Director Clinical Operations

Medella Life; Boston (MA); On-site; USD 180,000 - 320,000; Full time

Job summary

Medella Life in Massachusetts seeks an experienced Director of Clinical Operations to lead oncology development programs, providing strategic clinical leadership from early‑ to late‑stage trials (Phases I–III) while maintaining hands‑on oversight and cross‑functional collaboration with Regulatory Affairs, Biostatistics, Medical Affairs and Translational Medicine.

The ideal candidate has 8+ years in clinical development within biotech/pharma, with oncology program experience and strong FDA/IND

Qualifications

• MD/PhD/PharmD or equivalent with oncology focus.
• 8+ years clinical development experience in biotech/pharma.
• Experience leading oncology programs and IND/FDA interactions.

Responsibilities

• Provide clinical leadership across oncology development programs from Phase I–III.
• Develop and execute clinical development strategies aligned with program objectives.
• Provide input on study design, endpoints, patient populations and plans.
• Collaborate with Regulatory Affairs on FDA interactions and IND submissions.
• Mentor junior team members and oversee CROs and external partners.

Skills

Oncology clinical development

Clinical trial design

FDA regulatory strategy

Cross-functional leadership

Mentorship / people leadership

Education

MD/PhD/PharmD or equivalent

8+ years clinical development experience

Job description

We are seeking an experienced Director of Clinical Operations to join a rapidly growing oncology biotechnology company based in Massachusetts.

The Clinical Director will provide clinical leadership across the company's oncology development programs, working closely with Clinical Operations, Regulatory Affairs, Biostatistics, Medical Affairs, Translational Medicine and senior leadership.

This is a highly visible role for an experienced clinical development professional who can contribute strategically to program development while maintaining hands‑on oversight of clinical studies.

The successful candidate MUST be based in Massachusetts and able to work closely with the company's Boston‑area team.

Key Responsibilities

• Provide clinical leadership across oncology clinical development programs from early‑stage development through later‑stage clinical trials (Phase I‑III).
• Develop and execute clinical development strategies aligned with overall program objectives.
• Provide clinical input into study design, protocols, endpoints, patient populations and clinical development plans.
• Work closely with Clinical Operations to ensure effective execution of clinical trials.
• Collaborate with Regulatory Affairs on FDA interactions, IND submissions and regulatory strategy.
• Support preparation for FDA meetings and provide clinical input into regulatory submissions.
• Review and interpret clinical data and provide strategic recommendations to program leadership.
• Work cross‑functionally with Biostatistics, Data Management, Pharmacovigilance, CMC, Translational Medicine and Medical Affairs.
• Support clinical trial design and execution across multiple sites and, where applicable, international geographies.
• Provide clinical oversight of investigators, CROs and other external partners.
• Identify clinical risks and opportunities and communicate recommendations to senior leadership.
• Contribute to clinical development plans, investigator engagement and scientific communications.
• Mentor and provide clinical leadership to junior members of the organization as the company continues to scale.

Qualifications

• MD, PharmD, PhD or other advanced scientific/medical degree preferred.
• 8+ years of clinical development or clinical research experience within biotechnology or pharmaceutical organizations.
• Significant experience working on oncology clinical development programs.
• Demonstrated experience supporting clinical trials from protocol development through execution and data interpretation.
• Strong understanding of clinical development strategy and FDA regulatory requirements.
• Experience working with INDs and FDA interactions strongly preferred.
• Experience collaborating with CROs, clinical investigators and external vendors.
• Strong understanding of GCP and applicable clinical research regulations.
• Ability to analyze clinical data and translate findings into clear development recommendations.
• Strong cross‑functional communication and stakeholder‑management skills.
• Previous experience leading clinical programs or managing clinical development professionals is preferred.
• Experience working within a small‑to‑mid‑sized biotech environment is highly desirable.
• Must be currently based in Massachusetts.