Internship Director Clinical Operations Jobs (NOW HIRING)

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Job Description Summary

Job Description

The Senior Director, Clinical Operations, is a key member of the Executive Leadership Teamresponsible for the strategic and operational leadership of the Company's clinical developmentoperations. The Senior Director, Clinical Operations provides oversight of Clinical DevelopmentOperations, Nonclinical Development, Regulatory Affairs, Quality Assurance,Manufacturing/CMC Operations, and Program Management, while partnering closely withR&D, Finance, Investor Relations, Legal, and the CEO to ensure efficient execution of corporateobjectives. This role is accountable for translating the clinical operations strategy into operational execution,driving cross-functional alignment, ensuring compliance with global regulatory requirements,maintaining operational excellence, and supporting the advancement of the Company'sdevelopment pipeline from research through commercialization.
The ideal candidate will possess biotech or pharmaceutical industry background, demonstratedleadership across multiple clinical operations disciplines, and some experience in building andscaling clinical operations organizations in a fast-paced, dynamic environment.

KEY RESPONSIBILITIES:
Corporate Leadership & Strategic Operations
Serve as a member of the Executive Leadership Team and participate in corporate strategydevelopment.
Lead day-to-day company clinical operations to ensure implementation and execution ofstrategic, development, and commercial objectives.
Drive clinical operations organizational effectiveness, cross-functional communication, andexecution accountability.
Develop clinical operational plans to support corporate growth, financing activities,partnerships, and strategic initiatives.
Identify clinical operational risks and implement mitigation strategies.

Clinical Development Operations
In charge of executive oversight of clinical operations activities across all developmentprograms.
In charge of efficient execution of clinical trials, including site activation, enrollment,monitoring, data management, safety reporting, and vendor oversight. The main focus is onthe Phase 2a timely execution and progress according to established timelines.
Partner with Medical Development leadership to ensure achievement of program milestonesand timelines.
Ensure adherence to GCP and applicable regulatory requirements.
Nonclinical Development
Oversee non-clinical development vendors, consultants, activities, including pharmacology,toxicology, bioanalytical projects.
Ensure nonclinical studies are executed in accordance with GLP requirements anddevelopment objectives.
Coordinate nonclinical strategy with clinical, regulatory, and CMC functions to supportdevelopment objectives.

Regulatory Affairs
Provide strategic oversight for regulatory planning and execution.
Supervise Regulatory Affairs leadership to support INDs, meeting requests, briefingpackages, annual reports, and planning for marketing applications.
Collaborate with regulatory authorities and external advisors to advance developmentprograms and maintain compliance.
Ensure alignment of development activities with regulatory expectations and corporateobjectives.
Quality Assurance & Compliance
Oversee Quality Assurance leadership, company-wide quality systems and complianceprocesses.
Responsible for compliance with GCP, GLP, GMP, ICH guidelines, FDA regulations, andother applicable global regulations.
Promote a culture of quality, continuous improvement, and operational excellence

Manufacturing, CMC & Supply Chain
Responsible for oversight of CMC team, consultants, development, manufacturingoperations, supply chain activities, and external CDMO relationships.
Ensure timely delivery of clinical supplies and initiate commercial supply planning inaccordance with timelines, budgets, and quality requirements.
Direct CMC team to support process development, technology transfer, scale-up activities,and manufacturing readiness.
Continuously assess and mitigate manufacturing and supply chain risks.
Program Management
In charge of establishing, updating and managing integrated development plans and cross-functional processes.
Ensure alignment of clinical, regulatory, quality, nonclinical, and manufacturing activities.
Continuously monitor program timelines, contracts, budgets, resource allocation, and criticalpath activities.
Lead program processes and executive portfolio reviews.

Financial & Business Operations
Partner closely with the Chief Financial Officer and Finance team on budgeting, forecasting,and operational expenditures.
Support annual planning processes and long-range strategic planning.
Establish financial processes across operational functions.
Implement outsourcing strategies and resource allocation decisions.
Contribute to Board presentations, investor discussions, due diligence activities, and businessdevelopment initiatives

External Partnerships
Build and maintain productive relationships with CROs, CDMOs, consultants, academicinstitutions, investigators, and strategic partners.
Support business development, PR, alliance management, and partnership activities asneeded.
Represent the Company in interactions with investors, regulators, partners, and industryorganizations

Preferred Qualifications and Experience

Education and Experience
Advanced scientific degree (RN, PhD, PharmD, MD, MS) or equivalent experiencepreferred.
MBA or business management training strongly preferred
10+ years of progressive leadership experience in biotechnology, pharmaceutical, or lifesciences organizations.
Significant experience overseeing multiple development functions, including clinicaloperations, regulatory affairs, quality, and manufacturing.
Demonstrated success leading programs through IND-enabling activities, through all clinicalstages of development (from Phase 0 to III), and regulatory interactions.
Experience operating within emerging-growth or publicly traded biotechnology companiespreferred.
Proven experience managing outsourced development and manufacturing networks.

Languages

Education

Contract Type

Salary Range

The final offer will be determined within the applicable location-specific range and will depend on the candidate's confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.