Senior Director, Clinical Development (Medical Director)Position OverviewThe Senior Director, Clinical Development (Medical Director) will provide medical and scientific leadership for City Therapeutics' clinical development programs. This individual will play a central role in shaping clinical development strategy and translating innovative RNAi science into well-designed, executable clinical programs.
The successful candidate will serve as the medical lead for one or more programs, with responsibility for clinical strategy, protocol development, study execution, data interpretation, and regulatory interactions. This individual will collaborate closely with Clinical Operations, Biometrics, Pharmacology, Toxicology, Regulatory Affairs, Translational Medicine, and other cross-functional partners.
This is an opportunity for an experienced physician-scientist to have a meaningful impact within a growing biotechnology company and help advance programs from early clinical development through key milestones, and regulatory approvals.
Key Responsibilities- Provide medical and scientific leadership for one or more clinical development programs.
- Develop and execute clinical development plans aligned with overall program and corporate objectives.
- Lead the design and development of clinical development plans, clinical study protocols, including study objectives, endpoints, eligibility criteria, dose-escalation strategies, and safety-monitoring plans.
- Serve as the medical monitor for assigned clinical trials and provide ongoing oversight of participant safety, medical data, and emerging benefit-risk profiles.
- Partner closely with Clinical Operations to support high-quality and timely study execution.
- Review and interpret clinical safety, efficacy, pharmacokinetic, pharmacodynamic, and biomarker data.
- Lead or contribute to clinical study reports, investigator brochures, regulatory submissions, informed consent documents, and other clinical and regulatory materials.
- Present clinical strategy and program updates to executive leadership, governance committees, investigators, and external partners.
- Support interactions with global health authorities, including the FDA and other regulatory agencies.
- Build strong relationships with investigators, key opinion leaders, clinical research organizations, and other external partners.
- Collaborate with Biometrics to develop statistical analysis plans and ensure the quality and integrity of clinical data.
- Contribute medical expertise to translational, nonclinical, regulatory, and commercial planning.
- Identify clinical risks and recommend thoughtful, practical solutions to keep programs moving forward.
- Monitor developments in the therapeutic landscape and incorporate relevant scientific, medical, and competitive insights into clinical strategy.
- Support due diligence, business development, and external collaboration activities, as needed.
- Mentor and develop clinical team members and contribute to the continued growth of the Clinical Development function.
- Foster a culture that reflects City Therapeutics' values of Courage, Innovation, Tempo, and Yes.
Qualifications- MD or equivalent medical degree required.
- Board certification or board eligibility in a relevant medical specialty strongly preferred.
- A minimum of 6+ years of relevant clinical development experience within the biotechnology or pharmaceutical industry.
- Experience serving as a medical monitor and providing medical leadership for clinical trials.
- Demonstrated experience designing and executing early-stage clinical studies; experience supporting programs through later-stage development is highly desirable.
- Strong understanding of clinical trial design, drug development, Good Clinical Practice, and global regulatory requirements.
- Experience contributing to regulatory submissions and participating in interactions with health authorities.
- Proven ability to analyze and communicate complex clinical and scientific information clearly and effectively.
- Experience working within cross-functional development teams and influencing decisions in a collaborative environment.
- Ability to operate effectively in a fast-paced, growing biotechnology company and balance strategic thinking with hands-on execution.
- Excellent leadership, communication, organizational, and relationship-building skills.
- Experience in RNA therapeutics, rare diseases, ophthalmology, immunology, neurology, or another relevant therapeutic area is preferred but not required.
Location: This position is based in Cambridge, Massachusetts, and requires an onsite presence five days per week.
Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including relevant skills, experience, internal equity, relevant education or training and market dynamics. In addition, this role is eligible for an annual cash bonus and equity compensation. City Therapeutics offers a comprehensive and competitive benefits package including medical, dental, vision, life insurance, health and dependent care FSA accounts, HSA/HRA accounts with company contributions, in addition to a 401(k) with competitive company match. Per Year Salary Range: $255,000 to $290,000
