The Role

Mineralys is seeking a Sr. Manager/Associate Director, Program Management to help drive sub-team(s) forward in the development of a highly selective aldosterone synthase inhibitor for the treatment of uncontrolled hypertension. The Sr. Manager/ Associate Director, Program Management will work in close collaboration with the Director, Program Management, Clinical Operations, and cross functional team to enable the execution of corporate strategy and goals. A successful candidate will have program management experience, clinical operations experience, and a strong ability to function in an ambiguous and fast paced work environment.

What you will do:

• Conduct sub-team meetings to review, track and coordinate project milestones and activities, as well as collaborate on and communicate program details, risks and mitigations. Ensure that all team members understand project goals, objectives and strategic value, the project plan/schedule, and critical path activities both at their individual/functional level as well as for the overall project.

• Facilitate cross-functional team meetings, support decision making, prepare agendas and meeting minutes, and define/resolve action items.

• Build and manage clinical timelines in alignment with corporate strategy and corporate goals, including scenario planning and problem solving. Support the cross-functional team in execution of the plan, and track progress.

• Proactively identify and escalate potential issues, gaps and challenges. Collaborate with the cross functional team to identify mitigations, and drive resolution of issues and project impediments.

• Prepare project status updates and similar presentations for Management, including progress against plans, emerging issues, risks, and mitigations

• Collaborate with Finance and Clinical Operations to coordinate resource planning and budget across clinical studies.

• Utilize a variety of project management tools, systems, software and techniques to support the development and scaling of high-performing cross functional teams and contribute to project management methodologies

What you will bring:

• Bachelor’s Degree in Life Sciences

• Minimum 5 years’ experience in project management managing and/or coordinating domestic and/or international mid-late stage clinical research projects in the biopharmaceutical industry.

• Strong knowledge of cross functional drug development including Clinical and Regulatory

• Experienced in regulatory submissions e.g., IND, CTA, NDA

• Proficient in various Project Management tools, software, systems, etc.

• Ability to establish processes in ambiguous environment

• Good organizational skills, detail-oriented & accurate

• Advanced analytical skills

• Must be a team player

• Motivated self-starter, strategic thinker, persistent, tactful, and persuasive

• Excellent communication and interpersonal skills

• Ability to handle multiple responsibilities, priorities, tasks, and projects simultaneously

• Ability to work under time pressure and effectively in a team or matrix environment

What we offer:

Mineralys Therapeutics offers a collaborative company culture. In addition to working with a team of highly competent professionals in a growing company, benefits include:

• Professional flexibility and remote workforce

• Competitive Compensation

• Generous Health Benefits

• Paid Holidays

• Flexible Vacation Policy

• 401(k) match

• Home office stipend

How to apply:

Send your CV to careers@mineralystx.com and feel free to include a note that tells us more about you!

About Mineralys Therapeutics Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is initially developing for the treatment of patients with uncontrolled hypertension. Mineralys Therapeutics is based in Radnor, PA. Follow Mineralys on LinkedIn and Twitter.

The Role

Mineralys is seeking an Associate Director, Clinical Operations. This position is responsible for resourcing and performance management of Clinical Trial Associates, operational delivery of clinical trials and supporting the development and oversight of department goals and initiatives. A successful candidate will have program management experience, clinical operations experience, and a strong ability to function in an ambiguous and fast paced work environment.

What you will do:

• Manages Clinical Trial Associates with responsibility for recruitment, resourcing, training, performance management, employee goal setting and career development. May also manage contract staff.
• Supports execution of operational strategy (study scenario planning, operational decision points and risks, study timeline, study financials) for assigned program(s).
• Responsible for operational delivery of assigned clinical trials within program lifecycle, overseeing cross-functional alignment, budget, and timeline from protocol generation through completion of the clinical study report, ensuring quality and a focus on inspection readiness throughout.
• Proactively identifies study and program risks and implements contingency plans, providing regular updates on study status to Mineralys Leadership Team.
• Participates in vendor identification and responsible for vendor set up and oversight.
• Active involvement in investigator identification and selection, including expansion to new geographies.
• Provides oversight of the development of study documentation, including clinical trial protocols, study plans and clinical study reports.
• Participates in cross functional study data review.
• Supports development and oversight of departmental goals and objectives for Clinical Operations.
• Tracks key performance indicators and metrics for Clinical Operations and identifies opportunities to develop and optimize processes and procedures (e.g., SOPs, Work Instructions).
• Leads cross-functional initiatives.
• Contributes to building a culture of team, site and patient centricity.

What you will bring:

• Bachelor’s Degree in Life Sciences
• 12 years of experience executing clinical trials globally across all phases of development
• Minimum of 3 years’ supervisory/management experience
• Advanced project/program management skills including timeline and budget management, risk assessment and mitigation planning.
• Proven track record of successfully overseeing staff to execute and deliver clinical trials on time and on budget, ensuring inspection readiness throughout.
• Excellent understanding of GCP, CFR and ICH Guidelines.
• Effective team leadership in cross-functional study and program teams, with demonstrated strength in team building.
• Demonstrated ability to effectively interface successfully with external parties, including key personnel at investigational sites, Key Opinion Leaders, and vendors.
• Excellent verbal and written communication skills, organizational skills, problem solving and conflict resolution skills.
• Strong interpersonal skills.
• Self-motivated and proactive with ability to work independently in highly time sensitive environment.

What we offer:

Mineralys Therapeutics offers a collaborative company culture. In addition to working with a team of highly competent professionals in a growing company, benefits include:

• Professional flexibility and remote workforce
• Competitive Compensation
• Generous Health Benefits
• Paid Holidays
• Flexible Vacation Policy
• 401(k) match
• Home office stipend

How to apply:

Send your CV to careers@mineralystx.com and feel free to include a note that tells us more about you!

About Mineralys Therapeutics

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is initially developing for the treatment of patients with uncontrolled hypertension. Mineralys Therapeutics is based in Radnor, PA.

Follow Mineralys on LinkedIn and Twitter.

The Role

The Clinical Trial Associate/Sr. Clinical Trial Associate (CTA/Sr CTA) performs tasks related to operational strategy in support of study management from start-up through closeout. The CTA/Sr CTA is responsible for assisting and providing support to the members of the Clinical Operations team (Clinical Trial Managers, Clinical Research Associates, and Medical Monitors). This position requires prior experience or training in clinical research and GCP/ICH guidelines. Under general supervision, this person assists with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned.

What you will do:

• Provide support for day-to-day study activities in accordance with established protocols under the general guidance of the assigned Clinical Trial Manager
• Support the Clinical Operations team in the successful execution of assigned clinical trials from protocol concept through to clinical trial report, in compliance with international Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
• Contribute to the creation and/or review of, and distribute and track Study Reference Materials e.g., Study protocol, Study Reference Manual, Pharmacy Manual, Monitoring Plan, TMF Plan, Informed Consent Form, site and study training materials.
• Under direction of the Clinical Operations team, perform clinical trial activities for ongoing and new clinical trials (local or global) including, status report and metric generation, maintenance of: Investigational Product (IP) and regulatory document tracking systems, and files required regulatory documents, and the Trial Master Files (TMFs)
• Help manage external vendors by setting up meetings, taking minutes, proactively communicating, and responding to requests.
• Support in the review of CRFs, including participating in the EDC and RTSM
• specification process and UAT.
• Under the direction of the Clinical Trial Manager review and track Site selection/Visit reports: Qualification Visits, Initiation Visit Reports, and Interim Monitoring Visit Reports
• Coordinate IP-handling processes including initiating shipments and returns, tracking inventory at sites and assisting with IP reconciliation.
• Assist with distribution, collection and tracking of regulatory documents (e.g., confidentiality disclosures, IRB approvals, and financial disclosures) to/from study sites.
• Provide input on and distribute recruitment and other research subject facing study materials.
• Maintain study site information, track IP, ancillary product inventory, track clinical study-related documents, and subject follow-up schedule and visit status, as required
• Support in the review and tracking of invoices from vendors/consultants as per contract
• Support the planning of Investigator Meetings and/or Site and CRA trainings as required
• Manage the oversight of sample collection and analysis (e.g., lab samples, PK samples)
• Assist with preparation of reports (management reports, regulatory reports, etc.), as required.
• Assist with archiving study documents for completed clinical trials
• Demonstrates working knowledge of clinical research conduct, laws, regulations, and standards, and complies with applicable SOP’s and policies
• Contribute to building a culture of team, site, and patient centricity

What you will bring:

• Bachelor’s level degree in life sciences, pharmacy or nursing preferred
• 2 – 5+ years’ experience within the Pharmaceutical-biotech industry
• Experience in Phase 2 or Phase 3 studies and global studies is an asset
• Basic knowledge of clinical trial operations, ICH GCP Guidelines and other

applicable regulatory requirements

• Experience working in a team across multiple functional areas (e.g., work

with Quality Assurance, Data Management, Safety, Medical, Project Management

• Strong written and verbal communication skills
• Must be flexible, adaptable, proactive, and work well under pressure
• Experience collaborating successfully across multiple teams and levels

What we offer:

Mineralys Therapeutics offers a collaborative company culture. In addition to working with a team of highly competent professionals in a growing company, benefits include: 

• Professional flexibility and remote workforce
• Competitive Compensation
• Generous Health Benefits
• Paid Holidays
• Flexible Vacation Policy
• 401(k) match
• Home office stipend

How to apply:

Send your CV to careers@mineralystx.com and feel free to include a note that tells us more about you!  

About Mineralys Therapeutics
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is initially developing for the treatment of patients with uncontrolled hypertension. Mineralys Therapeutics is based in Radnor, PA. Follow Mineralys on LinkedIn and Twitter.

The Role

This role will be responsible for strategic leadership and implementation of all aspects of the clinical pharmacology program for compounds in development, including early (Phase 1) and late-stage development activities (Phase 2/3 and NDA filings). This individual will lead the characterization and prediction of the pharmacokinetics, pharmacodynamics, and drug metabolism of the drug candidate. This role will report to the Chief Medical Officer.

What you will do:

• Evaluate and revise clinical pharmacology strategy to ensure successful global regulatory submissions and registration
• Manage entire clinical pharmacology program: strategy, vendor selection, study design, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans
• Provide strategic clinical pharmacology input to cross functional clinical development teams
• Determine scope, design, and planning and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations (e.g., Simcyp) focusing on necessary components to support an NDA submission
• Author clinical pharmacology regulatory documents (IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquires
• Lead and prepare appropriate documents or sections of clinical protocols, clinical study reports with respect to clinical pharmacology data
• Select and manage clin pharm CROs and other external vendors to ensure compliance with agreed protocols, quality standards and timelines
• Manage bioanalysis and PK activities at CROs and other external vendors
• Lead corporate biomarker strategy development and execution across clinical development (preferred)

What you will bring:

• PhD, PharmD or equivalent training in Clinical Pharmacology, Pharmacokinetics, or a related field with 10+ years of biotech or pharmaceutical industry experience as a clinical pharmacologist with proven understanding of drug development
• Strong knowledge of pharmacokinetics and pharmacodynamics principles, modelling and simulation (e.g. Simcyp), Model-Informed Drug Development, ADME Concepts, and latest regulatory clinical pharmacology requirements to support clinical development and regulatory submissions including NDA
• Proven regulatory submission authorship experience (recent NDA submission development preferred)
• Proficiency and experience in common PK / PD modeling software packages (i.e., Phoenix WinNonlin, NONMEM, R, SAS, and other similar tools)
• Experience in biomarker development, analysis and data interpretation with an ability to integrate scientific and disease specific contexts (preferred)
• Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
• Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment

What we offer:

Mineralys Therapeutics offers a collaborative company culture. In addition to working with a team of highly competent professionals in a growing company, benefits include: 

• Professional flexibility and remote workforce
• Competitive Compensation
• Generous Health Benefits
• Paid Holidays
• Flexible Vacation Policy
• 401(k) match
• Home office stipend

How to apply:

Send your CV to careers@mineralystx.com and feel free to include a note that tells us more about you!  

About Mineralys Therapeutics
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is initially developing for the treatment of patients with uncontrolled hypertension. Mineralys Therapeutics is based in Radnor, PA. Follow Mineralys on LinkedIn and Twitter.

The Role

This position is responsible for administrative support to the Clinical Development Team in our dynamic, early-stage biopharmaceutical company. It is a high-paced environment and therefore the day-to-day responsibilities require strong collaboration across a wide range of business partners both inside and outside of Mineralys. The ideal candidate must be seasoned and experienced in handling a wide range of administrative related tasks and be able to work independently and confidently under pressure. Building strong relationships, being resourceful and knowing how to navigate your efforts to maximize the team’s impact is a must.

What you will do:

• Support senior leaders including Chief Medical Officer and SVP, Clinical Operations
• Proactively manage and maintain schedules, including calendar management, meeting scheduling and agenda development and travel arrangements.

• Prepare and edit correspondence, reports, word documents, excel spreadsheets and PowerPoint presentations

• Assist with the preparation of scientific reports, presentations, and other materials as needed.
• Assist with initial training and onboarding new team members to the Clinical Development Team
• Possesses ability to take on responsibilities that need to be developed and managed for a successful clinical study environment.

What you will bring:

• 5 years of experience in an administrative support role, preferably in a biopharmaceutical or life science focused industry
• Strong written and verbal communication skills and ability to work in a multi-disciplinary team environment
• Strong organizational skills
• Ability to multitask with ease and prioritize work
• Excellent written and verbal communication skills
• Attention to detail and accuracy
• Strong computer skills, especially Microsoft Office applications
• Manage confidential information with discretion and professionalism

What we offer:

Mineralys Therapeutics offers a collaborative company culture. In addition to working with a team of highly competent professionals in a growing company, benefits include: 

• Professional flexibility and remote workforce
• Competitive Compensation
• Generous Health Benefits
• Paid Holidays
• Flexible Vacation Policy
• 401(k) match
• Home office stipend

 How to apply:

Send your CV to careers@mineralystx.com and feel free to include a note that tells us more about you!  

About Mineralys Therapeutics
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is initially developing for the treatment of patients with uncontrolled hypertension. Mineralys Therapeutics is based in Radnor, PA. Follow Mineralys on LinkedIn and Twitter.

The Role

The Clinical Trial Manager/Sr. Clinical Trial Manager (CTM/Sr. CTM) is responsible for oversight of operational aspects of a clinical trial from study planning through study execution and close out.

What you will do:

• The CTM/Sr. CTM leads the Trial Team (internal and external stakeholders) and partners with internal stakeholders, CROs and vendors to deliver clinical trials according to the study plan and to the highest quality standards.
• Provides Clinical Operations expertise and leadership in the management of Contract Research Organizations (CROs) and other specialized vendors to ensure successful clinical trial implementation and execution.
• Provides operational management and oversight for the successful management of clinical trials through internal clinical trial teams and through the use of CROs and internal resources.
• Conducts project risk analysis and develops risk mitigation strategies for a variety of complex problems in order to maintain study deliverables.
• Plays a role in ensuring that the Trial Team effectively interfaces with key functional groups.
• Contributes to the development and presentation of clinical trial operational updates to senior/executive leadership.
• Oversees, manages, and ensures clinical trials are executed according to key performance indicators (timelines, budget, operational and quality standards).
• Maintains procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems.
• Manage clinical trial budgets, providing ongoing financial reporting and projections to Finance.
• Contributes and/or authors the creation and finalization of key trial documentation: Protocols, Informed consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc.
• Liaise with clinical site staff and Investigators to ensure optimal sponsor-site relationships
• Leads Clinical Operations inspection readiness activities.
• Develops and ensures execution of activities outlined in various study plans (data management, risk management, safety management, and study communication plans).
• Partners with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials.
• Plans and forecasts Investigational Product (IP) needs in conjunction with CMC/clinical supplies.
• Proactively manages the internal teams and CRO in all aspects of study progress from planning to close-out to assure adherence to intended timelines, budgets and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.

What you will bring:

• Bachelor’s level degree in life sciences, pharmacy or nursing preferred
• Minimum of 5 – 10 + years of Clinical Operations experience in Biopharmaceutical development with experience moving product candidates from Phase I through pivotal studies or equivalent Global clinical trial management experience (all phases of development)
• Communication Proficiency
• Problem Solving/Analysis
• Project Management
• Strategic Thinking
• Title is considered based on all qualifications and number of years of experience.

What we offer:

Mineralys Therapeutics offers a collaborative company culture. In addition to working with a team of highly competent professionals in a growing company, benefits include: 

• Professional flexibility and remote workforce
• Competitive Compensation
• Generous Health Benefits
• Paid Holidays
• Flexible Vacation Policy
• 401(k) match
• Home office stipend

How to apply:

Send your CV to careers@mineralystx.com and feel free to include a note that tells us more about you!  

 About Mineralys Therapeutics
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is initially developing for the treatment of patients with uncontrolled hypertension. Mineralys Therapeutics is based in Radnor, PA. Follow Mineralys on LinkedIn and Twitter.