Senior Director of Clinical Development Oncology

Location United States
Discipline: Medical & Pharmacovigilance
Job type: Permanent
Salary: £Salary: On application
Contact name: Stuart Gilboy

Contact email: stuart.gilboy@rbwconsulting.com
Contact phone: 16179821238
Job ref: 21202(i)
Published: 29 days ago
Expiry date: 12 April 2021

​Location: Boston, MA and Remote

A pioneering drug discovery and clinical stage pharmaceutical research company, based in Boston, founded by a team of experienced scientists and executives from top global biopharmaceutical companies. The company aspires to build a world-class innovative organization with a results-oriented culture powered by scientific and clinical excellence and driven by a team of professionals with a shared accountability for success. They are recruiting a Senior Director of Oncology Clinical Development to launch a novel breast cancer study.

This is a well-funded pre-IPO biotech with a realistic plan to move forward, a broad pipeline and a powerful discovery arm producing assets for future clinical studies.

The physician (M.D. or equivalent) should share our passion for developing new treatments for cancer patients. In this remote role the clinical expert will report to the Chief Medical Officer and have primary responsibility for designing and leading the execution of human trials for clinical stage investigational products. The Medical Director will work with the CMO in collaborating across disciplines to strategically plan development programs for an expanding pipeline of novel cancer therapeutics. The Medical Director will focus on working with the clinical science team and allied corporate disciplines to drive our cancer clinical research programs to regulatory approval. The Medical Director will collaborate and coordinate with internal and external partners on the strategic development of products in China and other global markets.

As an expert leader in clinical research, the successful candidate for this position must be able to fulfill following requirements:

Essential Qualifications and Skills

  • Medical Doctor (M.D, MBBS, MBChB or equivalent) with 2+ years’ experience in the pharmaceutical industry (or related work experience).

  • Clinical specialization in oncology (advanced specialty training, U.S. board eligible/certified or foreign equivalent).

  • Candidates must be authorized to work in the U.S.

  • Hands on experience as a clinical investigator managing Phase II-III global, multi-center clinical trials in oncology, including but not limited to Europe and China, is essential.

  • Excellent oral communication skills and scientific writing experience drafting clinical study reports, abstract/poster presentations, submissions to scientific journal sub.

  • Strong interpersonal skills with the ability to work as a team player who is open minded to the diverse opinions of others.

  • Working knowledge of communicating and negotiating with IRBs/Ethics Committees and the FDA and/or other regulatory authorities.

  • Flexibility and adaptability with the ability to thrive in a dynamic, multi-national working environment.

  • Superior work ethic and a strong desire for success balanced with a commitment to personal and professional ethics.

  • Ability to exercise autonomy and leadership within a cross-functional collaborative team environment and demonstrate personal confidence balanced with humility befitting company culture.

  • Expertise and understanding of documentation needed for data collection and analysis and regulatory submission requirements, policies, and process. 


Roles and Responsibilities:

  • Provide general and specialty medical expertise at both the U.S. and global levels across the entire drug development process (IND to NDA).

  • Manage clinical scientists assigned to oncology studies/programs that you are leading and provide guidance to program team colleagues (e.g., Clinical Operations and Clinical Pharmacology)

  • With a focus on areas of interest, maintain scientific and medical expertise and knowledge of the current state of research in oncology and standards of care in domestic and global markets as well as current and evolving regulatory requirements, policies, and processes.

  • Develop and deliver expert training for internal and external programs as needed.

  • Represent Clinical Science in meetings and on committees with internal and external partners.

  • Apply leadership skills along with scientific and medical expertise to inspire internal teams and external partners to achieve corporate goals and objectives.

  • Build and develop business relationships with Key Opinion Leaders in oncology as program advisers and champions for future commercial products.

  • Collaborate with Drug Safety teams to develop Safety Management Plans, Pharmacovigilance Plans and Risk Management Plans and oversee their implementation.

  • Oversee the evaluation and interpretation of data in order to develop essential documents such as protocols and protocol amendments, clinical study reports, patient SAE narratives, and the clinical sections of registration dossier documents (e.g., ISS, ISE, and Investigator Brochure).

This is an unusual opportunity to join a pre-IPO company and consequently take part in building a successful biotech. This is a well-funded business with current revenues and likely to offer lucrative rewards in the long term.


For more information on this role please CLICK APPLY and forward your resume or email stuart.gilboy@rbwconsulting.com

Salary: On application