Posted in Other 30+ days ago.
Type: Full Time
The Clinical Development group at Alkermes is located in Waltham, MA. Functions include Clinical Science, Clinical Research Scientists, Translational Medicine & Clinical Pharmacology, DMPK & BA and Medical Writing. Drug Safety and Pharmacovigilance, Statistics, and Clinical Operations are also located in Waltham. The group is tasked with designing and conducting clinical trials (Phases I-IV; domestic and international) aligned with corporate strategy, and analyzing and communicating study results.
The Clinical Development Group collaborates closely and maintains excellent working relationships with various internal groups, including Preclinical Science, Regulatory Affairs, Business Development, and New Product Planning. Clinical programs are developed in conjunction with input from external subject matter experts and consultants, and are executed through partnerships with clinical research organizations.
Clinical Development is composed of a 'hands-on' group of dedicated professionals. Team members work flexibly and collaboratively together in a matrix environment, with a high degree of personal accountability for the success of novel and aggressive clinical programs and timelines.
Position Summary
This physician's primary responsibility will be to advance the company's immune-oncology program. In addition, this physician will help advance early stage compounds into the clinic.
Key responsibilities for the Medical Director/Senior Medical Director include:
- Accountability for the building clinical development strategic planning and execution (including study design, method selection, etc) of Phase I through IV global clinical trials
- Analyze and interpret data expertly, and clearly communicate results both internally and externally.
- Lead clinical related topics/meetings and creation of slide decks for internal and external use.
- Contribute and help lead with cross functional teams competitive landscape review
- Oversee ongoing medical monitoring of clinical trials.
- Providing scientific and clinical oversite internally and to CRO and other external vendors
- Contributing to, reviewing, and approving clinical regulatory documents (clinical study reports, regulatory submission sections, investigator's brochures, etc.)
- Contributing reviewing approving scientific materials for publications, poster, abstracts
- Working collaboratively with Medical Affairs, Biostatistics and Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs.
- Building relationships with external investigators in collaborations with medical affairs staff to lead and support advisory boards and scientific advisor committees
- Working with global health authorities (eg. FDA, EMEA)
- Mentoring and supporting junior team members and clinical research scientist in career development, and providing guidance and opportunity for their professional development.
Minimum Education & Experience Requirements:
- MD with expertise in Oncology, required
- A minimum of three years' experience working in biopharma clinical development
- A total of at least six years working in clinical research or clinical development, either in biopharma or academia.
- Direct experience interacting with regulatory authorities.
- Experience across all phases of clinical trials is preferred.
Knowledge/Skills Needed:
- Excellent verbal and written communication skills, a strong scientific background with industry drug development experience, and strong team leadership skills are required.
- Ability to work in a team environment with both internal and external (CRO) members.
- Experience in Clinical trial design, especially phase 1 and proof of concept studies.
- Familiarity with biostatistical principles used in the analysis and interpretation of clinical trial data
- Familiarity with thought leaders.
- Domestic and international travel (up to approximately 25%) is required.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
#LI-PM1
Experience Level:
Director
.
|
Thermo Fisher Scientific |
|
Thermo Fisher Scientific |
|
Thermo Fisher Scientific |