Medical Director

Lancesoft; Cambridge (MA); On-site; USD 260,000 - 380,000; Full time

Job summary

The Medical Director Oncology Clinical Development at Lancesoft will report to the Executive Medical Director and drive clinical research to advance the client’s oncology portfolio. The role includes leading medical dialogues with key external experts and guiding data generation across phase 1-3 trials, ensuring scientific rigor and regulatory alignment.

This physician-lead role requires extensive experience in oncology clinical development, with strong knowledge of GCP principles and

Qualifications

• MD (or equivalent) required with board certification in oncology or related field.
• Licensure to practice desirable in the respective jurisdiction.
• Strong knowledge of clinical drug development and regulatory requirements.

Responsibilities

• Develop and execute phase 1-3 interventional clinical trials.
• Ensure high-quality protocol development aligned with the Clinical Development Plan.
• Lead end-to-end data generation and regulatory submission activities.
• Review safety data and collaborate with pharmacovigilance.
• Prepare clinical study reports and regulatory documents.
• Engage with external medical experts and thought leaders.
• Represent Clinical Development on disease-area strategy teams.
• Lead medical dialogues with scientific and medical leaders.

Skills

Oncology clinical trials

Clinical development

GCP knowledge

Medical leadership

Education

MD (or equivalent)

Board certification in oncology/related field

MD with advanced degree (PhD/MBA/MPH)

Job description

The Medical Director Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of the client’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts.

This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.

Key Responsibilities

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Ensure high-qualityy protocol development aligned with the Clinical Development Plan to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
• Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee blinded review of data packages intended for IDMCs.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
• Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of the client’s vision.
• Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
• Serve as a core member of the Clinical Matrix Team for one or more assets in development.
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
• Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.

Knowledge/Education Required

Minimum Level of Education Required

Area of Specialization

MD (or equivalent)

board certification or board qualifications in medical oncology, radiation oncology, hematology or internal medicine (with hematology or oncology experience)

Preferred Level of Education

Area of Specialization

MD (or equivalent) plus other relevant advanced or Master’s level degree (e.g., PhD, MBA, MPH etc)

Licensure to practice medicine in the respective jurisdiction of the candidate is desirable

Previous Experience Required

Basic Qualifications Include:

• 3+ years of experience in pharmaceutical/biotechnology industry or related clinical experience
• Documented academic and/or clinical research publication history or history of medical practice in a relevant field.
• Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
• Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles

List below any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.

Preferred Qualifications include:

• 5+ years of experience in pharmaceutical industry or related clinical experience
• Experience in leading oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development process
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution