Clinical Development Lead

Actalent; United States; Remote; USD 179,000 - 207,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Paid Time Off

Job summary

Actalent is seeking a Clinical Development Lead to drive global clinical strategies for late-stage programs. The role involves leadership of phase 1-3 development, overseeing international trials and trial teams, and authoring final study reports.

You will guide protocol development, safety mitigation, and cross-functional collaboration to advance therapeutic targets. The position is remote and offers exposure to global late-phase programs from a clinical development perspective, with frequent

Qualifications

• 7+ years in clinical research, preferably in rare diseases.
• Regulatory experience including IND and/or NDA submissions.
• Excellent written and oral English communication.

Responsibilities

• Develop and define objectives aligned with global clinical strategies, communicating with clinical staff.
• Provide strategic leadership to phase 1-3 development programs and oversee global trials and teams.
• Lead protocol development, oversee study execution, and prepare final study reports.
• Identify and address safety issues within programs and develop mitigation strategies.
• Participate in Clinical Team and Operations meetings, discussing budgets and resources.
• Evaluate emerging data to inform therapeutic area strategies and design clinical plans.
• Collaborate with cross-functional teams to explore new targets and opportunities.
• Present at academic congresses, investigator meetings, and advisory meetings.
• Contribute to regulatory submissions by authoring clinical sections of dossiers.
• Conduct due diligence by evaluating external partners' clinical strategies.

Skills

Clinical research

Regulatory submissions

English communication

Job description

Job Title: Clinical Development Lead

Job Description

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.

Responsibilities

• 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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Work Environment

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.

Job Type & Location

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

Pay and Benefits

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 jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

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

Application Deadline

This position is anticipated to close on Nov 6, 2026.

Workplace Type

This is a fully remote position.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.