Senior Medical Director, Clinical Development Hematology

APX Life Sciences; Boston (MA); On-site; USD 230,000 - 360,000; Full time

Job summary

APX Life Sciences is seeking a Senior Medical Director in hematology to lead a pivotal late-stage clinical program. This is a hands-on medical leadership role with strategic development responsibilities across operations, regulatory strategy, and scientific communications.

You will work closely with Biometrics, Regulatory, Clinical Pharmacology, and other cross-functional leaders to drive development milestones and medical decisions, shaping the hematology portfolio for future submissions.

Qualifications

• MD or MD/PhD with hematology-related clinical training.
• Significant clinical development experience in biotechnology or pharmaceutical environments.
• Experience providing medical leadership for pivotal, late-stage or registrational studies.
• Strong ability to translate scientific concepts into development and regulatory plans.
• Experience preparing for and participating in health authority interactions.
• Strong cross-functional communication and ability to work with scientific and operational stakeholders.

Responsibilities

• Provide medical leadership and accountability for the execution of a pivotal clinical study, ensuring high-quality conduct and medically sound decisions.
• Develop and execute clinical development strategy, translating questions into clear development plans and actionable recommendations.
• Lead medical interpretation of emerging and final data with cross-functional teams.
• Contribute to global health authority strategy, briefing materials, and submissions.
• Own the medical benefit-risk assessment for the program and support regulatory decisions.
• Provide study-level medical oversight, safety review, and data assessment.
• Establish relationships with investigators and clinical sites to resolve challenges.
• Support scientific strategy and external communications, including congress presentations and publications.
• Contribute to broader clinical development strategy and portfolio direction.
• Serve as a senior medical voice within the cross-functional CD organization.

Education

MD or MD/PhD with clinical training relevant to hematology

Job description

Senior Medical Director, Clinical Development - Hematology

APX Life Sciences is partnering with an innovative, clinical-stage biotechnology company developing transformative therapies for patients with serious and underserved hematologic conditions.

The organization is advancing a differentiated pipeline of therapies designed to address significant unmet needs in hematology, with a focus on developing treatments that have the potential to meaningfully improve outcomes for patients.

We are looking for a Senior Medical Director, Hematology to join the clinical development organization and play a critical role in the advancement of a late-stage clinical program.

This is a highly visible role for a physician who wants to combine hands-on medical leadership with strategic clinical development. You will have significant ownership of a pivotal clinical program, working closely with Clinical Operations, Biometrics, Regulatory, Clinical Pharmacology, and other cross-functional leaders to drive the program toward key development milestones.

The successful candidate will be close enough to the data and study execution to identify and solve medical issues early, while also operating strategically across clinical development, regulatory strategy, scientific communication, and the broader program.

What You’ll Do

• Provide medical leadership and accountability for the execution of a pivotal clinical study, ensuring high-quality study conduct and medically sound decision-making.
• Develop and execute clinical development strategy, translating scientific and medical questions into clear development plans and actionable recommendations.
• Lead the medical interpretation of emerging and final clinical data in partnership with Biometrics, Clinical Pharmacology, and other cross-functional teams.
• Contribute substantially to global health authority strategy and interactions, including preparation of briefing materials, meeting strategy, responses to regulatory questions, and clinical content for future submissions.
• Own the medical benefit-risk assessment for the program and help develop the clinical and scientific rationale supporting key development decisions.
• Provide study-level medical oversight, including medical monitoring, eligibility and protocol deviation review, data review, safety assessment, and oversight of external medical monitoring activities.
• Establish strong relationships with investigators and clinical sites, proactively identifying medical or clinical challenges and helping teams resolve them efficiently.
• Support the development of scientific strategy and external communication, including congress presentations, publications, advisory boards, and other scientific engagements.
• Contribute to broader clinical development strategy and help shape the future direction of the hematology portfolio.
• Serve as a senior medical voice within a highly collaborative, cross-functional clinical development organization.

What You’ll Bring

• MD or MD/PhD with clinical training relevant to hematology or another comparable complex therapeutic area.
• Significant clinical development experience within biotechnology or pharmaceutical environments.
• Demonstrated experience providing medical leadership for a pivotal, late-stage, or registrational clinical study.
• Strong understanding of clinical development strategy and the ability to translate scientific concepts into clinical, evidence-generation, and regulatory plans.
• Experience preparing for and participating substantively in health authority interactions.
• Strong clinical and scientific judgement, with the ability to interpret complex clinical data and translate findings into clear development decisions.
• Experience developing clinical and scientific content for external presentations, publications, regulatory interactions, and/or submission documents.
• Excellent cross-functional communication and the ability to operate effectively with both scientific and operational stakeholders.

Nice to Have

• Experience in rare or ultra-rare disease development, particularly programs involving small patient populations and complex individual patient data.
• Experience in hematology or a closely related therapeutic area.
• Experience with innovative clinical trial designs and complex clinical endpoints.
• Experience supporting a BLA, MAA, or comparable regulatory filing through submission and/or approval.
• Experience working within a growing biotech environment where teams and processes are still being built.