Senior Medical Director, Clinical Development

Job Title:

Senior Medical Director, Clinical Development

Location:

Hybrid - Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote considered.

Role Overview :

The Senior Medical Director of Clinical Development plays a key role in the execution and operational oversight of clinical trials, ensuring high-quality data generation to support the safety and efficacy of our pipeline products. This role involves supporting clinical study design, implementation, and data interpretation while working cross-functionally to align clinical activities with overall development plans. The Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives.

Key Responsibilities:

* Clinical Trial Design and Oversight:

* Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods

* Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines

* Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug

* Authors and contributes to clinical and non-clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)

* Medical Expertise:

* Provides medical expertise of the therapeutic area, disease state, and potential drug effects

* Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team

* Stays current with relevant medical literature and clinical trial methodologies

* Contributes medical expertise to external interactions with collaborators throughout the clinical development cycle

* Cross-Functional Collaboration:

* Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to help ensure optimization of the clinical development process

* Presents clinical data to internal and external stakeholders

* Strategic Leadership:

* Contributes to the overall clinical development strategy

* Helps to identify critical clinical development milestones and helps the team to drive toward meeting or exceeding timelines

* Leads the clinical contribution for clinical study reports, clinical documents and regulatory submissions

* May oversee the work of Clinical Scientists working on the same or other programs

Qualifications:

* Medical degree (MD) with board certification in a relevant specialty

* Extensive experience in clinical research and development, ideally within the pharmaceutical industry

* Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements

* Excellent communication, leadership, and analytical skills

Compensation:

* An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.

* The anticipated salary range for candidates, who will work in Waltham, MA, is $294,000 to $330,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.