Senior Manager/Associate Director, Clinical Study Lead

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking a Clinical Study Lead that will ensure clinical strategies are translated into operational plans and executed in line with clinical development plans (CDPs). You are responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives including aligning operational execution activities with agreed upon project priorities, timing, budget, and quality requirements. You will also ensures study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Crescent’s policies and SOPs.

Responsibilities:
• Manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations
• Develop study level operational strategy and clinical operations plans in support of execution of the Program-level objectives/CDP
• Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
• Support the selection, oversight, and management of CROs and other vendors
• Monitor and assess vendor performance against contractual operational deliverables
• Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors
• Provide oversight of study scope, quality, timelines and budget with internal Crescent functional leads, CRO and vendors to ensure project objectives remain on track
• Lead cross-functional teams and manage study teams in partnership with the CRO
• Participate in a site engagement program to builds solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities
• Responsible for planning and conducting investigator meetings together with the CRO
• Partner with the CRO to ensure patient enrollment strategies are carried out effectively and on time
• Coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data
• Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required
• Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always “inspection ready”
• Prepare high-quality reports (financial, project, etc.) for senior management on program status and issues as required
• Provide management, oversight, coaching, mentoring, and development to team of indirect reports supporting the clinical trials team and cross-functional teams

Education & Experience:
• Bachelor’s degree in a scientific or health-related field, advanced degree preferred
• 6+ years of drug development and clinical operations experience, including biotech/pharma environments; including conducting Phase I-III global clinical trials, preferably in a clinical-stage biotechnology company managing outsourced clinical trials within quality, timeline and budget expectations; Prior site and/or monitoring experience is advantageous
• Experience across several complex therapeutic areas; neuromuscular or muscle disease experience preferred. Experience with rare disease and/or pediatric trials also preferred
• Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws
• Understand clinical study budgets, accruals and forecasting
• Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously
• Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish relationships
• Experience in vendor selection and overseeing studies being managed by a CRO
• Ability to successfully engage and work collaboratively with clinical operations team members/colleagues and other functions, including Medical Affairs and Commercial, as necessary
• Demonstrated ability to problem solve and use clear judgments in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• This role is expected to require up to 20% travel, including international travel

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What We Offer:
• Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
• Competitive compensation, including base salary, performance bonus, and equity
• 100% employer-paid benefits package
• Flexible PTO; also, two, one-week company-wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities

About us:
• Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates (ADCs). By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.