This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
Job description
Senior (Executive) Medical Director (MD)
The MD will provide strategic leadership to develop a Clinical Development Plan (CDP) and oversee new product development from IND to submission. The role ensures program consistency and alignment across studies while working closely with cross‑functional teams to achieve project goals on time, on budget, and with high quality.
Major Responsibilities and Duties
Provide clinical leadership and strategic medical input for all clinical deliverables.
Design Comprehensive Development Plans (CDPs), clinical trials and protocols, and execute in accordance with GCP regulations.
Lead high‑quality planning and execution of external meetings and internal stakeholder meetings.
Define project timelines and deliverables, ensuring on‑time, on‑budget completion with the highest quality standards.
Identify project risks and support issue resolution.
Provide therapeutic area medical and scientific expertise to study teams and key stakeholders.
Anticipate trends in medicine and industry that may impact clinical/commercial viability of products.
Engage and inspire the clinical development team through communication of the strategic vision.
Lead and author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports.
Interact with Regulatory authorities at scientific advice forums.
Perform all duties in keeping with the company’s core values, policies and all applicable regulations.
Ensure data review quality and data accuracy.
Conduct safety review and follow‑up.
Interpret data and ensure CSR quality/Briefing book quality.
Interact with the HA and IRB/EC and respond to medical questions raised by EC/IRBs and sites.
Conduct literature research and competitive intelligence tracking for assigned projects.
Qualifications
MD or equivalent medical degree with advanced clinical training.
5+ years of pharmaceutical experience in Clinical Development for a Senior Medical Director.
Experience in an academic or industry environment spanning Phases I through IV.
Knowledge of Oncology required with proven ability to interpret efficacy and safety data.
Knowledge of GCP, clinical trial design, statistics, and regulatory processes.
Excellent leadership, organizational, analytical, presentation and communication skills.
Experience in biotech preferred.
Willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast‑paced environment.
Demonstrated ability to build effective working relationships, influence, negotiate and drive organizational engagement.
Superior interpersonal and communication skills ensuring alignment of cross‑functional teams.
Highly collaborative and effective influencing skills across multiple geographies.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Strategy/Planning and Project Management
Industry
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Worksite address
florham park, NJ, 07932, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.