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Vice President, Clinical Development

Cambridge, MA

Posted: 07/18/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2388

The Vice President, Clinical Development, in conjunction with the CMO, will lead the strategic direction of clinical programs, as well as new compounds transitioning from discovery to development, and be a key driver of our client’ s mission to urgently develop high-quality medicines. While leading a small team of clinicians, he/she will ultimately be responsible for the design and execution of clinical studies, helping to create the clinical development plans for new indications and paving a path towards regulatory approval.

The new incumbent 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. He/she will also lead and participate in teleconferences with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities (i.e. FDA and EMA), as well as with client’ s Executive Committee and the Board of Directors.

A genuine interest and understanding of the science supporting the client’ s pipeline, an ability to work collaboratively in a multidisciplinary team setting, and both a passion and personal commitment to developing new treatments for patients with cancer are all critical for success.

KEY RESPONSIBILITIES
  • Oversee a group of highly motivated clinicians responsible for the development of client’ s lead pipeline candidate and related, new experimental medicines.
  • Directly responsible for the design and review of oncology clinical study protocols from first-in-human phase 1 through phase 2 and phase 3 pivotal studies that will support registration.
  • Oversee critical ongoing clinical trials.
  • Provide strategic leadership of the existing and planned clinical programs to support global filings.
  • Facilitate the development of key internal and external documents pertaining to product development including clinical study protocols, Investigator’ s Brochures, IND and CTA submissions, clinical study reports, NDA and MAA documents, meeting abstracts and presentations, scientific journal publications, and clinical/project strategy documents.
  • Represents client at key national and international medical and scientific meetings including participation and/or leadership of advisory boards with key option leaders.
  • Provide medical review, assessment and interpretation of clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation.
  • Collaborate with the 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.
  • Work closely with Discovery on the development of novel compounds and advising on the optimal translational and clinical path.
  • Display a genuine interest and understanding of the science supporting the client’ s pipeline; an ability to work collaboratively in a matrixed, multidisciplinary team setting, and a commitment to developing new treatments for patients with cancer are critical for success.
  • Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS
  • An advanced degree such as a MD or MD/PhD with strong clinical practice and clinical research experience in Oncology and/or Hematology. Board Certification (or equivalent) in Oncology and/or Hematology is preferable.
  • Strong leadership skills and proven biopharmaceutical industry experience developing, planning, designing and executing early and late stage programs in the Oncology and/or Hematology fields. Experience with high-complexity first-in-human studies is advantageous.
  • Meaningful experience in the biopharmaceutical industry, ideally including direct experience of the drug development process and clinical science leadership of an asset from IND through NDA/MMA submission, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations and pharmacovigilance.
  • First-hand experience of treating patients with Oncological or Hematological malignancies in a clinical setting is advantageous.
  • Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities.
  • Strong working knowledge of the FDA and other regulatory organizations (e.g. EMA, PMDA).
  • Outstanding scientific knowledge applicable to Oncology/Hematology clinical research.
  • Demonstrable experience in specific study and broader development plan design, regulatory authority interaction and label negotiation.
  • Proven relationship-building skills, both internally and externally with key stakeholders and opinion leaders in the hematology-oncology fields.
  • Equally comfortable in directly running programs and indirectly by overseeing other personnel in the global environment in which the company operates.
  • Experienced and comfortable in a fast-paced entrepreneurial and dynamic setting across multiple jurisdictions.

CAPABILITIES
  • Sophisticated communication, management and leadership skills, gravitas and presence, as well as a level of comfort at influencing and negotiating both within and outside an organization.
  • 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.
  • Maintains a perspective and acting on the belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond the company.
  • Creates alignment horizontally and vertically by making a case for one’ s approach that resonates and brings people along by addressing not only facts but emotion.
  • A self-motivator with the capability of working autonomously or as part of a team with a ‘ hands-on’ approach and in a collaborative manner.
  • Natural problem-solving skills and the ability to challenge conventional thinking.
  • Innovative and persuasive individual with a pragmatic and hands-on approach.
  • Ability to strategize and lead a goal-oriented clinical development team.
  • Learning agile and ‘ scalable’, with the potential to take on broader responsibilities as company grows.
  • Fluency in the English language with excellent written English skills. Additional European languages advantageous.
  • Ability to travel domestically and internationally.

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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