Exec Med Dir, Clinical Dvlpmt

Date Posted: 8/20/2026

Executive Medical Director, Clinical Development
onsite / hybrid
Morris County, NJ

Top Pharmaceutical Company NJ Morris County, New Jersey, United States (Hybrid)

One of our clients within he Biotech/Pharma industry, is searching for an Executive Medical Director in Clinical Development in the Oncology space (myeloma disease area). They are seeking someone with experience in development and oversight of cell therapy programs, collaboration with external partners to support evaluation opportunities for expanding the clinical development program to where you will lead a portfolio of clinical trial programs in cell therapy clinical development. This position will have a team of direct reports.

Daily responsibilities include the following:
Lead the development, implementation, and execution of the clinical development strategy, which will include development of the Target Product Profile and Clinical Development Plan. Design, conduct, evaluation, close out and reporting of clinical trials across the portfolio. Leadership or oversight responsibilities include, study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations. Lead, oversee and directs development of the Target Product Profile and Clinical Development Plan for assigned molecules & products. Work with cross functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules & products. Leads directs clinical trial protocol design and clinical study reporting for assigned molecules & products. Represents the assigned products in cross functional steering and governance committees. Lead both written and oral communications with health authorities. Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance. Manage the clinical development components in the preparation, review of regulatory documents, investigator brochures and development plans. Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and review of data listings, summary tables, study results and scientific presentations. Presents scientific information at scientific conferences as well as clinical study investigator meetings. Takes a lead on authoring scientific publications. Assist in the clinical evaluation of business development opportunities. Develop external relationships that can guide short and long range clinical development strategies and direction for the disease or therapeutic area. Adheres to regulatory requirements inclusive of GCP and ICH guidelines of study conduct, and industry practices and standards including internal SOPs.

Required:
MD/DO and 7+ years of clinical, scientific or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment. Board certification in hematology or medical oncology is preferred, familiar with clinical oncology. MUST HAVE experience within the Biotech/Pharma industry that includes submissions and phase II-III late development studies. MUST HAVE current Oncology experience, multiple myeloma disease and cellular therapy is strongly preferred. Extensive experience leading high complex cross functional drug development strategies and plans in life sciences. Must have a minimum of 3 years’ line management (direct reports) experience. Experience interacting with and presenting to executives and managing large-scale budgets and other resources. Strong knowledge of drug development, proven track record in setting short and long range drug development strategies and plans. Must have thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.

Please contact Darren Gutowski at dgutowski@clarkdavis.com