Group Medical Director (GMD), Tumor Dependencies, Oncology Early Development
Group Medical Director (GMD), Tumor Dependencies, Oncology Early Development AbbVie has a proven track record in hematologic malignancies, including several approved indications for Imbruvica and Venclexta. Building the oncology portfolio through the strategic development of a broad pipeline is a key focus for AbbVie. The tumor dependencies group in early oncology seeks to build upon our current presence in hematologic malignancies and help define the next generation of therapeutic advances to solidify our presence in hematologic cancers and build a presence in solid tumors. We are developing the next advances as they relate to apoptosis, cell signaling, and tumor genomic dependencies, understanding how they inter-relate to support cancer cell survival and how targeting them individually or in combination can transform therapeutic options for patients. The group medical director (GMD) is a strategic leader within OED and AbbVie oncology and a key people developer and manager within our early oncology clinical science group. The GMD is expected to partner closely with discovery, late development, commercial, and cross functionally within OED to successfully develop the next generation of tumor dependency assets for AbbVie. In this role, the GMD leads the direction, planning, execution, and interpretation of clinical trials or research activities of several clinical development programs in OED, either directly or through managing reports. The GMD participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. The role includes hiring and retaining top talent with high expectations to know and develop team members, both within the OED group and to develop talent across AbbVie. The group medical director serves as a member of the OED clinical leadership team along with other GMDs and the clinical science VP. In this capacity, the GMD helps set clinical science goals and serves as a leader of our culture:
scientifically inquisitive, creative while critical in thought, high trust while open to debate and challenge, and always fun and supportive.
Responsibilities:
Personally or through a direct report, leads and demonstrates ownership of the design and implementation of multiple clinical development programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel. Has overall responsibility for leading and mentoring clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. In partnership with safety, responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols assigned. Has primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Manages one level of Medical and Scientific Directors and/or Clinical Scientists (typically 4 to 6 in total). This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals. May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Strategy Teams (ASTs). Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. Contributes in partnership with Discovery and Precision Medicine colleagues to design and implement translational strategies. Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of an oncology fellowship is highly desirable. At least 7 years (9
years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent. Ability to run a complex clinical research program independently. Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence. Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy. Ability to interact externally and internally to support a global scientific and business strategy. Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols. Must possess excellent oral and written English communication skills. Ability to exercise judgment and address complex problems and create solutions across multiple projects.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
scientifically inquisitive, creative while critical in thought, high trust while open to debate and challenge, and always fun and supportive.
Responsibilities:
Personally or through a direct report, leads and demonstrates ownership of the design and implementation of multiple clinical development programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel. Has overall responsibility for leading and mentoring clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. In partnership with safety, responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols assigned. Has primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Manages one level of Medical and Scientific Directors and/or Clinical Scientists (typically 4 to 6 in total). This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals. May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Strategy Teams (ASTs). Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. Contributes in partnership with Discovery and Precision Medicine colleagues to design and implement translational strategies. Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of an oncology fellowship is highly desirable. At least 7 years (9
years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent. Ability to run a complex clinical research program independently. Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence. Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy. Ability to interact externally and internally to support a global scientific and business strategy. Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols. Must possess excellent oral and written English communication skills. Ability to exercise judgment and address complex problems and create solutions across multiple projects.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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