Sr. Director, Clinical Operations

We need to output HTML fragment with sections: About the role? Actually we need to use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include only sections where posting has real specific content. We need to extract content. We have company summary, position summary, key responsibilities, required qualifications, preferred qualifications, values and behaviors, recruitment & staffing agencies (boilerplate to remove), salary range, benefits statement, privacy notice (boilerplate). We need to remove cookie/navigation/legal/EEO etc. Also remove duplicated lines. We need to produce sections: maybe About the role (position summary), Responsibilities (key responsibilities), Requirements (required qualifications), Qualifications (maybe preferred qualifications?), Skills (maybe values and behaviors?), Benefits (benefits statement), Pay (salary range), Schedule (maybe not present). There's no explicit schedule info, so we should not include Schedule section. We must not repeat job title as heading. The page already shows it, so we don't add a heading for job title. We need to preserve all substantive information, not invent or summarize away detail. So we need to include the content as is, but we can format into

or

• . For responsibilities, we should list each bullet as
• . For qualifications, list each bullet. For preferred qualifications maybe as separate section? The instruction says use headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. It seems they expect these specific headings. We can map: - About the role: position summary (maybe also company summary? but they said About the role section heading). We'll put position summary there. - Responsibilities: key responsibilities. - Requirements: required qualifications. - Qualifications: preferred qualifications? Or maybe they want qualifications separate from requirements. We'll put preferred qualifications under Qualifications. - Skills: values and behaviors? Or maybe skills from responsibilities? But we have values and behaviors section describing entrepreneurial spirit etc. That could be Skills. - Benefits: benefits statement. - Pay: salary range. - Schedule: not present, so omit. We must not include headings with filler text. So we will only include those sections that have content. We need to remove boilerplate: recruitment & staffing agencies, privacy notice, EEO etc. Also remove duplicated lines. We need to preserve all substantive information: company summary maybe not needed? The instruction says use headings for sections; company summary could be part of About the role? But they said About the role for section headings (e.g. About the role, Responsibilities...). So we can include company summary under About the role as well, but maybe better to include it as part of About the role (position summary). However they said preserve ALL substantive information; we should not drop company summary. So we can include company summary in About the role paragraph. Thus About the role will contain company summary + position summary. Now we need to format. We'll produce:

  About the role

  Company summary... Position summary...

  But we need to avoid too long paragraph? It's okay. Responsibilities:

  Responsibilities

  • ...
  ... etc. We need to extract each responsibility bullet from "Key Responsibilities". Let's list them: - Lead clinical operations planning and execution for early development programs, with primary accountability for first-in-human study readiness, global start-up, and delivery against key milestones. - Develop and maintain integrated study plans, timelines, budgets, forecasts, resource requirements, and risk-mitigation strategies aligned with clinical and corporate objectives. - Lead CRO and vendor selection and oversight, including requests for proposals, bid evaluations, scope-of-work development, budget negotiations, change-order management, performance monitoring, and issue escalation. - Partner with Clinical Development and Medical leadership to evaluate protocols, study designs, operational feasibility, and start-up requirements. - Represent Clinical Operations on cross-functional study and program teams, partnering with other relevant functions internally and externally (e.g., Clinical Development, Regulatory, Safety, Clinical Pharmacology, Data Management, Biostatistics, Bioanalytical, CMC, Quality, and clinical supply colleagues). - Develop and execute the Phase 1 site strategy, including the identification, qualification, activation, and ongoing management of sites with appropriate participant access, clinical pharmacology capabilities, bioanalytical infrastructure, and operational experience. - Lead global clinical operations activities across the U.S., Europe, Australia, and other ex-U.S. regions, accounting for applicable regulatory, ethics, site, laboratory, vendor, and country-specific start-up requirements. - Contribute to operational planning for potential studies in China and coordinate with internal and external experts to support regional requirements. - Establish an effective operating cadence with CROs, sites, vendors, consultants, and functional partners to track deliverables, timelines, budgets, quality metrics, risks, and escalation paths. - Oversee the development and maintenance of study-level operational documentation, including monitoring, communication, enrollment, vendor-oversight, and risk-management plans. - Partner with CMC and clinical supply stakeholders to support investigational product packaging, labeling, distribution, accountability, and site readiness. - Ensure clinical studies are conducted in accordance with the protocol, ICH-GCP, applicable regulatory requirements, internal procedures, and established quality standards. - Maintain inspection-ready clinical trial documentation and oversee the completeness, quality, and timeliness of the Trial Master File. - Identify operational risks early and implement mitigation and contingency plans related to timelines, sites, enrollment, vendors, clinical supply, and data delivery. - Establish scalable, fit-for-purpose clinical operations processes, systems, SOPs, and governance practices appropriate for a growing biotechnology company. - Provide clear and timely updates on study status, timelines, budgets, risks, and mitigation plans to the CMO, clinical leadership, and other key stakeholders. That's many bullets. Now Required Qualifications bullet list: - BS/MS/PhD degree in a scientific, healthcare, or related discipline; an advanced degree is preferred. - 10+ years of progressive clinical operations experience in the biotechnology or pharmaceutical industry. - Direct experience leading first-in-human or Phase 1 studies from operational planning and vendor selection through regulatory and ethics submissions, site activation, first-participant-in, and ongoing execution. - Strong working knowledge of CRO and vendor selection and oversight, site strategy, global study start-up, and operational planning. - Demonstrated experience managing study budgets, vendor contracts, scopes of work, change orders, timelines, and forecasts. - Experience reviewing clinical protocols and translating study designs into executable operational plans. - Experience supporting clinical pharmacology/DMPK, including dose-escalation, SAD/MAD, biomarker, or other early-phase study designs, as applicable. - Experience conducting studies involving [healthy volunteers/specific patient population-to be completed based on the planned first-in-human study]. - Broad understanding of FDA, EU, and other ex-U.S. clinical trial requirements. - Strong knowledge of ICH-GCP, sponsor oversight responsibilities, TMF requirements, clinical quality standards, and inspection readiness. - Ability to operate independently and influence without direct authority in a fast-paced environment with limited infrastructure and high levels of ambiguity. - Strong communication and cross-functional collaboration skills, with the ability to manage internal stakeholders, external vendors, and consultants effectively. - Ability and willingness to travel domestically and internationally, as needed. Note: The bracket "[healthy volunteers/specific patient population-to be completed based on the planned first-in-human study]" is placeholder; we should keep it as is? It's substantive? It's a placeholder but it's part of the posting. The instruction says do not emit heading followed by filler/placeholder text like "commensurate with experience", "not specified", "N/A", "varies", "TBD". This is a placeholder but it's inside a bullet. Should we keep it? It's not a heading; it's inside a bullet. The instruction about filler text applies to sections, not necessarily bullet content. However we should preserve all substantive information; this is placeholder but it's part of the posting. I'd keep it. Preferred Qualifications bullet list: - Experience in both biotechnology and pharmaceutical company environments, with exposure to the broader clinical development lifecycle. - Direct experience initiating and executing early-phase studies in Australia, including familiarity with local regulatory, ethics, site, and vendor pathways. - Experience with China regulatory and clinical operations pathways. - Experience in antibody therapeutics, biologics, or other advanced therapeutic development programs. - Experience operationalizing biomarker, immunogenicity, pharmacokinetic, pharmacodynamic, or other specialized sample-collection and bioanalytical strategies within early-phase studies. - Experience establishing clinical operations infrastructure, processes, systems, and external partnerships within an organization entering the clinic for the first time. Values and Behaviors bullet list (maybe as Skills): - We are seeking individuals with an entrepreneurial spirit, strong communication skills, and comfort working in and contributing to a dynamic and cross-functional team environment. - The level of the role will be commensurate with the education and years of experience of the identified candidate. - At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. - Experience comes in many forms, skills are transferable, and passion goes a long way. - We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background. But note: some of these are filler? "The level of the role will be commensurate with the education and years of experience of the identified candidate." That is somewhat filler but it's a statement. It's not a heading. We'll keep. Now Benefits: "Metaphore Biotechnologies, Inc. currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits." Pay: "The salary range for this role is $213,000 - $280,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience." We should include that as Pay section. Now we need to ensure we don't include any boilerplate like recruitment & staffing agencies, privacy notice, etc. Now produce HTML. We need to wrap each section in

  heading and then content. For About the role: we can put two paragraphs: company summary and position summary. Or combine. Let's craft:

  About the role

  Metaphore Biotechnologies, Inc. is a privately held biotechnology company building the next generation of biological therapeutics. Inspired by nature, our mission is to transform patient lives by unlocking the power of biological therapeutics with a new proprietary discovery platform. Metaphore’s platform brings together live-cell experimentation and AI/ML to understand how biological mechanisms drive functional outcomes in living systems. By capturing these mechanism-function relationships, Metaphore aims to design antibody medicines with intended activity from the start.

  Metaphore Biotechnologies is seeking a Senior Director of Clinical Operations to lead the hands-on execution of early clinical development activities for the company’s first-in-human program. Reporting to the Chief Medical Officer, this is a senior individual-contributor role with broad ownership and visibility across the organization. This individual will own clinical operational planning and study execution encompassing CROs and vendor management, site strategy, protocol feasibility, regulatory coordination, and global study start-up, with particular focus on Phase 1 readiness and execution. The successful candidate will be highly operational, able to ramp quickly, and comfortable establishing fit-for-purpose capabilities while working across internal teams, external partners, and consultants to move studies forward with urgency and rigor.

  Now Responsibilities:

  Responsibilities

  • Lead clinical operations planning and execution for early development programs, with primary accountability for first-in-human study readiness, global start-up, and delivery against key milestones.
  • Develop and maintain integrated study plans, timelines, budgets, forecasts, resource requirements, and risk-mitigation strategies aligned with clinical and corporate objectives.
  • Lead CRO and vendor selection and oversight, including requests for proposals, bid evaluations, scope-of-work development, budget negotiations, change-order management, performance monitoring, and issue escalation.
  • Partner with Clinical Development and Medical leadership to evaluate protocols, study designs, operational feasibility, and start-up requirements.
  • Represent Clinical