Director, Clinical Development
OverviewCook MyoSite, Inc.
is on a mission to make regenerative medicine a part of everyday medicine.
Were investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders.
We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours.
Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose.
If youre curious, motivated by helping others, and driven by integrity, we invite you to apply.
The Director Leadership team is tasked with developing and communicating the overall strategic vision to the organization and leading the motivational drive to achieve this.
Director Leadership is subordinate to the Vice Presidents in the hierarchical organization.
They are accountable for making decisions and ensuring the successful completion of strategic initiatives are aligned with quality, operational, and best business practices.
Director Leadership functions revolve around overseeing direct reports, creating and executing short-term and long-term staff development plans, and developing, reviewing, and enforcing company policies.
Responsibilities Direct, manage and provide support to all global clinical activities associated with company therapeutic regenerative medicine and associated programs.
Provide direct oversight of Clinical Affairs, Clinical Science, and Clinical Safety departmental activities and provide executive authority and responsibility over these departments.
Devises the strategy and ensures the execution of clinical development activities to align with regulatory and business pathways in support of company clinical program objectives.
Key stakeholder in the preparation, completeness, accuracy, and maintenance of clinical regulatory submissions, reporting and associated documents.
Ensures all clinical development activities are conducted in compliance with applicable regulations through both quality system and business operating procedure development.
Interfaces directly with health authorities and personnel, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications.
Plans and conducts formal meetings and teleconferences with health authorities and other key clinical stakeholders.
Provides interpretive analyses of complex regulatory guidance documents, regulation, or directives that impact clinical products and operations.
Stakeholder in patient advocacy initiatives and seeks to ensure that patient perspectives are incorporated into relevant communications and development activities.
Leads and oversees the effective use of internal and external communication (e.
g.
presentations, publications) of clinical development activities.
Works with executive management to ensure consistency and alignment of company activities with clinical program objectives and activities.
Blends subject matter knowledge from the clinical sciences, operations, regulation, law, and business to direct company clinical development programs.
Ensures the effective and efficient use of company resources to achieve development objectives.
Ensures directorate/department is managing and meeting annual budget.
Responsible for the planning and the timely submission of directorate/department budget requests and considerations to the Vice President(s) and finance department in accordance with the annual budgeting timeline.
Responsible for short and longer-term company impacting decisions and output.
Effectively delegates and follows up on completion of work.
Regularly and consistently provides status reports on all active projects and initiatives to Vice President(s.
) Develops, reviews, and enforces company policies.
Ability to present highly complex information to a broad audience in a clear and comprehensive manner.
Is an effective communicator with internal and external stakeholders.
Conveys clear expectations, actively listens to input and responds to feedback appropriately and in a timely manner.
Is action orientated and follows up on feedback to ensure positive outcomes.
Accountable for successful organizational outcomes and holds teams accountable for all stated responsibilities.
Is a critical thinker with proven problem-solving and decision-making abilities.
Ensures company maintains focus on our customers.
Exhibits well-developed prioritization, planning, organization and time management skills.
Acts as management with executive responsibility.
Oversees direct reports:
Creates and executes short and long-term staff development plans.
Conducts performance reviews that hold direct reports accountable to essential job functions and departmental standards of position.
Ensures that directorate status meetings are held on regular basis and conducts monthly one on one meetings with direct reports.
Directly responsible for directorate staff resource planning.
Responsible for departmental hiring decisions and participates in recruitment of staff.
Makes decisions and ensures the successful completion of strategic initiatives that are aligned with quality, operational and business best practices.
Develops and communicates the overall strategic vision for the organizationQualifications Master's degree in Life Sciences or undergraduate degree in Life Sciences plus 5 years of direct, relevant clinical development experience Minimum of 15 years' experience in Biotechnology or Pharmaceutical clinical development Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook Advanced understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing Communicates and exemplifies Cook MyoSite core values.
Demonstrates strong interpersonal skills resulting in exceptional rapport with people.
Proven success initiating, promoting and maintaining strong interpersonal relations Is a teacher and trusted leader.
Demonstrates decisiveness by making decisions in a timely manner.
Identifies and effectively manages conflict.
Proactively and appropriately challenges the status quo and champions change for the advancement of the organization.
Is a positive influence within the company and supports it, and their colleagues, both publicly and privately.
Builds a strong team and supports its progress with compassion and enthusiasm.
Demonstrates passion for our mission even through times of challenge and adversity.
Understands and embraces the vision and inspires others to realize it.
Is decisive and able to employ the appropriate balance of risk taking and judiciousness.
Promotes a healthy culture aligned with MyoSite's values.
Preferred
Qualifications:
PhD in Life Sciences and minimum of 10 years clinical development experience with exposure to Biologics cGMP environment.
Knowledge of FDA and foreign regulatory requirements as well as industry quality management tools, trends, practices, standards, and Biologics quality system.
Physical Requirements:
Full Time Remote Remote / Field Based:
General office or home office setting.
Ability to conduct and hear ordinary conversation and telephone communication.
Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
Ability to work under specific time constraints.
Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
Visual and manual acuity for working with computers and equipment.
Employee that interacts with Healthcare Professional:
In addition to below, Compliance with Cook Policy & Guidance On Interaction with Healthcare Professionals.
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.
At Cook MyoSite, we dont just accept difference we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community.
Cook MyoSite is proud to be an equal opportunity workplace.
This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities.
This may be subject to change at any time due to reasonable accommodation or other reasons.
Requisition ID2023-12776Posting Date2 weeks ago(7/21/2023 10:
23 AM)Job Location(s) Pittsburgh PA United States Travel 10-20% Position Type Full Time Company Cook Myosite Inc.
Category Clinical Recommended Skills Administration Adobe Biopharmaceuticals Biotechnology Clinical Works Curiosity Estimated Salary: $20 to $28 per hour based on qualifications.
is on a mission to make regenerative medicine a part of everyday medicine.
Were investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders.
We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours.
Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose.
If youre curious, motivated by helping others, and driven by integrity, we invite you to apply.
The Director Leadership team is tasked with developing and communicating the overall strategic vision to the organization and leading the motivational drive to achieve this.
Director Leadership is subordinate to the Vice Presidents in the hierarchical organization.
They are accountable for making decisions and ensuring the successful completion of strategic initiatives are aligned with quality, operational, and best business practices.
Director Leadership functions revolve around overseeing direct reports, creating and executing short-term and long-term staff development plans, and developing, reviewing, and enforcing company policies.
Responsibilities Direct, manage and provide support to all global clinical activities associated with company therapeutic regenerative medicine and associated programs.
Provide direct oversight of Clinical Affairs, Clinical Science, and Clinical Safety departmental activities and provide executive authority and responsibility over these departments.
Devises the strategy and ensures the execution of clinical development activities to align with regulatory and business pathways in support of company clinical program objectives.
Key stakeholder in the preparation, completeness, accuracy, and maintenance of clinical regulatory submissions, reporting and associated documents.
Ensures all clinical development activities are conducted in compliance with applicable regulations through both quality system and business operating procedure development.
Interfaces directly with health authorities and personnel, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications.
Plans and conducts formal meetings and teleconferences with health authorities and other key clinical stakeholders.
Provides interpretive analyses of complex regulatory guidance documents, regulation, or directives that impact clinical products and operations.
Stakeholder in patient advocacy initiatives and seeks to ensure that patient perspectives are incorporated into relevant communications and development activities.
Leads and oversees the effective use of internal and external communication (e.
g.
presentations, publications) of clinical development activities.
Works with executive management to ensure consistency and alignment of company activities with clinical program objectives and activities.
Blends subject matter knowledge from the clinical sciences, operations, regulation, law, and business to direct company clinical development programs.
Ensures the effective and efficient use of company resources to achieve development objectives.
Ensures directorate/department is managing and meeting annual budget.
Responsible for the planning and the timely submission of directorate/department budget requests and considerations to the Vice President(s) and finance department in accordance with the annual budgeting timeline.
Responsible for short and longer-term company impacting decisions and output.
Effectively delegates and follows up on completion of work.
Regularly and consistently provides status reports on all active projects and initiatives to Vice President(s.
) Develops, reviews, and enforces company policies.
Ability to present highly complex information to a broad audience in a clear and comprehensive manner.
Is an effective communicator with internal and external stakeholders.
Conveys clear expectations, actively listens to input and responds to feedback appropriately and in a timely manner.
Is action orientated and follows up on feedback to ensure positive outcomes.
Accountable for successful organizational outcomes and holds teams accountable for all stated responsibilities.
Is a critical thinker with proven problem-solving and decision-making abilities.
Ensures company maintains focus on our customers.
Exhibits well-developed prioritization, planning, organization and time management skills.
Acts as management with executive responsibility.
Oversees direct reports:
Creates and executes short and long-term staff development plans.
Conducts performance reviews that hold direct reports accountable to essential job functions and departmental standards of position.
Ensures that directorate status meetings are held on regular basis and conducts monthly one on one meetings with direct reports.
Directly responsible for directorate staff resource planning.
Responsible for departmental hiring decisions and participates in recruitment of staff.
Makes decisions and ensures the successful completion of strategic initiatives that are aligned with quality, operational and business best practices.
Develops and communicates the overall strategic vision for the organizationQualifications Master's degree in Life Sciences or undergraduate degree in Life Sciences plus 5 years of direct, relevant clinical development experience Minimum of 15 years' experience in Biotechnology or Pharmaceutical clinical development Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook Advanced understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing Communicates and exemplifies Cook MyoSite core values.
Demonstrates strong interpersonal skills resulting in exceptional rapport with people.
Proven success initiating, promoting and maintaining strong interpersonal relations Is a teacher and trusted leader.
Demonstrates decisiveness by making decisions in a timely manner.
Identifies and effectively manages conflict.
Proactively and appropriately challenges the status quo and champions change for the advancement of the organization.
Is a positive influence within the company and supports it, and their colleagues, both publicly and privately.
Builds a strong team and supports its progress with compassion and enthusiasm.
Demonstrates passion for our mission even through times of challenge and adversity.
Understands and embraces the vision and inspires others to realize it.
Is decisive and able to employ the appropriate balance of risk taking and judiciousness.
Promotes a healthy culture aligned with MyoSite's values.
Preferred
Qualifications:
PhD in Life Sciences and minimum of 10 years clinical development experience with exposure to Biologics cGMP environment.
Knowledge of FDA and foreign regulatory requirements as well as industry quality management tools, trends, practices, standards, and Biologics quality system.
Physical Requirements:
Full Time Remote Remote / Field Based:
General office or home office setting.
Ability to conduct and hear ordinary conversation and telephone communication.
Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
Ability to work under specific time constraints.
Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
Visual and manual acuity for working with computers and equipment.
Employee that interacts with Healthcare Professional:
In addition to below, Compliance with Cook Policy & Guidance On Interaction with Healthcare Professionals.
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.
At Cook MyoSite, we dont just accept difference we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community.
Cook MyoSite is proud to be an equal opportunity workplace.
This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities.
This may be subject to change at any time due to reasonable accommodation or other reasons.
Requisition ID2023-12776Posting Date2 weeks ago(7/21/2023 10:
23 AM)Job Location(s) Pittsburgh PA United States Travel 10-20% Position Type Full Time Company Cook Myosite Inc.
Category Clinical Recommended Skills Administration Adobe Biopharmaceuticals Biotechnology Clinical Works Curiosity Estimated Salary: $20 to $28 per hour based on qualifications.
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