SENIOR MEDICAL DIRECTOR, CLINICAL DEVELOPMENT

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned.

POSITION SUMMARY:

This is an exciting opportunity at a fast-paced, growing, mission-driven biotech company with a rapidly expanding pipeline. We are seeking an experienced, motivated, and engaging physician/physician-scientist to join us as a Senior Medical Director, Clinical Development. Reporting to our Chief Medical Officer, the successful candidate will be responsible for providing medical and scientific expertise and oversight for clinical trials. The incumbent will serve as the primary accountable person for the design, execution, monitoring, delivery, and reporting of one or more early and/or late-stage clinical studies.

Additional study level activities include acting as the Medical Monitor for clinical trials, ensuring patient safety, and providing medical guidance during the design, execution, and reporting of clinical studies. In addition to study-level activities, this individual will also engage in program-level activities, including authoring/reviewing safety and efficacy summaries, clinical overviews, investigator brochures, risk management plans, periodic safety updates, and clinical sections of product labels.

The Senior Medical Director, Clinical Development will also be responsible for presenting study results to internal and external committees or advisory boards, as well as preparing data for presentation at international scientific meetings and publications. This person will will collaborate with the DAY301 Product Team Lead, leveraging their knowledge, experience, and skills to advance our PTK7-directed antibody-drug conjugate, DAY301, currently in Phase 1. This individual will lead the Clinical Development Sub-Team within the Product Team, working closely with the Product Team Lead and Program Management to ensure cross-functional execution and alignment.

Strong preference for candidates in the San Francisco Bay Area or Greater Boston area who can work a hybrid schedule with regular in-office days; however, remote opportunities may be considered. This position is subject to travel 25% for in person meetings and major conferences.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The areas of specific responsibility and attention will include, but are not limited to, the following:

• Clinical Trial Strategy and Design
  • 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 oversight and leadership to the study/program clinical development team
  • 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
• Provide Study Team with Medical Expertise
  • Protocol training for investigators
  • Issue resolution
  • Audit responses
  • Study conduct and closeout
  • Inspection readiness
• Provide accountability for safety across studies
  • 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
• Study Level Data Review
  • 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.)
• Answer and Resolve Medical and Safety Questions from Sites
  • General protocol questions, questions on inclusion/exclusion, safety management, etc.
  • Ensure answers are consistent across study regions
• Interact with Regulatory Authorities and Internal Regulatory and QA Groups on a Study Level
  • 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
• Presentations and Publication of Clinical Trial Results
  • 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

QUALIFICATIONS

The Senior Director, Clinical Development must be a natural leader with expertise in oncology clinical research. This individual will have proven experience in leading and collaborating with teams and individuals across various functions in a fast-paced, global environment. Experience in drug development for pediatric oncology and/or rare diseases would be preferred but not required. A solid understanding of early- and late-stage drug development and clinical research conducted under GCP/ICH is essential.

More specifically, it is anticipated that the ideal candidate will possess:

• 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
• 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)
• 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.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

INTERVIEW INTEGRITY

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.

COMPENSATION AND BENEFITS

The salary range for this position is $320,000 - $350,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

DISCLAIMER

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.