OverviewThe Vice President, Clinical & Development Sciences will serve as a senior medical and scientific leader within Celldex's Clinical organization and a key partner to the Chief Medical Officer. This individual will provide strategic leadership across clinical development programs, helping shape and execute development strategies designed to advance Celldex's portfolio from proof of concept through late-stage development leading to regulatory approval, and in the post-marketing phase.
The Vice President will provide 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.. They will partner closely with other Celldex leaders on regulatory strategy and interactions, scientific communications, and engagement with the medical community.
As a senior leader within Clinical Development, this individual will work closely with Clinical Operations, Regulatory Affairs, Clinical Pharmacology and Pharmacometrics, Translational Medicine, Biostatistics, Data Management, Pharmacovigilance and Risk Management and other functions to ensure integrated development strategies and high-quality execution. They will also partner with Medical Affairs and the Commercial Team to support scientific communications and evidence generation, and to ensure alignment of clinical development strategies with the needs of the medical community and patients.
The Vice President will also play an important leadership role in building and developing the Clinical Development organization, mentoring clinical development and clinical science talent, and establishing the capabilities required to support Celldex's advancing pipeline.
Responsibilities
Clinical Development Strategy & Leadership
- Provide senior medical and scientific leadership for Celldex clinical development programs from early development through Phase 4, with particular emphasis on late-stage development (Phase 2-4).
- Oversee the creation of 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 overall 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.
Clinical Trial Strategy & Execution
- Provide medical leadership for the design, planning, execution and interpretation of Phase 1-4 clinical trials.
- Lead or provide senior oversight for the development of clinical protocols, amendments and supporting clinical documents.
- Partner closely with Development Operations to ensure studies are executed on time and to high standards of quality.
- Direct the clinical development team in providing medical oversight and monitoring of clinical studies, including patient safety, eligibility questions, protocol implementation and emerging clinical data.
- Participate in and provide medical leadership (in partnership with Pharmacovigilance and Risk Management, for safety monitoring activities, including data and safety monitoring committees and adjudication committees where appropriate.
- Ensure clinical data collection and analysis support strategic, scientific and regulatory objectives.
Data Interpretation & Scientific Communication
- Lead the 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.
Regulatory & Development Strategy
- Partner with Regulatory Affairs to develop clinical regulatory strategies supporting advancement and potential approval of Celldex programs.
- 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 FDA, EMA and other global health authorities.
- Help anticipate clinical and regulatory development risks and establish strategies to address them.
External Scientific Leadership
- 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 designed to inform development strategy.
- Evaluate external clinical research opportunities and proposals involving Celldex programs.
- Work collaboratively with CROs, academic institutions and other development partners to support successful execution of clinical programs.
- Serve as a senior medical and scientific representative of Celldex with external stakeholders.
Organizational Leadership
- Provide leadership, mentorship and development to clinical development physicians and clinical scientists.
- Build strong cross-functional partnerships and promote an integrated approach to clinical development.
- Help build organizational capabilities, processes and talent required 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.
Qualifications
- Board certification or advanced clinical training in allergy, immunology, dermatology preferred but would also consider another relevant specialty.
- Minimum 10 years of clinical development experience within biotechnology and/or pharmaceutical companies preferred, with significant leadership responsibility.
- Prior experience leading clinical development for a commercial-stage product, including progression through Phase 3, regulatory submission and approval, commercialization, and Phase 4/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; experience spanning early through post-approval development strongly preferred.
- Experience developing biologic therapies and/or treatments for immunologic, inflammatory, allergic or mast cell-driven diseases strongly preferred.
- Demonstrated experience with regulatory submissions and interactions with FDA and/or other global health authorities.
- Demonstrated experience leading and developing physicians, clinical scientists and/or multidisciplinary clinical-development teams.
- Experience working within both larger pharmaceutical organizations and entrepreneurial biotechnology environments is a plus.
- Exceptional clinical and scientific judgment with the ability to translate science into actionable development strategy.
- Demonstrated 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.
- Demonstrated ability to make sound decisions in complex situations with evolving or incomplete clinical data.
- Proven 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 fast-paced small company environment.
- Ability to travel up to 25%
Compensation StatementThe expected base salary for this position is: $401269.00 to $493561.00. 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. Subject to eligibility and applicable plan terms, compensation 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
