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About Our Trailblazing Biotech Partner
Join a visionary biotech company based in Washington, D.C., that is redefining the landscape of cancer treatment through cutting‑edge immuno‑oncology research. Our client is an emerging leader with a robust pipeline of innovative therapeutics that target novel immune pathways, aiming to transform the lives of patients worldwide. Backed by top‑tier venture capital, strategic collaborations with leading academic institutions, and a culture that celebrates scientific curiosity, the organization is poised for rapid growth and impact. As part of this dynamic team, you will be at the forefront of translating groundbreaking pre‑clinical discoveries into life‑changing clinical solutions.
Why This Role Is a Game‑Changer for Your Career
In the rapidly evolving biotech arena, the bridge between laboratory breakthroughs and patient‑centric trials is critical. As an Entry‑Level Clinical Development Director, you will own that bridge for pre‑clinical immuno‑oncology assets, guiding them from proof‑of‑concept studies through early‑phase clinical development. This position offers you a rare blend of strategic oversight, hands‑on project execution, and cross‑functional collaboration—all while operating within a supportive, mentorship‑driven environment. Whether you are based at the company’s hybrid hub or working remotely, you will receive the tools, training, and exposure needed to accelerate your professional trajectory.
Core Responsibilities – Driving the Clinical Journey
- Strategic Leadership: Design, refine, and execute the clinical development strategy for each pre‑clinical immuno‑oncology asset, aligning scientific potential with regulatory realities.
- Pre‑Clinical to Clinical Transition: Partner closely with discovery scientists to translate mechanistic insights into clinically viable development plans, including IND‑ready documentation.
- Regulatory Navigation: Assemble, review, and submit key regulatory dossiers (INDs, CTAs, amendments) while ensuring compliance with GCP, ICH, and FDA/EMA guidelines.
- Biomarker & Patient Selection Strategy: Define and implement biomarker strategies that enhance patient stratification, improve trial efficiency, and support companion diagnostic development.
- Cross‑Functional Collaboration: Act as the central clinical liaison for pre‑clinical, translational, regulatory, and commercial teams, fostering seamless communication and shared objectives.
- External Partnerships: Build and manage relationships with academic investigators, CROs, and key opinion leaders to secure clinical sites, enrollment, and scientific credibility.
- Data Oversight & Interpretation: Provide medical oversight on early clinical data, synthesizing safety, pharmacokinetic, and pharmacodynamic findings to inform go/no‑go decisions.
- Scientific Communication: Contribute to internal updates, board presentations, conference abstracts, and peer‑reviewed publications that highlight program milestones.
Essential Qualifications – The Foundation of Success
- Medical Degree (MD) or Equivalent: Preference for candidates with a specialization in oncology, immunology, or related translational fields.
- Industry Experience: 0‑5 years of hands‑on experience in clinical development, preferably within biotech or pharmaceutical settings focused on oncology.
- Clinical Trial Design Acumen: Proven ability to conceptualize, design, and oversee early‑phase (Phase I/II) clinical studies, including dose‑escalation and safety assessment.
- Regulatory Knowledge: Familiarity with FDA, EMA, ICH, and GCP regulations, as well as experience drafting INDs, CTAs, and related filings.
- Scientific Literacy: Strong understanding of immuno‑oncology mechanisms, pre‑clinical models, and biomarker development.
- Communication Skills: Exceptional written and verbal communication, capable of translating complex scientific concepts for diverse audiences.
Preferred Extras – What Will Set You Apart
- Post‑doctoral training or fellowship experience in oncology or immunology research.
- Previous exposure to IND‑enabling studies, GLP toxicology, or GMP manufacturing processes.
- Experience collaborating with contract research organizations (CROs) and academic research centers.
- Demonstrated track record of scientific publications or conference presentations in oncology.
- Project management certification (e.g., PMP) or formal training in agile/lean methodologies.
Critical Skills & Competencies for High Performance
- Strategic Thinking: Ability to see the big picture while managing granular details of clinical program execution.
- Team Leadership: Skill in motivating cross‑functional teams, driving accountability, and fostering a collaborative environment.
- Problem Solving: Resourcefulness in addressing unforeseen scientific, regulatory, or operational challenges.
- Adaptability: Comfort with a fast‑paced, evolving biotech landscape where priorities shift rapidly.
- Ethical Judgment: Commitment to patient safety, data integrity, and regulatory compliance.
- Digital Proficiency: Familiarity with electronic trial master file (eTMF) systems, data management platforms, and remote collaboration tools.
Pathways for Growth – Your Future with the Company
Our client invests heavily in talent development. As a Clinical Development Director, you will have access to:
- Mentorship from senior scientific leaders and seasoned clinical directors.
- Funding for external conferences, workshops, and continuing education in oncology and regulatory affairs.
- Clear promotion pathways to Senior Director, Vice President of Clinical Development, or functional leadership roles within the broader organization.
- Opportunities to lead independent programs, manage larger portfolios, and influence corporate strategy.
Work Environment & Culture – Where Innovation Thrives
Our client champions a hybrid work model that balances the flexibility of remote work with the collaborative energy of in‑office days (four days per week). The workplace is characterized by:
- Open‑plan laboratories and meeting spaces that promote interdisciplinary brainstorming.
- Regular “science cafés,” journal clubs, and lunch‑and‑learn sessions that keep the team abreast of the latest research.
- Diversity, equity, and inclusion (DEI) initiatives that ensure all voices are heard and valued.
- Well‑being programs, including mental‑health resources, fitness memberships, and flexible scheduling to support work‑life harmony.
Compensation, Perks & Benefits – Recognizing Your Contributions
While exact figures vary based on experience, the role offers a competitive salary benchmarked against industry standards, complemented by a comprehensive benefits package that typically includes:
- Health, dental, and vision insurance with generous employer contributions.
- Retirement savings options (401(k) with matching contributions).
- Equity participation or stock‑option plans, aligning your success with company growth.
- Paid time off, parental leave, and holiday schedules.
- Professional development allowances, tuition reimbursement, and access to internal training modules.
- Relocation assistance for those transitioning to the Washington, D.C. area, if desired.
How to Apply – Take the Next Step in Your Career
If you are an ambitious, medically qualified professional ready to shape the future of cancer immunotherapy, we want to hear from you. Submit your résumé, a tailored cover letter outlining your relevant experience, and any supporting publications or presentations that showcase your scientific acumen.
Ready to Apply?
Click the link below to begin your application journey. Our recruitment team reviews each submission promptly and will be in touch to discuss next steps.
Apply to This Position
Embark on a career where your expertise drives real‑world impact, and where every day brings you closer to delivering life‑saving therapies to patients in need.
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