Consultant: Clinical Development

About the role:

A stealth mode biotech company is looking for an experienced Clinical Development Consultant, part time (20 hours/week) to advise on clinical strategy. The consultant will give strategic input on clinical development plans, trial design, and program priorities as the company moves its programs toward and into the clinic. The consultant will work closely with company leadership and internal teams, and will help select and oversee external clinical development partners and

CROs. They may also take part in interactions with regulatory authorities, clinical investigators, and other external stakeholders. This is a chance to shape the clinical path of new drugs for patients at an early-stage therapeutics company backed by highly regarded investors.

Key responsibilities:

• ● Advise on clinical development strategy, program priorities, and development plans across the company's portfolio
• ● Provide input on clinical trial design, including study objectives, endpoints, patient populations, dose selection, and overall development approach
• ● Advise on clinical, regulatory, and operational considerations relevant to development, including first-in-human and early-phase clinical studies
• ● Review and provide strategic input on scientific data and clinical development materials, including clinical development plans, protocols, investigator materials, and regulatory documents
• ● Advise on the selection, oversight, and engagement of clinical development partners and
• CROs
• ● Participate in meetings with company leadership, regulatory authorities, clinical investigators, and external development partners, as requested
• ● Work with internal teams to integrate nonclinical, translational, CMC, and regulatory considerations into clinical development planning
• ● Provide additional strategic clinical development advice and subject-matter expertise as reasonably requested by the company
• ● Work closely with scientists and operators in a fast-paced biotech startup environment, operating effectively with a high degree of autonomy

Qualifications:

• ● MD, PhD, PharmD, or equivalent advanced degree in a relevant scientific or medical field, with 15+ years of relevant industry experience in clinical development preferred
• ● Proven track record of developing and executing clinical development strategies, from IND through early- and later-stage clinical trials
• ● Experience designing clinical trials, including selection of endpoints, patient populations, and dosing strategies
• ● Experience developing biologics, including antibody or antibody-conjugate programs, strongly preferred
• ● Experience selecting and managing clinical CROs and other external development partners
• ● Experience with IND submissions and regulatory interactions with the FDA and other agencies; experience with international regulatory strategy is a plus
• ● Strong relationships with clinical investigators and key opinion leaders in relevant therapeutic areas preferred
• ● Strong written and verbal communication skills, with the ability to synthesize complex scientific and clinical data into clear recommendations for leadership
• ● Experience advising or working within small, fast-paced biotechnology companies preferred

What we offer:

• ● Competitive consulting compensation
• ● A flexible engagement with a collaborative, small team
• ● The opportunity to contribute to innovative drug development efforts at an early-stage biotechnology company backed by highly regarded investors

Location:

Cambridge, MA (Remote / Hybrid flexible)