<p>Overview</p> <p>The Executive Director of Clinical Science is a key member of the Clinical Science Leadership Team and provides leadership, clinical strategy and direct oversight of clinical science deliverables, including overseeing the clinical scientists to ensure the design, data collection, and reporting of clinical studies is timely and consistent with high quality standards, applicable regulations and Celldex's overarching clinical development strategy.</p> <p>Responsibilities</p> <ul> <li> <p>Lead, develop and manage a highly functional, productive, collaborative team of clinical scientists to ensure efficiency, quality, consistency and the achievement of timely deliverables across the programs, including but not limited to:</p> </li><li> <p>Create and train on standardized clinical science working processes</p> </li><li> <p>Establish cross-functional collaboration with colleagues in clinical development, clinical operations, medical affairs, regulatory affairs, commercial organizations as well as external physicians, expert consultants, and contracted vendors</p> </li><li> <p>Support medical directors in generation of strategic clinical development plans</p> </li><li> <p>Play a leadership role in the design of Phase 1-4 clinical studies</p> </li><li> <p>Own and manage the generation and drafting of key documents, including protocols, protocol amendments, IBs, CSRs, and clinical regulatory submissions</p> </li><li> <p>In collaboration with regulatory colleagues, compile submissions including clinical data summaries/analyses, such as briefing packages.</p> </li><li> <p>Leads clinical science contributions to BLA submission, including drafting content</p> </li><li> <p>Oversee the review, analysis, and reporting of clinical data in collaboration with medical directors to enable internal decision making and regulatory filings</p> </li><li> <p>Provide input into statistical analysis plans and data displays in accordance with regulatory and strategic objectives. Ensure data collection is consistent with/supportive of protocol and analysis plans.</p> </li><li> <p>Contribute to data cleaning efforts by performing clinical data reviews and providing training feedback to the Clinical Operations Team; provide guidance for issues that may impact clinical trials data generation, collection, and analysis</p> </li><li> <p>Participate in planning for interim data analyses and reviews, including Data Monitoring Committee (DMC) meetings</p> </li><li> <p>Own the development of Celldex scientific clinical presentations and publications (message development, message integration, content drafting, layout, internal and external review process, submission and speaker preparation), including but not limited to abstracts, presentations at medical/scientific meetings and manuscripts</p> </li><li> <p>Hire, onboard, train, manage, and develop clinical scientist team</p> </li><li> <p>Manage clinical scientist resourcing across programs</p> </li><li> <p>Assumes responsibility for individual deliverables as needed.</p> </li></ul> <p>Qualifications</p> <ul> <li>MS/MA degree or equivalent in a scientific or health care field required. PhD's preferred. </li><li>10-15 years of experience in clinical research setting, including medical writing, protocol development, and oversight of (or close collaboration with) data management/analysis/reporting functions. </li><li>Extensive experience authoring clinical protocols, regulatory documents (IND sections, clinical study reports, investigator brochures), as well as scientific publication and presentations. </li><li>Experience with preparation of BLA </li><li>At least 4 years of experience in immunology & inflammation preferred </li><li>Demonstrated experience designing and executing clinical trials in all phases of clinical development, (Phase 1-3, post-marketing) </li><li>Proven ability to design and execute clinical development plans and interpret data for decision-making and external communication. </li><li>Strong knowledge of GCP and the end-to-end drug development process, including nonclinical, CMC, regulatory, pharmacovigilance, data management and clinical operations. </li><li>Experience recruiting, training, mentoring, managing and leading highly functional, productive teams. </li><li>Strategic thinker with an execution-focused mindset, well suited for a lean biotech environment. </li><li>Ability to work in an agile, fast paced environment. </li><li>Excellent written and verbal communication skills, with the ability to influence internal and external stakeholders. </li><li>Excellent project management skills. </li></ul> <p>Compensation</p> <p>The expected base salary range for this position is $233,631 to $303,417.</p> <p>We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.</p> <p>Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.</p> <p>Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.</p>