Clinical Development Director – Early Development Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the initial phase of clinical development for oncology compounds, from first-in-human trials to proof-of-concept.

• Collaborate with teams to aid in the design and execution of early phase clinical trials.

• Assist in the development of protocols, study initiation, data review, monitoring, and analysis activities.

• Contribute to formulating and executing early clinical development strategies for oncology therapeutic candidates.

• Participate in creating clinical development plans, clinical study protocols, informed consent documents, Investigator Brochures, and submissions to Ethics Committees and regulatory agencies.

• Review and assess clinical study data concerning safety, efficacy, pharmacodynamics, and pharmacokinetics.

• Aid in developing strategies and utilizing clinical biomarkers to enhance drug development.

• Work with colleagues from Precision Medicine, Research, Late Development, Regulatory, Safety, and Commercial sectors.

• Engage in evaluating external licensing or partnership opportunities in oncology therapeutic areas.

• Collaborate with external experts to offer biomedical expertise and strategic direction to oncology early development teams.

⛳️ Requirements

• MD or DO degree from a recognized medical institution.

• A minimum of 2 years of clinical research or drug development experience in an industry or academic setting.

• Board certification or eligibility in Oncology is preferred.

• Residency training in Oncology and relevant subspecialties is preferred.

• Familiarity with basic research and/or clinical trial methodologies is preferred.

• Over 3 years of pertinent drug development experience in the pharmaceutical sector and/or academia, ideally in early-stage clinical trials.

• Experience working collaboratively with pharmaceutical sponsors.

• Proficiency in designing, monitoring, and executing clinical trials while interpreting trial outcomes.

• Proven leadership capabilities and the ability to conduct studies as part of a team.

• Experience in a matrix environment and the ability to contribute to decision-making to meet demanding timelines.

• Record of publications.

• Strong interpersonal and presentation skills.

• Effective communication skills with internal stakeholders, external partners, and collaborators.

• Sponsorship for this position is not assured.

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with significant company contributions.

• Group medical, dental, and vision insurance.

• Life and disability insurance coverage.

• Flexible spending accounts.

• An annual discretionary bonus program.

• Stock-based long-term incentives.

• Award-winning vacation policies.

• Flexible work arrangements where feasible.

• Opportunities for career development.

• Emphasis on work/life balance.

• Financial planning options to save for retirement or other objectives.