Director of Clinical Operations

Written By Jamison Wright

Join a fast-paced, collaborative, cutting-edge start-up biotechnology company developing the next generation of therapeutic bispecific antibodies focused on extracellular protein degradation. Our mission is to generate novel transformative medicines for the patients that need it most. The Director of Clinical Operations will provide strategic leadership in support of our clinical development vision and manage and execute one or more first in human phase I-II global clinical trials. The ideal candidate must be able to manage all clinical operational aspects of one or more clinical trials. Experience in Early Phase clinical trial management is preferred, including study start-up activities, patient enrollment initiatives, study maintenance, and close-out. The applicant must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, develop SOPs, etc. We are seeking an experienced leader capable of providing strategic insights and technical expertise while navigating a complex global clinical trial landscape. The candidate must maintain a balance between ensuring the highest quality standards and driving the vision for our platform under aggressive timelines.

Day-to-day responsibilities may include:

  • Provide leadership and oversight in all aspects of clinical operations, from planning and executing programs to project oversight

  • Provide strategic operational input to Clinical Development Plan (CDP) and project plans

  • Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics, timelines, and critical study activities

  • Creating and overseeing clinical trial budget

  • Develop and maintain enrollment forecasts

  • Identifying, assessing, and selecting study sites/PIs in partnership with CMO and Vendors (as applicable)

  • Manage CROs and third-party vendors to ensure delivery against the contracted scope of work and budget

  • Assist in executing and managing legal contracts from clinical sites, vendors, etc., in conjunction with outside legal counsel

  • Participate in selecting CRO and vendors, including developing RFPs, budget negotiations, and management

  • Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA, and contribute to IND filings

  • Develop and assure compliance with SOPs, local regulations, and CFR, ICH, and GCP guidelines.

  • Ensure development study plans and provide adequate oversight for vendor oversight, risk, safety, and communication

  • Ensure ongoing TMF and data collection are on track and maintaining quality

  • Drive & support preparation for data cleaning and cuts

  • Study specific participation in system set-up for key systems (e.g., IVRS, EDC, TMF, other)

  • Plan and oversee Investigator Meetings as applicable

  • Provide supervision, coaching, and mentoring and contribute to hiring new staff.

  • Ensuring cross-functional team project-specific training

  • Hosting, documenting, and filing internal /external project team meetings

  • Assess project risk through life of project and escalate/ problem solve as needed

  • Proactively identify risks and develop and implement mitigation strategies

  • Self-motivated and able to thrive in a fast-paced, start-up environment

  • Plan, participate, and facilitate operational-level governance with vendors as appropriate

  • Ensure timely and effective risk mitigation and escalation for projects and programs

  • Provide senior executive management with project and program updates

  • Leads collaborative teams for projects or groups both internal and external to business and across functional areas. Reacts well under pressure. Develops subordinates' skills and encourages growth by providing relevant feedback and coaching. Carries out required performance management processes responsibilities and actively supports employee development. Identifies and manages disciplinary situations or employee conflict.

Other Duties:

  • Travel to client or prospect locations, conferences, or other professional development and networking events

Required Education / Experience and Skills:

  • Bachelor’s degree or equivalent is required

  • Must have at least 10 years of relevant trial leadership experience in either sponsor or CRO

  • Phase I-II Global Trial Management experience

  • Strong track record for successful study initiation and execution

  • Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE, and other relevant guidelines and regulations

  • Experience managing CROs and third-party vendors

  • Experience in Finance Management, including but not limited to Budget Forecasting, Change Order Management

  • Experience working with EDC, CTMS, and eTMF systems

  • Strong interpersonal communication skills

  • Able to prioritize critical business needs

  • Able to engage in strategic business discussions and craft executive-level communications and materials

  • Excellent cross-functional clinical project management skills

  • Must have exceptional leadership skills, including motivation and delegation

Job level will be based on prior experience and accomplishment. The expected base salary range for the Director of Clinical Operations role is $202,500-$247,500.

The above pay range is what we reasonably expect to pay for this position.  Individual compensation is based on various factors, including experience, education, skillset, and geographic location.  This pay range is for the Bay Area, CA, location and may be adjusted to the labor market in other geographic areas. 

Benefits & Perks: 

  • Comprehensive and competitive health, vision, dental, life insurance

  • Competitive base pay, bonus, and equity package 

  • Unlimited PTO, Paid Holidays and Winter Break 

  • 10 weeks Parental Bonding Leave

  • Epi 401(k) Plan 

EpiBiologics is an Equal Opportunity Employer:

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you think you will excel in this role, but perhaps don’t tick every box, we encourage you to apply!

Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation. 

Jamison Wright https://jamisonwright.com
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