Clinical Development Lead

Clinical Development Lead

We are seeking a highly skilled Clinical Development Lead who will be responsible for developing and defining both short-term and long-term objectives aligned with global clinical strategies. The ideal candidate will provide strategic leadership to phase 1-3 development programs and oversee global clinical trials and trial teams. You will lead study protocol development, oversee study execution, and develop final study reports.

Addressing safety issues, participating in clinical team meetings, and evaluating emerging medical and scientific data are integral parts of this role. Collaboration with cross-functional teams and contributing to regulatory submissions are expected. This position requires engagement with external professional bodies and staying current with scientific advancements.

• Develop and define objectives aligned with global clinical strategies, communicating effectively with clinical staff.
• Provide strategic leadership to phase 1-3 development programs and oversee global clinical trials/trial teams.
• Lead study protocol development, oversee study execution, and develop final study reports.
• Identify and address safety issues within programs, developing appropriate mitigation strategies.
• Participate in Clinical Team and Operations meetings, discussing program budgets and resource allocation.
• Evaluate emerging medical and scientific data within therapeutic areas to design clinical strategies.
• Collaborate with cross-functional teams, including nonclinical and business development, to explore new therapeutic targets.
• Present at academic congresses, investigator meetings, and advisory meetings.
• Contribute to regulatory submissions by authoring and reviewing clinical sections of submission dossiers.
• Conduct due diligence by evaluating clinical strategies and development plans of external partners.
• Engage with external professional bodies to develop key opinion leaders in therapeutic areas.
• Stay current with scientific advancements, providing training and guidance to team members.

• 7+ years of experience in clinical research, preferably within the industry and in rare diseases.
• Regulatory experience, including successful IND and/or NDA submission.
• Excellent written and oral communication skills in English.

• Preferably a relevant specialization such as immunology, hematology, or nephrology.
• Willingness to travel approximately 25% of the time for conferences, scientific advisory meetings, trial sites, and investigator meetings.

This position is remote, operating on Eastern Standard Time or Central Time. It offers a long-term opportunity to own global late-phase programs from a clinical development perspective. The work environment is dynamic, requiring high agility, creativity, and strategic thinking. You will thrive in a fast-paced, small-company environment, operating with autonomy and a hands-on approach to achieve results.

This is a Contract position based out of Lexington, MA.

The pay range for this position is $130.00 - $150.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan…