Biological Sciences with 7+ years or an advanced degree (PhD, PharmD) with 3+ years of experience in clinical pharmacology

Knowledge, Skills and Abilities:

• Proficiency in the design, execution, and interpretation of clinical pharmacology studies, including PK and PD assessments
• Thorough understanding of clinical pharmacology requirements, including regulatory guidance, to support drug development
• Proven track record of success as both an individual contributor and a collaborative team member
• Experience authoring and supporting regulatory filings (IND, NDA, MAA)
• Experience coordinating studies through CROs
• Solid knowledge of GCP compliance in supporting clinical studies
• Solid project management skills: ability to create and manage project plans, budgets, and schedules
• Strong communication skills (written and verbal) and interpersonal skills with an ability to communicate to people at all levels of the organization
• Recognized for being self-directed, well-organized, flexible, and detail-oriented; able to complete multiple activities while maintaining quality

The salary range for this position is $195,000 to $210,000 USD. Compensation will be determined based on several factors including but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY 

Lead for NonClinical and Clinical Pharmacology Functions at Mirum.

JOB FUNCTIONS/RESPONSIBILITIES

• Lead the design and execution of a nonclinical and clinical pharmacology development plan for all Mirum assets
• Develop resource plan via employees and vendors to enable nonclinical and clinical pharmacology development of Mirum assets
• Manage nonclinical team members and coordinate across functions to achieve nonclinical and clinical pharmacology goals
• Continually review and monitor guidance, regulations, and publications in nonclinical and clinical pharmacology development and relevant therapeutic areas
• Assess nonclinical safety findings for potential expedited safety reporting
• Provide input on clinical safety programs (informed consent, exclusion criteria, pregnancy, etc.) and clinical pharmacology programs (ADME, DDIs, PK/PD, BE, etc)
• Identify and work with expert consultants as needed to fill project needs
• Ensure the completion of the relevant sections of IND, NDA, MAA, other regulatory documents, and ensure robust responses for information requests
• Represent nonclinical and clinical pharmacology with regulatory agencies (responses to queries, preparation of pre-meeting documents, attend teleconferences and meetings with Health Authorities, as needed)
• Lead due diligence efforts for potential drug in-licensing or partner opportunities, including assessment and review of existing data and development of nonclinical strategy
• Provide expertise and execute non-clinical efficacy research for translation into clinical programs, including resourcing appropriate animal models and interpretation of results, in partnership with senior management team

QUALIFICATIONS 

Education/Experience:

• Advanced science degree (e.g. PhD, PharmD)
• Board certification in toxicology (DABT) preferred
• 10+ years leadership experience and 15+ years drug development experience

 Knowledge, Skills and Abilities: 

• Ability to understand and effectively communicate scientific information
• Thorough understanding of the nonclinical and clinical pharmacology requirements, including regulatory guidance, to support drug development in US and EU
• Deep knowledge of toxicology study design and interpretation, pharmacodynamics and pharmacokinetics modeling
• Extensive experience coordinating studies through CROs
• Extensive experience authoring and supporting regulatory filings (INDs, NDAs, MAA, DSURs, IBs, etc)

The salary range for this position is $300,000 to $330,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSTION SUMMARY

 The Senior Manager, Clinical Data Management will collaborate primarily with internal team members and external vendors to manage all data collection and data reporting aspects. In addition, the Senior Manager will lead the development of systems and procedures to assure consistency across the Clinical Data Management department.   Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals in accordance with Standard Operating Procedures (SOPs) and regulatory directives. Participate in staff recruitment, onboarding, training and mentoring. 

PRIMARY RESPONSIBILITIES

• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies, build effective relationships with CRO/vendor counterparts
• Able to review and provide feedback to the multi-disciplinary team on other study documents e.g. clinical study protocols, protocol deviation plans, medical monitoring plan, statistical analysis plan, mock Tables, Figures and Listings (TFL) shells and Clinical Study Reports (CSRs)
• Reviews and approves DM related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, Validation Plan, User Acceptance Testing (UAT) documentation, Data Review Plan, etc.
• Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting
• Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock
• Knowledge of standard coding dictionaries MedDRA, WHOdrug, etc., and related best practices
• Attends and represents CDM effectively on all assigned studies and programs at relevant meetings.
• Understand critical tasks and milestones; ensure data management deliverables are met per study timelines
• Manage the clinical study budget, ensuring the project remains within scope through reviewing and approving invoices, identifying out-of-scope activities and its appropriate handling
• Work collaboratively with biostatistics, programming and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
• Monitor in-house resources of assigned projects and identify potential deficiencies; work with supervisor to develop and implement a plan to overcome any obstacles
• Contribute to developing and implementing departmental policies, standards and process improvement initiatives as needed
• Support implementation of data standards
• Align with and support management and corporate goals or objectives
• Contribute to activities supporting audits & inspection readiness and regulatory inspections
• Assist in selecting vendors/CROs e.g. reviewing RFIs/RFPs and participating in bid defenses
• Identify, manage, mentor and develop Clinical Data Management team members
• Good working knowledge of medical/scientific terminology and knowledge of ICH guidelines and regulations relating to data management activities

QUALIFICATIONS

Education/Experience

• Bachelor’s Degree preferably in a scientific or health-related discipline; Master’s degree is a plus
• 8+ years of clinical data management experience in a pharmaceutical/biotech setting

Knowledge, Skills and Abilities

• Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives
• Experience in managing outsourced clinical data management activities and/or other vendors
• Thorough understanding of the drug development process, clinical trial methodology, regulatory requirements, ICH, GCP and GCDMP
• Current and extensive knowledge of industry CDM best practices and processes
• Strong experience with various clinical database management systems including EDC, eCOA, and ePRO
• Strong and effective oral and written communication, project management, and interpersonal skills
• Proven success working in a virtual, global and multi-cultural environment
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Proven success in identifying creative solutions to complex study-related or technical issues
• Knowledge of SAS, EDC programming, systems integration experience
• Solid understanding of CDASH and CDISC standards
• Ability to mentor junior staff

The salary range for this position is $185,000 to $205,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY

The Associate Director, Program Management plays a central role within Mirum by providing program management expertise and ensuring cross-functional planning and execution. The program manager partners with the Program Lead and functional leads to develop and manage the integrated product plan, develop timelines, and ensure adherence to the budget for one of our pipeline programs. 

JOB FUNCTIONS/RESPONSIBILITIES

• Support the Program Lead with the development, communication, and timely execution of the program strategy
• Organize and drive effective and action-oriented program team meetings by preparing and distributing agendas/minutes, identifying and tracking decisions and action items to resolution, and escalating areas of concern as needed
• Partner with the Program Lead to facilitate effective cross-functional decision making with transparent communication and clear escalation pathways
• Facilitate identification of risks which could impact the program’s strategic goals; propose and implement plans to mitigate risks or develop contingencies
• Develop and maintain integrated program timelines in conjunction with functional leads
• Identify and communicate program priorities, interdependencies, and critical path activities to all stakeholders to allow long term planning, including resource allocation
• Organize the preparation of high-quality documents for review by governance committees in collaboration with the Program Lead and program team
• Prepares and provides project documents and information for monthly reports, executive team updates, and board meetings.
• Partner with Program Lead and finance and accounting to develop annual operating plan components related to assigned program and support budget management by timely identification of out-of-scope activities
• Coordinate and manage special program-related projects, as assigned
• Contribute to the standardization of project management best practices at Mirum

 QUALIFICATIONS

Education /Experience:

• Bachelors Degree or higher in scientific/healthcare/business field
• Experience (7+ years) in clinical research and project management within the pharmaceutical industry (Biotech/small pharma experience preferred).
• Experience in rare disease and/or liver disease is a plus.

Knowledge, Skills and Abilities:

• Strong ability to communicate effectively with team members creating an environment that fosters successful teamwork, collaboration and cooperation.
• Thorough understanding of clinical trial management processes and the operation of all clinical development functional areas.
• Demonstrated ability to prepare timelines and present related information to management.
• Proven ability to identify risks, propose mitigation strategies, and remove barriers to success.
• Strong attention to detail and the ability to work collaboratively with Project Lead to establish priorities for team.
• Expertise in developing and managing project scope, deliverables, risks and resource requirements.
• Strong knowledge of project management software packages and the Microsoft Office Suite: Excel, Project, PowerPoint, Word and Outlook; ability to create effective presentations for internal and external use.
• Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands, across time-zones, while maintaining positive attitude.
• Ability to work independently, take initiative, complete tasks to deadlines and support product team in doing the same.
• Excellent written and oral communication skills.
• Displays a high level of professionalism with internal and external stakeholders.
• Knowledge of current regulatory requirements and guidelines governing clinical research. (e.g. ICH/GCP).

The salary range for this position is $195,084 to $225,217 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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