Medical Director

Physician Pivot; Cambridge (MA); On-site; USD 250,000 - 360,000; Full time

Job summary

Physician Pivot is seeking a Medical Director of Oncology Clinical Development to lead clinical activities for advancing the client’s portfolio. The role entails directing clinical data generation, engaging with scientific leaders, and managing external expert relationships to support regulatory approvals and lifecycle management.

The position requires MD-level credentials with board certification in oncology or related fields, extensive experience in drug development, and strong regulatory

Qualifications

• MD (or equivalent) required; board certified in medical oncology, radiation oncology, hematology or internal medicine with hematology/oncology experience.
• Experience in clinical drug development and regulatory interactions.
• Strong understanding of GCP and regulatory requirements for registration and approvals.

Responsibilities

• Collaborate with physicians, scientists, regulatory professionals and biostatisticians to develop and execute phase 1-3 interventional trials.
• Guide protocol development aligned with the Clinical Development Plan to define efficacy, safety and product differentiation.
• Oversee medical review of trial data and blinded reviews for IDMCs as needed.
• Monitor safety data with pharmacovigilance and address urgent safety questions.
• Contribute to clinical study reports and regulatory documents in collaboration with Regulatory Affairs and Medical Affairs teams.
• Develop external partnerships with thought leaders to support strategic clinical development objectives.
• Represent Clinical Development on disease-area strategy and medical affairs initiatives.

Education

MD (or equivalent)

Board certification in medical oncology / radiation oncology / hematology or internal medicine

Licensure to practice medicine in relevant jurisdiction

Knowledge of regulatory requirements and GCP

Job description

Job Purpose

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.

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

MD (or equivalent)

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

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

Preferred Qualifications Include

• M.D. PhD degree
• 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

List below any licenses, certificates, registrations

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.