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Day One Biopharmaceuticals · 1 month ago

Senior Medical Director, Clinical Development

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$320K/yr - $350K/yr

7+ years exp

Day One Biopharmaceuticals is a mission-driven biotech company focused on advancing innovative therapies for childhood and adult diseases. They are seeking a Senior Medical Director, Clinical Development to provide medical and scientific oversight for clinical trials and ensure patient safety while collaborating with cross-functional teams to drive clinical development plans.

BiopharmaBiotechnologyHealth CarePharmaceutical

No H1B

Responsibilities

In collaboration with the broader cross-functional study and project team(s), design of clinical studies to meet the stated objectives

Drive and advance clinical and integrated development plans from FIH trial to regulatory approval for one or more indications, including life-cycle management

Be accountable for the review and amendment of clinical trial protocols

Review and approve informed consents

Provide medical input into the assessment of investigational site capabilities

Participate in the review and approval process for data capture and review

Organize expert panels, consultants, or advisor board meetings to provide input into protocol development and data analysis

Provide managerial oversight to a team consisting of Medical Directors, Clinical Scientists, and/of Fellows

Build clinical development team according to needs of the program

Protocol training for investigators

Issue resolution

Audit responses

Study conduct and closeout

Inspection readiness

Ensure development of and/or adherence to safety review plans

Perform and document regular review of individual subject safety data, and review of cumulative safety data

Working with our Drug Safety team, review individual subject data (including AEs and other safety data), SAEs, and potentially clinically important findings, as well as determine whether or not follow-up is needed

Working with our clinical scientists and biometrics colleagues, perform reviews of data generated by statistical analyses, requesting additional tables or analyses as needed

Perform reviews and procedures required for database finalization

Lead the authoring of clinical study reports

Lead the authoring of clinical sections of regulatory documents (e.g. IB, IND annual reports, etc.)

General protocol questions, questions on inclusion/exclusion, safety management, etc

Ensure answers are consistent across study regions

Support regulatory interactions, accountable for providing responses to regulatory inspection observations, internal audits, etc

Support RA updates and submissions for IND documents (IB, DSUR, protocol, etc.)

Assist with clinical sections of regulatory filings

Assist in the preparation and delivery of clinical study reports and results for internal (corporate) and external (regulatory) purposes, as well as external medical and scientific conferences and meetings

Qualification

Oncology clinical researchClinical trial designDrug development experienceGCP/ICH knowledgeMDMD/PhD degreeBiostatisticsMedical monitoringInterpersonal skillsTeam collaborationPresentation skillsOrganizational skills

Required

MD or MD/PhD degree is required

7-10 years of experience in the biopharmaceutical industry with experience in oncology drug development and design/conduct of clinical trials

Knowledge of ICH and Good Clinical Practice and familiarity with global and regional regulations

Experience in the assessment of adverse events and safety of patients participating in oncology clinical trials

Skilled in modern oncology protocol design, data interpretation, biostatistics, and medical monitoring

Strong interpersonal skills, as well as the ability to function in a team environment

Ability to lead by example, build interdependent partnerships, and participate in a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility

Able to prioritize and manage several projects simultaneously

Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines

Proven ability to develop internal relationships in a matrix environment, whether in person or remotely, as well as external relationships with Key Opinion Leaders and industry experts

Outstanding verbal, written, and presentation skills to enable effective communication at all levels that allows for the presentation of complex and/or new ideas with clarity and simplicity

A desire to be part of a highly innovative company aimed at transforming the lives of children and adults with serious, life-threatening diseases, their families and society

Exceptionally organized with keen attention to detail with the ability to shift focus and priorities when necessary, under pressure and within deadlines

Preferred

Experience in drug development for pediatric oncology and/or rare diseases

Training and experience in oncology; pediatric oncology and/or neuro-oncology experience is preferred but not essential; board certified or eligible in oncology (and/or hematology)