Sr./Director Clinical Development

Cambridge, MA

 Sr./Director Clinical Development 1114786

Job Scope & Purpose:

Our client is a Global company building a presence in Boston and seeing an experienced Senior Medical Director to lead the development of their compounds in all phases of development.  These efforts will enable the company to lead the clinical development in the US with a focus on Metabolic Diseases, including NASH, and (Immuno-) Oncology, but also open to other therapeutic areas. This position allows for a great deal of autonomy and leadership, working with a very experienced and impressive team.  The successful candidate will significantly contribute in expanding the Boston presence as well as the strategical and tactical product development in the clinical pipeline, overseeing clinical trial activities, and will work with company headquarters and with CROs to ensure successful study conduct to support approvals in the US and Europe (and potentially other markets), across several therapeutic areas in close collaboration with project teams.

Primary Job Responsibilities:

  • Provide strategic clinical direction and leadership on the overall development plan, regulatory requirements for clinical studies and marketing approval, risk assessments, critical issue management in the US and Europe.
  • Provide input to, or prepare TPP (Target Product Profile) & CDP (Clinical Development Plans)
  • Provide medical/clinical input on various strategic development questions across multiple indications
  • Create, or support the development of, clinical trial protocols and regulatory submissions 
  • Serve as Medical Monitor for clinical trials – Review safety data and reports, Assess causality for adverse events, Manage medical queries on study protocols. 
  • Establish and expand a network of contacts to external experts in the medical and scientific community for scientific consulting and for advisory boards
  • Prepare, implement and oversee clinical trials of all phases by closely supervising CROs and other solution providers.
  • Serve as the key contact point for his/her study portfolio.
  • Ensure that all clinical trials are conducted according to the company standards of scientific excellence, protection of study subjects, and applicable rules and regulations.
  • Develop and drive patient recruitment programs that deliver enrollment targets.
  • Be accountable to the product development teams for the quality of clinical trials conducted under the leadership of the innovation center and for meeting the milestones, enrollment targets, and budget.
  • Collaborate with other team members in the innovation center and with project teams in Korea.
  • Maintain relations with clinical trial sites, including collaborating with Principal Investigators. Support the development of presentations, handouts, and coordination of Investigator Meetings.
  • Manage escalation of study related issues and communication as appropriate.
  •  Anticipation of potential study issues and preparation of contingency plans

Primary Job Requirements: 

  • MD with clinical experience
  • Acquired or practical experience in metabolic diseases including NAFLD or NASH
  • Expert knowledge of Good Clinical Practices, FDA regulations, and relevant ICH guidance documents 
  • Professional clinical trials experience in a supervisory role, preferably in the industry
  • Demonstrated experience in clinical development plans, study protocol writing, managing or monitoring of clinical trials, as well as working and negotiating with CROs.
  • Experience in drug discovery or drug development in the field of metabolic diseases
  • Must have an entrepreneurial, self-starter mindset and ability to inspire others 

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

jprice@stratacuity.com
Code: ClinOps

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.