Vice President, Clinical Science & Clinical Development

Celldex Therapeutics•Hampton, NJ

20h•$401,269 - $493,561

About The Position

The Vice President will serve as a senior medical and scientific leader within Celldex’s Clinical organization and as a key partner to the Chief Medical Officer. The role provides strategic leadership across clinical development programs, shaping and executing strategies to advance the portfolio from proof of concept through late-stage development and regulatory approval, as well as post-marketing development. The position provides medical and scientific leadership across clinical programs, including development strategy, clinical trial design and execution, medical monitoring and patient safety, and interpretation of clinical data. The Vice President partners with Celldex leaders on regulatory strategy and interactions, scientific communications, and engagement with the medical community. They work closely with Clinical Operations, Regulatory Affairs, Clinical Pharmacology and Pharmacometrics, Translational Medicine, Biostatistics, Data Management, Pharmacovigilance and Risk Management, Medical Affairs, and Commercial to support integrated development strategies, high-quality execution, scientific communications, and evidence generation. The Vice President also helps build and develop the Clinical Development organization, mentors clinical development and clinical science talent, and establishes capabilities needed to support Celldex’s advancing pipeline. The position requires an MD and prior leadership of clinical development for a commercial-stage product through Phase 3, regulatory submission and approval, commercialization, and Phase 4 or post-marketing clinical development. Travel may be required up to 25%.

Requirements

MD required.
Prior experience leading clinical development for a commercial-stage product through Phase 3, regulatory submission and approval, commercialization, and Phase 4 or post-marketing clinical development activities required.
Demonstrated experience developing clinical development strategies and leading the design, execution, and interpretation of clinical trials.
Significant Phase 2 and Phase 3 clinical development experience required.
Demonstrated experience with regulatory submissions and interactions with the FDA and/or other global health authorities.
Demonstrated experience leading and developing physicians, clinical scientists, and/or multidisciplinary clinical-development teams.
Exceptional clinical and scientific judgment, with the ability to translate science into actionable development strategy.
Ability to develop and execute clinical development plans across multiple stages of development.
Strong understanding of clinical trial design, execution, data interpretation, medical monitoring, and benefit-risk assessment.
Ability to operate credibly at a peer level with leading investigators, key opinion leaders, and scientific experts.
Strong understanding of the drug-development and regulatory process.
Ability to make sound decisions in complex situations with evolving or incomplete clinical data.
Ability to lead through influence and work effectively across highly matrixed, cross-functional teams.
Strong leadership and talent-development capabilities.
Excellent executive presence and oral and written communication skills.
Strong interpersonal, organizational, and strategic-planning skills.
Ability to balance strategic leadership with a willingness to remain close to the science, data, and programs.
Ability to thrive in a fast-paced small-company environment.
Ability to travel up to 25%.

Nice To Haves

Board certification or advanced clinical training in allergy, immunology, or dermatology; another relevant specialty may also be considered.
Minimum 10 years of clinical development experience within biotechnology and/or pharmaceutical companies, with significant leadership responsibility (preferred).
Experience spanning early development through post-approval development strongly preferred.
Experience developing biologic therapies and/or treatments for immunologic, inflammatory, allergic, or mast cell-driven diseases strongly preferred.
Experience working within both larger pharmaceutical organizations and entrepreneurial biotechnology environments is a plus.

Responsibilities

Provide senior medical and scientific leadership for clinical development programs from early development through Phase 4, with particular emphasis on Phase 2–4.
Oversee integrated clinical development plans that support program strategy, regulatory objectives, and potential commercialization.
Translate scientific and clinical insights into differentiated development strategies and trial designs.
Provide strategic guidance on indication selection, patient populations, endpoints, trial design, benefit-risk considerations, and development pathways.
Partner with the Chief Medical Officer and Clinical Leadership Team on portfolio strategy, program prioritization, and key development decisions.
Identify emerging scientific, clinical, and competitive developments that may influence clinical strategy.
Provide medical leadership for the design, planning, execution, and interpretation of Phase 1–4 clinical trials.
Lead or provide senior oversight for clinical protocols, amendments, and supporting clinical documents.
Partner with Development Operations to support timely, high-quality study execution.
Direct medical oversight and monitoring of clinical studies, including patient safety, eligibility questions, protocol implementation, and emerging clinical data.
Participate in safety-monitoring activities, including data and safety monitoring committees and adjudication committees where appropriate, in partnership with Pharmacovigilance and Risk Management.
Ensure clinical data collection and analysis support strategic, scientific, and regulatory objectives.
Lead medical and scientific interpretation of clinical trial data and emerging program findings.
Partner with Biostatistics, Data Management, and other functions on data review, analysis plans, and interpretation.
Provide oversight of clinical study reports and other key clinical documents.
Participate in publication planning and execution.
Represent Celldex and its clinical programs at scientific congresses, advisory boards, investigator meetings, and other external forums.
Partner with Regulatory Affairs to develop clinical regulatory strategies supporting program advancement and potential approval.
Provide medical and scientific leadership for regulatory submissions and clinical sections of INDs, BLAs, NDAs, briefing documents, annual reports, and other regulatory communications.
Participate in interactions with the FDA, EMA, and other global health authorities.
Anticipate clinical and regulatory development risks and establish strategies to address them.
Establish and maintain relationships with investigators, key opinion leaders, academic collaborators, and other external scientific experts.
Lead and participate in advisory boards and other scientific forums that inform development strategy.
Evaluate external clinical research opportunities and proposals involving Celldex programs.
Collaborate with CROs, academic institutions, and other development partners to support successful clinical program execution.
Serve as a senior medical and scientific representative of Celldex with external stakeholders.
Provide leadership, mentorship, and development to clinical development physicians and clinical scientists.
Build cross-functional partnerships and promote an integrated approach to clinical development.
Help build organizational capabilities, processes, and talent to support an expanding clinical-stage and late-stage pipeline.
Foster a culture of scientific rigor, collaboration, accountability, and urgency.
Represent the Chief Medical Officer and Clinical Development organization in key cross-functional forums, as appropriate.
Perform other responsibilities consistent with the scope and leadership expectations of the position.