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Senior Director, Clinical Development

Cambridge, MA

Posted: 07/23/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2384

This is an excellent opportunity for a physician with experience in oncology clinical development to work within a rapidly growing company. The Senior Director, Clinical Development is responsible for designing and executing clinical studies, helping to create the clinical development plan for new compounds, and to pave a path towards regulatory approval. Our client' s  pipeline is currently focused in research and early clinical development; therefore, the physician will work closely with scientists in discovery research and translational medicine, as well as non-clinical safety, DMPK/clinical pharmacology, biostatistics, clinical operations, and commercial development. The physician will also lead and participate in teleconferences with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities. The physician will interact closely with the company management team. A genuine interest and understanding of the science supporting the client' s pipeline, an ability to work collaboratively in a highly matrixed, multidisciplinary team setting, and a commitment to developing new treatments for patients with cancer are critical for success.

Responsibilities:
  • Hands-on involvement in the design and writing of oncology clinical study protocols from first-in-human phase 1 through phase 2 and phase 3 pivotal studies that will support regulatory approvals
  • Medical monitor for multiple ongoing clinical trials, including evaluation of clinical and laboratory data, assessing safety, responsibility for dose escalation decisions in phase 1, and assessing early pharmacodynamics and clinical signals of activity
  • Writing clinical sections of key documents, including Investigator’ s Brochures, IND summary documents, CTAs for initiation of studies ex-US, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs
  • Leading regular teleconferences with academic clinical investigators
  • Attending and supporting clinical site initiation visits
  • Provide strategic leadership in the existing and planned clinical programs to support global filings
  • Provide medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
  • Work closely with the client' s  R&D team, regulatory affairs, and consultants to assure timely filing of all clinical applications
  • Work closely with Pharmacovigilance on development of Risk Management Plans
  • Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws
  • Serve as the clinical face of the company both internally and externally, including the scientific community and key opinion leaders

Qualifications:
  • An M.D., D.O., N.P., P.A. or comparable advanced practice degree, with experience in adult or pediatric oncology, hematology, or rare diseases
  • Strong leadership skills and proven biopharmaceutical industry experience developing, planning, designing and executing early and late stage programs. Experience with high-complexity first-in-human studies is highly desired
  • 5 years of experience in the biotechnology or pharmaceutical industry including direct experience leading Thorough understanding of the drug development process from IND through NDA, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations and pharmacovigilance
  • Experience leading the clinical aspects of interactions with Regulatory Authorities, such as FDA and EMA.
  • Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
  • Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders
  • Ability to travel domestically and internationally, approximately 25%
  • At home in a results-driven, highly accountable environment where you can make a clear impact
  • A team player, who listens effectively and invites response and discussion

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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