$325,000–$400,000 Per Year
Biostatistics, Biotech and Pharmaceutical, Brochures, Business Strategy, Cancer, Chemistry, Clinical Data, Clinical Medicine, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Communication Skills, Computer Networks, Contract Research Organization (CRO), Cross-Functional, Data Quality, Drug Development, Executive Recruiting, GCP (Good Clinical Practices), Hematology, Informed Consent, Interpret Regulations, Leadership, Medical Affairs, Medicine, Mentoring, New Drug Application, Oncology, Patient Assessment, Patient Safety, Pharmacovigilance, Presentation/Verbal Skills, Protocol Analysis, Publications, Regulations, Regulatory Compliance, Risk, Small Company, Small Molecules, Standards of Care, Startup, Strategic Planning, Team Lead/Manager, Team Player, Translational Research, Willing to Travel
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Job Type
Full-time
Description
About Us
Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs.
Role Summary
Enliven Therapeutics is seeking a highly motivated Senior Director / Medical Director, Clinical Development to provide clinical development leadership for a late-stage hematology/oncology program. This individual will play a key role in the design, execution, medical oversight, and interpretation of clinical trials, working closely with Clinical Operations, Clinical Science, Regulatory Affairs, Pharmacovigilance, Biostatistics, Translational Medicine, Medical Affairs, and external investigators.
This is a highly cross-functional and hands-on role suited for a physician with strong clinical development experience, sound medical judgment, and the ability to operate effectively in a small-company environment. The ideal candidate will bring experience supporting late-stage clinical development, a strong understanding of oncology drug development, and preferred expertise in hematologic malignancies.
Responsibilities - Areas that play to your strengths:
- Provide clinical development leadership and medical oversight for ongoing and planned clinical studies within a late-stage oncology program
- Partner closely with Clinical Scientists and cross-functional study teams to support scientifically rigorous trial execution aligned with company objectives
- Serve as a clinical development lead or senior medical lead across one or more studies, depending on experience level and program needs
- Conduct and oversee medical monitoring activities, including eligibility review, safety data review, protocol deviation assessment, and ongoing evaluation of patient-level clinical data
- Serve as a key medical point of contact for clinical trial investigators, study teams, CROs, ethics committees, steering committees, and other external stakeholders
- Lead or support peer-to-peer interactions with investigators and study site personnel
- Contribute to the design, development, and refinement of clinical trial protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and other key clinical and regulatory documents
- Collaborate with Biostatistics, Clinical Science, Clinical Operations, and Pharmacovigilance to review, interpret, and communicate emerging safety, efficacy, and benefit-risk data
- Support regulatory strategy, health authority interactions, and submission activities, including clinical sections of INDs, NDAs, briefing documents, responses to health authority questions, and related materials
- Maintain a strong understanding of the evolving hematology/oncology treatment landscape, including relevant literature, competitive programs, clinical guidelines, and emerging standards of care
- Develop and maintain productive relationships with investigators, academic experts, KOLs, cooperative groups, and patient advocacy organizations, as appropriate
- Present clinical data and program updates to internal teams, executive leadership, external advisors, and regulatory or scientific audiences
- Support publication planning, congress presentations, abstracts, manuscripts, and other scientific communications in collaboration with Medical Affairs and cross-functional partners
- Work closely with Clinical Operations and external vendors to help ensure high-quality study conduct, enrollment, data integrity, and inspection readiness
- Provide hands-on clinical development support in a lean, fast-paced company environment, including contributing beyond traditional functional boundaries when needed
- Help shape clinical development strategy, anticipate program risks, mentor junior clinical team members or consultants, and drive cross-functional alignment across late-stage execution priorities
Requirements
- MD, DO, or equivalent medical degree required
- Board certification or eligibility in oncology, hematology, hematology/oncology, or a related specialty preferred
- Minimum of 3 years of clinical development experience in the pharmaceutical or biotechnology industry. 5+ years preferred for Senior Director-level candidates. 5+ years clinical experience in academic setting strongly preferred.
- Experience supporting oncology clinical trials required; hematologic malignancy experience strongly preferred
- Late-stage clinical development experience preferred, including registrational studies, pivotal trial execution, NDA/BLA preparation, and health authority interactions
- Strong understanding of clinical trial design, execution, medical monitoring, safety review, data interpretation, regulatory expectations, and GCP requirements
- Experience contributing to clinical and regulatory documents, including protocols, amendments, investigator brochures, clinical study reports, IND/NDA materials, or briefing documents
- Ability to interpret complex clinical data and communicate implications clearly to both medical and cross-functional audiences
- Demonstrated ability to work effectively with Clinical Operations, Regulatory, Safety, Biostatistics, Clinical Science, Translational Medicine, Medical Affairs, and external investigators
- Strong leadership, collaboration, and communication skills, with the ability to influence across functions without relying on hierarchy
- Comfortable operating in a small-company environment where strategic thinking and hands-on execution are both required
- High degree of ownership, flexibility, urgency, and sound judgment
- Strong commitment to scientific integrity, patient safety, ethical conduct, and regulatory compliance
Preferred Experience
- Prior experience with hematologic malignancies, especially chronic myeloid malignancies
- Experience with late-stage kinase inhibitor or targeted therapy development
- Familiarity with global oncology development strategy and regulatory interactions
- Experience supporting advisory boards, investigator meetings, steering committees, or data monitoring committee activities
- Prior experience in a small biotech or startup environment
- Experience working with external CROs and vendors in a resource-conscious, hands-on environment
- For Senior Director-level candidates, prior experience serving as a clinical development lead, program medical lead, or significant contributor to registrational strategy
This is a full-time remote position (40 hours/week). Occasional evening, weekend, holiday, and on-call work may be required as job duties demand. Travel of around 30% may be expected for this role.
The annual salary range Enliven reasonably and in good faith expects to pay for this position at the time of this posting is $325k - $400k. The actual salary offered will be determined based on factors such as experience, qualifications, skills and expertise, geographic location, and other job-related factors permitted by law. Benefits are included and other incentives such as bonus and equity may be provided. This range is subject to change based on business needs, job scope changes, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying.
Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.
Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.