Executive Director Clinical Development

Executive Director Clinical Development

Greater Philadelphia Area - Hybrid

Compensation: $340,000-360,000 + 30% bonus + Lucrative RSU package

Company Summary:

This biotechnology organization operates as a focused, innovation‑driven R&D hub supported by a large, financially robust global life‑sciences parent company. The broader group has a long track record of successful drug development, multiple FDA‑approved therapies, and stable commercial revenues reaching into the hundreds of millions annually. This unique structure provides the best of both worlds: the agility and scientific depth of a small biotech, combined with the resources, infrastructure, and long‑term stability of a major multinational enterprise.

Within this environment, the company is advancing a first‑in‑class oncology program poised to transition from preclinical development into the clinic. Scientific excellence is at the core of the organization's mission, and teams collaborate closely across discovery, translational science, and early‑stage clinical development to drive meaningful innovation in cancer therapy. Leaders joining this group have the rare opportunity to directly shape translational strategy, influence pipeline evolution, and contribute to the development of next‑generation oncology treatments at a formative stage.

This is an ideal setting for individuals who value impact, scientific rigor, and the chance to help guide a promising therapeutic program toward first‑in‑human studies, within a company built for both long‑term success and meaningful scientific contribution.

Responsibilities:

• Provide scientific and clinical leadership to preclinical oncology programs.
• Work closely with discovery and nonclinical teams to ensure alignment across biological rationale, preclinical data packages, and early‑stage clinical strategies.
• Contribute to the design, interpretation, and integration of:
• In vitro and in vivo efficacy studies
• Pharmacokinetic/pharmacodynamic and biomarker plans
• Translational endpoints that inform dose selection and first‑in‑human trial design
• Offer medical and scientific guidance on IND‑supporting activities, including toxicology and safety‑related studies.
• Support the development of translational and biomarker strategies that enable early signal detection and patient‑selection approaches in oncology trials.
• Participate in portfolio evaluations, including assessments of emerging oncology targets or external assets from a translational and clinical perspective.
• Contribute to comprehensive product development plans and clinical strategies informed by nonclinical and translational insights.
• Lead the design and execution of clinical trials and provide operational oversight in partnership with internal development teams and external collaborators.
• Provide clinical expertise to inform scientific strategy, program decisions, and cross‑functional discussions.
• Serve as the medical monitor for clinical studies or oversee monitoring activities performed by partners or vendors.
• Participate in safety monitoring activities, including SAE review, safety signal assessment, and ongoing evaluation of trial safety data.
• Support or lead the development and review of clinical protocols, Investigator Brochures, study reports, regulatory documents (IND/IMPD, NDA/MAA), safety reports, annual updates, SOPs, pediatric plans, abstracts, and scientific publications.
• Engage with regulatory authorities as needed throughout development and submission activities.
• Oversee scientific interactions with medical experts, advisors, and clinical investigators.
• Build and maintain strong relationships with investigators and key opinion leaders to support interest and engagement in clinical programs.
• Maintain compliance with Good Clinical Practice (GCP) and possess working knowledge of GLP and GMP as they relate to drug development.
• Understand global regulatory guidelines relevant to preclinical, translational, and clinical development activities.
• Experience with U.S. and international health authorities is preferred.
• Demonstrated ability to effectively collaborate with key opinion leaders and subject‑matter experts.
• Strong team‑oriented mindset, with the ability to work effectively in cross‑functional environments.

Qualifications:

• M.D. with subspecialty training in oncology preferred.
• Clinical practice experience is beneficial but not required.
• At least 5 years of clinical development experience within the pharmaceutical or biotechnology industry, ideally with oncology programs, or equivalent academic research experience.