（Senior) Medical Director-Oncology

About the role

The (Senior) Medical Director will provide strategic leadership to develop the Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Stats, and Project Management. Core responsibilities include developing and implementing the Clinical Development Plan and providing leadership to new product development from IND to submission. The position ensures program consistency and alignment across studies, working with cross-functional teams to achieve project goals within timelines and with high quality. The candidate must possess a passion for science and patients, as well as entrepreneurial drive and strong hands-on experience.

Responsibilities

• Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
• Design Comprehensive Development Plans (CDPs), clinical trials, and protocols, and execute in accordance with applicable Good Clinical Practice (GCP) regulations.
• Lead high-quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.).
• Define project timelines and deliverables, working closely with cross-functional teams to ensure completion on time, on budget, and according to the highest quality, ethical, and professional standards.
• Identify project risks with input from cross-functional teams and support resolving issues.
• Provide therapeutic area medical and scientific expertise to study teams and key stakeholders.
• Anticipate trends in medicine and industry that may impact the clinical/commercial viability of products and factor them into planning.
• Engage and inspire the project/clinical development team through communicating the strategic vision and operational plan.
• Lead and author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs, and clinical expert reports with high quality.
• Interact with Regulatory authorities (FDA, EMA, etc.) at Type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.
• Perform all duties in keeping with the company’s core values, policies, and all applicable regulations.
• Ensure data review quality (e.g., patient eligibility, Protocol Deviation review, efficacy, and safety review) and data accuracy.
• Conduct safety review and safety follow-up.
• Interpret data and ensure CSR quality/Briefing book quality.
• Interact with Health Authorities (HA) and IRB/EC, answer medical questions raised by EC/IRBs and sites, identify the need for protocol amendments, and maintain appropriate compliance with protocols.
• Interact with Principal Investigators on protocols.
• Conduct literature research and competitive intelligence tracking for assigned projects.

Requirements

• MD or equivalent medical degree is required, in addition to advanced knowledge and clinical training in a medical/scientific area.
• 5 or more years of pharmaceutical experience in Clinical Development for (Senior) Medical Director.
• Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV.
• Knowledge of Oncology is required, with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trials and proven ability to understand and interpret basic and clinical scientific research reports.
• Knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
• Excellent leadership and organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.
• Experience in biotech is 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.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Superior interpersonal and communication skills ensuring full alignment of cross-functional teams.
• Highly collaborative and effective influencing skills with the ability to operate across multiple geographies.

Location: Florham Park, NJ