South San Francisco, CA, USA
Senior Clinical Trial Leade r (Sr. CTL)
SUMMARY: The Senior Clinical Trial Leader ( Sr.CTL ) a cts as a senior clinical trial lead on one or more clinical studies. He/She d evelops, manages and coordinates all clinical trial activities for their studies including managing Clinical Research Organizations ( CROs ) , vendors and internal team members. The Sr CTL d evelops and applies best practices in the development, initiation, planning, execution, control and closing of projects. He/She is a proficient communicator and effective influencer who builds and maintains strong relationships internally and externally. All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures.
ESSENT IAL DUTIES AND RESPONSIBILITIES:
Lead more than one or highly complex, adaptive or pivotal studies
Plan and execute studies from feasibility to close out, accountable for all study budgets, documents , drug supply, and plans with 3- year horizon
Select countries and sites based on Clinical Development Plans and global Strategies
Conduct program level feasibility and develop recruitment plans
Actively lead cross functional team and attend Clinical Sub Team/Project Team meetings as needed to represent Clinical Operations
Create and maintain performance and quality metrics
Contribute clinical information for Regulatory submissions and responses
Proactively identify risks and devise mitigation plans
Expert in complex vendors and relationships
Select CRO, other vendors, manages Scope of Work ( SOW ) , scope changes, budgets, approve all vendor payments . Ensure that CRO has strategic direction for protocol(s)
Hold vendors accountable to Scope of Work ( SOW )
Responsible for contributing to and delivering study and therapeutic area training for team and vendors
Accountable for I nvestigator M eeting s, oversee planning
Accountable for ensuring data quality and timely data reviews conducted
May attend qualification or Site Initiation Visit
Develops and drives site engagement strategy
Highly skilled communicator, builds & maintains strong relationships internally and externally
Drive protocol & amend ments Investigator Brochure, Informed Consent Form , monitor plans, risk management
Reviews clinical sections of other regulatory documents e.g. annual or periodic safety reports, IND/NDA filings for quality and consistency
Build compelling, data driven case, clearly articulates vision to business partners, CROs, etc
Provides supervision, coaching and mentoring to new study leaders, CTMs and Associates
Responsible for growth, development, and promotion of full time direct reports using development planning tools . Contribute to hiring of new staff.
Master of Clinical operations, can lead any study and is a protocol expert
Understand and apply knowledge of science/biology, e.g. cardiology, mechanism of action of drug to planning and all phases of the study
Seek to stay current with new advances, competition
Accountable for complete Trial Master File and training of study team, internal and external business partners
Supervisory r equirements
Directly supervises 1-3 employees
May be responsible for external consultants
BS/BA required .
MS/MA degree in related discipline desired .
Typically requires a minimum of 8 years of related experience and/or combination of experience and education/training research in the biotechnology/pharmaceutical industry.
Experience in the operational aspects of managing phase 1-3 clinical studies from start-up to closeout, vendor management, and planning cross-functional operational activities .
Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management .
Thorough clinical research knowledge and cross-functional understanding of clinical trial methodology is required.
Knowledge of ICH-GCPs and 21 CFR is required .
May lead or oversee the work of others by providing direction and by using established policies and precedents.
General project management skills with the ability to organize, prioritize and manage numerous tasks and complete them under time constraints.
Ability to apply strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques.
Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.
Ability to travel up to 25%
Performs job duties with minimal guidance from supervisor .
Works on problems of complex scope where analysis of data requires evaluation of identifiable factors.
Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Creates formal networks involving coordination among groups.
Passion for science
Imagine and innovate
South San Francisco, CA, USA
The Manager of SEC Reporting and Technical Accounting is responsible for all SEC financial reporting activities and technical accounting analysis. This individual will frequently interact with accounting staff, IT, legal, and other stakeholders across the organization as well as external SOX consultants and external auditors. This role requires critical thinking skills, effective organizational skills, excellent written and verbal communication skills, and a strong ability to build effective relationships across the Company. This position offers the successful applicant the opportunity to leverage a strong background in external reporting, technical accounting and Sarbanes-Oxley compliance with the dynamics of a growing biotechnology company.
Lead the timely and accurate preparation of Company’s SEC filings, including 10-Qs and 10-Ks, ensuring appropriate XBRL tagging of related content in Active Disclosure.
Gather supporting data, tie outs and preparing information for review.
Create and maintain SEC calendar, coordinate key timelines as well as deliverables and inform parties of necessary deadline adherence for the following processes: financial close, BOD package, press release and 10-Q/K
Ensure financial statements are presented in accordance with GAAP guidelines.
Proactively identify accounting & disclosure issues and perform related research and documentation of such issues in accounting whitepapers; propose suitable disclosures and benchmark against industry standards.
Maintain relationship and work closely with External Auditors, Business Owners and Senior Management to ensure communication of critical issues in a timely manner.
Coordinate/monitor/review the execution of audit procedures related to financial reporting and technical accounting topics.
Partner with SOX consultants in documentation of SOX Risk Assessment, Risk Matrix, Process Documents, Testing Protocol, and Review Testing for financial reporting and other related cycles.
Support the assessment of internal controls over financial reporting in according with the COSO Framework and Sarbanes-Oxley Act (SOX).
Stay abreast of new accounting principles, SEC reporting and general trends.
Participate in special projects and perform additional duties as required.
Education and Professional Qualifications:
Deep subject matter expertise in SEC reporting, technical accounting and US GAAP accounting standards
CPA required, with a Masters in Accounting or MBA preferred
Minimum of 6 years of relevant work experience to include 4 years for a Big 4 public accounting firm, followed by experience in SEC reporting for a publicly held, 404(b) compliant, large accelerated filer.
Experience in preparing SEC financial filings for a public company, including use of an SEC filing platform, such as Active Disclosure
Exceptional leadership and teamwork capabilities
Excellent oral and written communications skills
Strong personal drive for excellence and highly self-motivated with strong work ethics
Well-developed problem-solving skills combined with experience working with outside consultants in a positive and collaborative manner.
Enjoys being ‘hands-on’ and taking ownership of processes
Able to work in an environment where sharing responsibility for success and mitigating the shortcomings of others on the team is critical to the overall success of the Company.
Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.
Possesses a sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
Role model for MyoKardia’s values.
South San Francisco, CA, USA
Summary: This person reports to the Director of Technical Operations and Clinical Supply Chain. This role will allow the ideal person to be exposed to new methodologies.
These may include, but are not limited to, the following; other duties may be assigned:
Develop clinical study supply plans and maintain active inventory tracking for both clinical and placebo investigational drug products in compliance with company’s internal procedures and GxP requirements. Have experience and knowledge of executing Phase I – III protocols.
Prepare clinical trial material forecasts at the study level and track material inventory, update use and expiry dating to ensure uninterrupted delivery of clinical study supplies. Proactively highlights to management when action is indicated. “Actions” may include a shelf life extension or resupply submission to health authorities are necessary.
Have experience and thorough understanding of IXRS/IRT systems and trial execution using these systems.
Participate in global clinical drug supply activities associated with the team’s trials (secondary packaging vendor selection, technical batch record review, QP Release coordination, clinical label design, packaging and labeling, IRT efficiencies)
Vendor Management – Prioritize labelling and packaging activities at CROs/CMOs, when packaging operations for clinical trial material are in-process.
Establish the packaging design based on protocol and manage all packaging activities including work order creation, review and approval of contractor packaging records and monitoring work at contractors
Ability to coordinate CTM shipping and logistics activities including management of shipments of CTM from between storage/distribution sites and to clinical trial sites
Ability to coordinate courier deliveries and shipments, and manage the courier relationship. Oversee packaging of materials according to IATA or DOT dangerous goods regulations. Oversee special projects including international shipments with awareness of required US Government certificate / license, if applicable, for worldwide shipment of investigational clinical trial material, drug substance, and drug product.
Review temperature logs for CTM distribution and storage and investigates temperature deviations according to SOP
Actively communicates supply plan progress to all stakeholders. Builds and maintains positive working relationships with co-workers and functional areas to accomplish project objectives.
Participates on clinical sub-teams and provides clinical supply updates and summaries to management. Supports management with implementation of departmental strategies and policies.
BS or Master’s Degree in life science, or related field (or equivalent experience)
8-10 years’ experience in GMP clinical supply chain, supply chain or pharmaceutical program management at a CRO and/or pharmaceutical/biotech organization.
Preferably Certificate in Supply Chain Management Program
Ability to work independently to make strategic decisions related to planning, and budgeting.
Understanding of cGMP’s and pharmaceutical industry procedures and regulations
Must have Clinical Supplies Packaging experience, distribution experience, supply chain and project management experience
Hand on experience with Interactive Web Response System (IVRS/IWRS) clinical supply software
Strong, open and transparent communication skills (verbal and written)
Solid organizational and time management skills
Project management skills and computer proficiency
Experience with: MS Excel, Word
Ability and willingness to travel 10% of the time (internationally and domestically)
South San Francisco, CA, USA
Develop a comprehensive understanding of the market environment, including market penetration, market potential, and future trends
Manage primary & secondary market research studies, including project objectives & design, vendor selection & oversight, monitoring of data collection & analysis, and interpretation, across multiple customer groups
Integrate key market dynamics and cross-functional expertise into revenue forecasts
Build, refine, pressure-test, and present revenue forecasts that support decision-making processes for key cross-functional partners
Develop relevant and compelling presentations of market research insights, revenue forecasts, and recommendations that drive key strategic and tactical decisions for cross-functional partners
Manage ongoing business relationships with vendors, consultants and selected partners; manage complex projects within budget and timeline
Knowledge & Skills
Experience designing and conducting quantitative and qualitative market research across multiple customer groups, including but not limited to physicians, patients, allied health care professionals, pharmacists, and advocacy groups
Experience in building & maintaining forecast models as well as a firm grasp of complex forecasting & modeling techniques that support various types of strategic analytics; experience in generating commercial insights from pharmaceutical datasets
Strategic thinker who understands the critical role of market research & forecasting in developing commercial strategy in support of a product launch; ability to operate in ambiguous situations and determine focused objectives and a clear path forward in the face of open questions
Balance of exceptional technical expertise with strong strategic thinking and practical business orientation; strength in finding and focusing on key business drivers
Ability to analyze complex issues, distill information to essential knowledge, develop business-relevant strategic recommendations, and persuasively present to a range of stakeholders
Highly developed interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of backgrounds
Ability to multiple manage projects and timelines for both internal initiatives and with external vendors
Must have a proven ability to sustain a high energy level over time
Education & Experience
BA, BS required. Master’s degree in business or science preferred
3 to 7 years of market research/forecasting experience in the bio/pharmaceutical industry
Launch experience is preferred
Previous consulting & recent bio/pharma experience is preferred
South San Francisco, CA, USA
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Prepare isolated adult animal cardiomyocytes for contractility assays
Use pre-established experimental designs to plan, and execute myocyte contractility and Ca2+ transient assays
Be responsible for data collection, organization and record keeping
Identify, communicate and triage assay anomalies during data collection or analysis of experimental results
Propose solutions to technical issues: proactively seek out senior team member to discuss potential resolutions to problems
Collaborate with colleagues and team members to provide robust data
Understand and follow IACUC approved protocols for animal use
Flexibility to start (and leave) work early 2-3 times/week to initiate protracted experiments (~7:00 AM)
Requires a BS in physiology, pharmacology, or related discipline.
Minimum of 1-2 years of animal handling experience in a pharmaceutical industry or academic research lab setting
Experience in pharmaceutical science, preferably in pharmaceutical industry focusing on cardiovascular science.
Familiarity with cellular electrophysiology advantageous, but non-essential
Hands-on experience with animal handling (mice and rats), and tissue collection, particularly heart.
Ex vivo adult rat cardiac myocyte isolation and myocyte contractility experience a plus