Senior Medical Director, Clinical Sciences - Gene Therapy - United States
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Senior Medical Director [SMD] is responsible for leading and executing the clinical development strategy within Development Sciences. She/He is a key member of the management team charged with creating a gene therapy franchise on an accelerated timeline. This individual has a global scope of responsibility as the leader of the Medical function and has to align and provide leadership across matrix/functions pro-actively.
As the Clinical sciences lead, the SMD has ownership of the direction, design and planning, execution and interpretation of clinical trials research leading cross functional team in the preparation of CSR and publications, data collection and safety monitoring.
Responsibilities include development of Clinical Development plan with Core team, concept sheets and protocol designs beyond Phase 1, preferably Phase 0-4. CSRs, ICFs, SAPs, Safety Reviews including handling of AEs, SAEs, SUSARs, and substantial amendments. The individual will be responsible for selecting, leading and managing Clinical Advisory Boards, DRBs and DMCs.
The SMD has to provide input to Investigators' Brochures, support Regulatory Affairs in interactions with regulatory agencies worldwide and able to represent Bio Marin in such interactions, including responses to queries related to PIs and help conceptualize best pathway towards product approval.
Other critical supportive roles include support of Clinical Operations in site selections and recruitment adherence to GCP and all aspects of study conduct, Medical Affairs in development of lexicon, medical education tools and training, Business Development and Marketing in product launches across geographies . This function will represent Bio Marin at speaking engagements, advisory boards, symposia and Congresses as well as internal strategy discussions .
In addition to providing critical strategic direction for drug development, the incumbent will cultivate a close working relationship with Research and Development in order to help guide basic and strategic research efforts to better meet unmet medical needs. This also includes providing critical clinical and scientific input into the resolution of issues, when requested, arising in manufacture of these complex biological products.
- This position reports directly to the Vice President Clinical Sciences, Bio Marin Pharmaceutical Inc.
- The candidate is responsible for interpreting and evaluating results of research and making recommendations.
- She/He is responsible to see that the design and conduct of studies under her/his management are carried out with the highest medical and ethical standards with national government regulations including the U.S. FDA.
- Maintenance of expert scientific and medical knowledge is achieved, among other means, by attendance and participation at medical meetings and seminars and review of pertinent current medical and scientific literature.
- This position requires a Medical Degree (MD)
- Candidate should have considerable experience within drug development beyond Phase 1/2; therapeutic area expertise in Hematology/Hemophilia preferred, not required.
- Candidate must have demonstrated originality in problem solving as applied to drug development and have strong interpersonal skills, leadership capabilities and strong organizational skills.
- She/He must have demonstrated success in leading both internal and cross-functional project teams ad can establish credibility across a range of relevant scientific and clinical 'issues, and be able to generate and communicate a comprehensive body of clinical data related to assigned molecule/drug .
- The candidate should have both strong presentation and speaking skills.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.