Medical Director, Clinical Development

Ultimate Source Recruiting; San Francisco (CA); On-site; USD 250,000 - 350,000; Full time

Job summary

Ultimate Source Recruiting is seeking a Medical Director, Clinical Development - Oncology for a biopharmaceutical client advancing next-generation biologic therapeutics in oncology and other serious diseases. You will shape clinical strategy and oversee trials from early investigation through late-stage development.

The ideal candidate brings 5–8 years of oncology drug development experience, strong medical monitoring skills, and a track record in global programs with solid tumor focus.

Qualifications

• MD or MD/PhD with board eligibility in Medical Oncology or Hematology.
• 5–8 years of pharma/biotech oncology drug development with medical monitoring responsibilities.
• Experience designing, executing, and overseeing both early- and late-stage clinical trials.
• Demonstrated ability to contribute to global clinical development strategies and cross-functional execution.

Responsibilities

• Contribute to clinical development strategies and execution plans across oncology programs.
• Provide medical leadership within cross-functional teams and align activities with program objectives.
• Collaborate with investigators and key opinion leaders to inform development decisions and study design.
• Lead or contribute to safety oversight and regulatory submissions with health authorities.
• Present data at conferences and prepare publications to communicate findings.

Skills

MD/PhD

Oncology drug development

GCP/ICH knowledge

Regulatory submissions

Cross-functional leadership

Education

MD or MD/PhD

Board certification in Medical Oncology or Hematology

Job description

Our client is an innovative biopharmaceutical company advancing next-generation biologic therapeutics across oncology and other serious diseases. Its research and development capabilities span multiple antibody-based modalities, with an emphasis on translating novel therapeutic approaches into clinical development.

The company is seeking a Medical Director, Clinical Development - Oncology to help advance its oncology pipeline across Phase I-III clinical development. This individual will play a key role in shaping clinical strategy, overseeing clinical trials, interpreting emerging data, and supporting regulatory development. Working collaboratively across Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, and Drug Safety, the Medical Director will contribute to programs from early clinical investigation through late-stage development.

The ideal candidate will bring substantial oncology drug development experience, strong medical monitoring capabilities, and a track record of contributing to global clinical development programs. Expertise in solid tumors is strongly preferred, with additional experience in hematologic malignancies, particularly multiple myeloma, considered valuable.

Key Responsibilities

Clinical Development Strategy

• Contribute to clinical development strategies and execution plans across multiple oncology programs and indications.
• Provide medical and scientific leadership within cross-functional development teams, aligning clinical activities with program objectives.
• Support geographic development planning, site selection, investigator engagement, and relationships with key opinion leaders, clinical investigators, professional societies, and patient advocacy organizations.
• Evaluate emerging clinical and scientific data to inform development decisions and future study design.

Clinical Trial Leadership and Medical Oversight

• Provide medical oversight of clinical studies, including ongoing assessment of safety, efficacy, and emerging clinical data.
• Lead or contribute to Safety Review Committees, Steering Committees, and other clinical governance activities.
• Direct the development and review of clinical protocols, Investigator Brochures, and related study documentation.
• Partner with Clinical Operations and other functional teams to support high-quality trial execution, resolve clinical issues, and maintain study timelines.
• Contribute medical expertise to the planning and implementation of early- and late-stage clinical trials.

Clinical Data Interpretation and Scientific Publications

• Collaborate with Biostatistics on statistical analysis planning and interpretation of clinical trial results.
• Evaluate clinical findings and translate data into meaningful development recommendations.
• Lead or contribute to Clinical Study Reports, scientific abstracts, congress presentations, and peer-reviewed manuscripts.
• Communicate clinical findings clearly to internal stakeholders and external scientific audiences.

Regulatory Affairs and Patient Safety

• Partner with Regulatory Affairs to develop regulatory strategies and support interactions with health authorities, including the FDA and international regulatory agencies.
• Contribute medical and scientific content to regulatory submissions, including INDs and, where applicable, NDA and BLA filings.
• Collaborate with Drug Safety and Pharmacovigilance to evaluate emerging safety information and support ongoing benefit-risk assessments.
• Participate in safety oversight activities, including Data Monitoring Committee support, as appropriate.
• Contribute to periodic safety reporting and other required regulatory documentation.

Scientific Engagement and Cross-Functional Collaboration

• Represent the organization at scientific congresses, investigator meetings, and other relevant medical forums.
• Present and discuss clinical data with investigators, key opinion leaders, and other external stakeholders.
• Support scientific communications and provide clinical development expertise for business development evaluations and other external-facing activities.
• Build productive relationships across internal functions to facilitate timely, informed clinical development decisions.

Required Qualifications

• M.D. or M.D./Ph.D. degree.
• Board certification or eligibility in Medical Oncology, Hematology, or a related specialty is preferred.
• Approximately 5-8 years of pharmaceutical or biotechnology industry experience in oncology drug development, with substantial medical monitoring responsibilities.
• Experience contributing to the design, execution, and oversight of both early- and late-stage clinical trials.
• Demonstrated ability to contribute to global clinical development strategies and cross-functional program execution.
• Working knowledge of clinical development and regulatory requirements, including GCP, ICH guidelines, and applicable health authority expectations.
• Experience supporting regulatory submissions and interactions with health authorities.
• Strong scientific writing, data interpretation, presentation, and communication skills.
• Ability to operate effectively in a collaborative, fast-paced biotechnology environment.

Preferred Qualifications

• Clinical expertise in solid tumor oncology, with additional experience in hematologic malignancies, particularly multiple myeloma, highly desirable.
• Experience with innovative therapeutic modalities, such as antibody-drug conjugates, bispecific antibodies, immuno-oncology agents, or cell therapies.
• Direct involvement in regulatory submissions, including INDs and later-stage marketing applications.
• Familiarity with biomarker-driven clinical development and translational medicine.
• Prior clinical practice experience caring for patients with cancer.
• Experience supporting global clinical programs and engaging with investigators and key opinion leaders across geographies.

This position offers the opportunity to contribute directly to oncology clinical development within an innovative biotechnology environment. The successful candidate will work closely with multidisciplinary teams and help advance clinical programs from early investigation through later stages of development.