Director of Clinical Operations
SYMIC Overview:
Symic Bio is a clinical stage biotherapeutics company focused on matrix biology. Symic is developing a platform of matrix regulators, novel compounds that target and regulate the extracellular matrix (ECM), the noncellular component of tissue. The ECM plays a critical role in a wide variety of processes involved in acute and chronic indications. The matrix regulators generated by Symic Bio's proprietary technology are inspired by proteoglycans, which are naturally occurring macromolecules that play important structural and regulatory functions in the ECM. Symic Bio currently has a unique molecule being evaluated for vascular injury in Phase II clinical studies. Additionally, Symic Bio's pipeline includes preclinical programs targeting oncology, fibrosis and CNS disorders.
JOB
Summary:
The Director of Clinical Operations oversees the Clinical Operations function responsible for the strategy, planning, and successful execution of clinical programs in the company. This individual ensures that all clinical operation activities are executed in the most cost and time effective way, while assuring quality and GCP compliance. Accountable for timelines and budget, including best practice vendor and consultant management in achieving deliverables, the Director of Clinical Operations operates effectively to lead individual clinical programs, and works with the management team to progress the entire company portfolio.
PRIMARY
Responsibilities:
Direct all aspects of timeline/fiscal management, analyses, compliance, and conduct global and domestic clinical trials to ensure delivery of company goals on time, within budget and in compliance with SOPs, FDA and ICH/GCP guidelines.
Anticipate and develop strategic planning activities and ensure translation of strategic decisions into operational plans.
Together with the CMO, oversee proposals, selection and management of CROs and other vendors for the conduct and management of clinical trials.
Partner collaboratively with key internal functions such as Medical, Regulatory, CMC, and Program Management to implement the Company's clinical strategies and drive organizational success.
Manage clinical operations group with direct reports who may include both internal staff and consultants. Ensure optimal workforce planning, retention, coaching, and performance management of the staff. Mentor and manage the development of direct reports.
Maintain collaborative relationships with vendors, key opinion leaders, investigators, and other key individuals as necessary to ensure appropriate program progress and overall business and clinical objectives.
Represent clinical operations plans and status to partners and senior audiences.
Effectively partner with Human Resources to conduct workforce planning for implementation of company operational plans and develop a resource-tracking process.
Partner with Finance to develop and manage the Clinical Operations budget and update Senior Management with progress and anticipated changes in scope, schedule and resources in a timely manner.
Optimize and implement SOPs, processes, communication, & infrastructure within Clinical Operations Department to support company goals including Regulatory filings.7
years of experience in leading clinical operations teams responsible for successful execution of clinical programs in a pharmaceutical or a biotechnology company. Experience with osteoarthritis or vascular disease clinical trials is a plus.
Bachelor's degree in science or related field, advanced (clinical) degree preferred.
Experience with all operational aspects of a clinical trial program leading to a NDA/BLA.
Demonstrated ability to select CROs, set up trials, enroll sites, maximize recruitment, and maintain high quality standards that significantly exceed industry standards.
DESIRED COMPETENCIES
Ability to demonstrate effective leadership in frequently changing situations.
Outstanding written and verbal communication skills including presentation effectiveness.
Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Willingness and ability to travel domestically and internationally as required up to 20%.
Location: Symic is located in Emeryville, CA
Compensation: Competitive salary and equity as one of the early hires for the companyEstimated Salary: $20 to $28 per hour based on qualifications.
Symic Bio is a clinical stage biotherapeutics company focused on matrix biology. Symic is developing a platform of matrix regulators, novel compounds that target and regulate the extracellular matrix (ECM), the noncellular component of tissue. The ECM plays a critical role in a wide variety of processes involved in acute and chronic indications. The matrix regulators generated by Symic Bio's proprietary technology are inspired by proteoglycans, which are naturally occurring macromolecules that play important structural and regulatory functions in the ECM. Symic Bio currently has a unique molecule being evaluated for vascular injury in Phase II clinical studies. Additionally, Symic Bio's pipeline includes preclinical programs targeting oncology, fibrosis and CNS disorders.
JOB
Summary:
The Director of Clinical Operations oversees the Clinical Operations function responsible for the strategy, planning, and successful execution of clinical programs in the company. This individual ensures that all clinical operation activities are executed in the most cost and time effective way, while assuring quality and GCP compliance. Accountable for timelines and budget, including best practice vendor and consultant management in achieving deliverables, the Director of Clinical Operations operates effectively to lead individual clinical programs, and works with the management team to progress the entire company portfolio.
PRIMARY
Responsibilities:
Direct all aspects of timeline/fiscal management, analyses, compliance, and conduct global and domestic clinical trials to ensure delivery of company goals on time, within budget and in compliance with SOPs, FDA and ICH/GCP guidelines.
Anticipate and develop strategic planning activities and ensure translation of strategic decisions into operational plans.
Together with the CMO, oversee proposals, selection and management of CROs and other vendors for the conduct and management of clinical trials.
Partner collaboratively with key internal functions such as Medical, Regulatory, CMC, and Program Management to implement the Company's clinical strategies and drive organizational success.
Manage clinical operations group with direct reports who may include both internal staff and consultants. Ensure optimal workforce planning, retention, coaching, and performance management of the staff. Mentor and manage the development of direct reports.
Maintain collaborative relationships with vendors, key opinion leaders, investigators, and other key individuals as necessary to ensure appropriate program progress and overall business and clinical objectives.
Represent clinical operations plans and status to partners and senior audiences.
Effectively partner with Human Resources to conduct workforce planning for implementation of company operational plans and develop a resource-tracking process.
Partner with Finance to develop and manage the Clinical Operations budget and update Senior Management with progress and anticipated changes in scope, schedule and resources in a timely manner.
Optimize and implement SOPs, processes, communication, & infrastructure within Clinical Operations Department to support company goals including Regulatory filings.7
years of experience in leading clinical operations teams responsible for successful execution of clinical programs in a pharmaceutical or a biotechnology company. Experience with osteoarthritis or vascular disease clinical trials is a plus.
Bachelor's degree in science or related field, advanced (clinical) degree preferred.
Experience with all operational aspects of a clinical trial program leading to a NDA/BLA.
Demonstrated ability to select CROs, set up trials, enroll sites, maximize recruitment, and maintain high quality standards that significantly exceed industry standards.
DESIRED COMPETENCIES
Ability to demonstrate effective leadership in frequently changing situations.
Outstanding written and verbal communication skills including presentation effectiveness.
Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Willingness and ability to travel domestically and internationally as required up to 20%.
Location: Symic is located in Emeryville, CA
Compensation: Competitive salary and equity as one of the early hires for the companyEstimated Salary: $20 to $28 per hour based on qualifications.
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