Senior Medical Director, Clinical Development

  • Location:Cambridge, MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Executive

 

Covid- 19 Mandatory Vaccination Requirement

Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

 

SUMMARY:
Surface Oncology is seeking a talented, independent, and motivated clinician to help build their clinical development group.  You will join a small but growing clinical development group contributing to the medical function, including designing, implementing, and communicating global clinical development plans for our immuno-oncology programs. You will serve as an internal and external clinical leader, including interactions with key academic advisors, principal investigators, patient groups, regulatory authorities, academic and industry collaborators as well as Surface’s senior management and Board of Directors.

This role reporting to the CMO and includes being a thought partner with other physicians within the clinical group and the SVP of Clinical Development for innovative oncology development strategies, as well as a collaborator with preclinical and translational researchers focused on development of novel immuno-oncology therapeutic agents. This position also offers the opportunity to take on a leadership role in a rapidly growing organization.

 

RESPONSIBILITIES:

  • Provide oncology drug development expertise to a rapidly expanding oncology portfolio, all developed and discovered within Surface.
  • Provide sound clinical development guidance to key stakeholders across Surface.
  • Ensure that scientific rigor and innovation continues to be integrated into and drives Surface’s oncology development strategies.
  • Excellent scientific standing among peers and the ability to address issues with a very high level of scientific rigor and creative solutions.
  • Adeptly translate oncology development program strategies into clinical study concepts that can be executed without compromising the scientific rigor of the study.
  • Assist in driving the timely execution of multiple assets and studies within the oncology portfolio.
  • Ensure excellence in both strategy and execution by partnering closely with clinical operations, biostatistics, data management, program management, and research colleagues.
  • Work closely with regulatory leaders to support regulatory submissions and develop regulatory strategies.
  • Responsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports.
  • Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators: CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials.
  • Responsible for analysis of clinical data, including safety monitoring in collaboration with PV.
  • Develop and maintain relationships and serve as medical liaison with key opinion leaders and PIs.
  • Organize and present at relevant clinical advisory boards, DMC’s and medical/scientific meetings.
  • May be expected to represent Surface at joint development committee as well as with global regulatory agencies(s)
  • Demonstrated capability to lead cross-functional teams.
  • Able to provide leadership and mentor more junior members of the clinical development team.
  • Able to present Surface programs to external parties and contribute as needed to business development efforts.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS: 

  • M.D. or D.O. degree and experience managing oncology trials required; board certification/eligibility in oncology is strongly preferred.
  • Hands-on oncology or I/O drug development experience within industry oncology in pharmaceutical and/or biotech company setting either for small molecules or large molecules
  • Proven clinical development strategist with hands-on experience with designing, implementing, and conducting clinical trials.
  • Knowledge of carrying out oncology clinical trials, including knowledge of current treatment landscapes.
  • Strategic leadership and tactical skills, excellent initiative, and judgment, and demonstrated ability to positively represent the goals of Surface.
  • Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators.
  • Proven track record of strong collaboration skills and the ability to partner with others to implement innovative oncology development strategies
  • Ability to communicate and work independently with scientific/technical personnel with excellent oral presentation skills.
  • Ability to think critically and demonstrated troubleshooting and problem-solving skills.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

EDUCATION:

  • M.D. or D.O. with expertise in Oncology or other related area, with at least 5 years’ experience working in the biotech and/or pharmaceutical industry; MD/PhD is a plus