Medical Director

7 days ago

boston, United States Albion Rye Associates Full time

Job Title: Senior Medical Director - Oncology (ADC Biotechnology)

Location: United States - Remote


Company Overview:


We are an innovative biotechnology company at the forefront of developing next-generation antibody-drug conjugates (ADCs) targeting oncology. Leveraging our unique technology platform, we are committed to addressing critical unmet medical needs in cancer treatment, aiming to bring life-changing therapies to patients. As we transition from preclinical to clinical stages, we are seeking an experienced Senior Medical Director to lead our clinical development strategy and execution, contributing to a pipeline of transformative oncology therapeutics.


Position Overview:


The Senior Medical Director will play a critical role in driving the clinical strategy, design, and implementation of early-phase clinical trials. Reporting directly to the Chief Medical Officer (CMO), this individual will collaborate closely with cross-functional teams, including R&D, regulatory affairs, and commercial, to develop and execute a comprehensive clinical development plan. The Senior Medical Director will be responsible for providing medical leadership, ensuring patient safety, and contributing to scientific and regulatory interactions. This role requires deep expertise in oncology and ADCs, with a proven ability to work effectively in a fast-paced, early-stage biotech environment.


Key Responsibilities:


Clinical Development Strategy:

  • Lead the clinical strategy and design of early-phase oncology trials, focusing on ADC candidates from preclinical through early clinical development.
  • Collaborate with cross-functional teams to align clinical development goals with corporate objectives and regulatory requirements.
  • Provide strategic input for product development plans, including target indication selection, trial design, and overall clinical strategy.


Medical Leadership and Oversight:

  • Serve as the clinical lead on project teams, providing medical oversight, safety monitoring, and clinical input throughout the study lifecycle.
  • Ensure trial protocol compliance, data integrity, and adherence to regulatory standards across clinical development activities.
  • Act as the primary clinical point of contact with investigators, key opinion leaders, and external experts.


Regulatory and Scientific Communication:

  • Prepare, review, and contribute to regulatory submissions, including INDs, safety updates, and responses to regulatory authorities.
  • Lead or contribute to scientific presentations, publications, and advisory board discussions, positioning the company as a leader in ADC oncology.
  • Collaborate with medical affairs to support publications, congress presentations, and external educational initiatives.


Cross-Functional Collaboration:

  • Partner closely with research and development to integrate clinical and preclinical insights into program strategy.
  • Work with regulatory, commercial, and market access teams to inform product positioning and differentiation in the oncology space.
  • Mentor and guide junior clinical development team members, fostering a collaborative, patient-focused environment.


Qualifications:


Education: MD or equivalent (with a strong preference for board certification in oncology or hematology/oncology).


Experience:

  • Minimum of 7-10 years of clinical development experience in oncology, with at least 3-5 years in early-stage biotechnology or pharmaceutical companies.
  • Proven experience in ADC or immuno-oncology therapeutic areas is highly desirable.
  • Demonstrated experience leading clinical trials from concept through to regulatory submission (ideally through Phase I and Phase II).
  • Strong working knowledge of FDA and global regulatory guidelines, GCP, and other clinical development regulations.


Skills:

  • Expertise in clinical trial design, protocol development, and execution in oncology.
  • Excellent leadership, communication, and presentation skills, with the ability to engage and influence both internal and external stakeholders.
  • Strategic mindset with a results-oriented approach, adaptable to dynamic startup environments.
  • Strong scientific acumen and understanding of the oncology landscape, including competitive and emerging ADC and immuno-oncology fields.


Additional Information:


Location and Travel: This role offers flexibility in terms of work location. Travel may be required for investigator meetings, scientific conferences, and key stakeholder engagements.


Why Join Us?

This is an opportunity to be at the forefront of breakthrough oncology therapies in a high-impact, mission-driven role. If you are passionate about advancing oncology treatments and thrive in an entrepreneurial setting, we invite you to join us on our journey to bring hope and healing to patients worldwide.

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