What are the responsibilities and job description for the Senior Medical Director, Clinical Sciences position at Initial Therapeutics, Inc.?
Senior Medical Director, Clinical Sciences
Cambridge, MA
Hybrid
OBJECTIVES / PURPOSE
The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with serious, complex diseases.
The Senior Medical Director – Hematology, Neuroimmunology & Specialty Care (HNSC) leads and drives strategy for the overall global (US / EU / Japan / other regions and countries) clinical development for Specialty Care products, specifically focusing on development of products targeting indications in Nephrology and / or Transplant Medicine. The candidate will apply their expertise in Nephrology and / or Transplant medicine to clinical development, taking into consideration the medical, scientific, regulatory, and commercial perspectives. They will lead a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility and accountability for development decisions assessing and integrating the input from various disciplines to create and maintain a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. Applies clinical / medical decision making to clinical development processes. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.
ACCOUNTABILITIES
- Clinical Development team participation and leadership
Leads nephrology / transplant medicine clinical development for a given product and / or indication and represents Clinical Medicine on the Global (US / EU / Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.
Drives nephrology / transplant medicine clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to assoc. med directors and clinical scientists involved in these activities and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall product strategy
Responsible for medical monitoring activities, assessing issues related to protocol conduct and / or individual subject safety. Assesses overall safety information for studies and products in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
Directs activities involved in interactions with regulatory authorities / agencies and clinical development and key opinion leaders in nephrology / transplant medicine relevant to assigned products in PDT R&D. Direct interaction with PIs who are nephrologists or transplant medicine specialists in support of clinical development activities will be required. Provides leadership and serves as an advisor to the others engaged in these activities, and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.
Responsible for identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner / acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams.
Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as PDT R&D scientific content matter expert for assigned products. Represents clinical science on high impact / priority task forces across the organization or external to the company. Leads PDT R&D internal teams and global cross-functional teams, as appropriate.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :
Skills
Knowledge
LICENSES / CERTIFICATIONS :
TRAVEL REQUIREMENTS :
What Takeda can offer you :
More about us :
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
LI-hybrid
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location : Boston, MA
U.S. Base Salary Range :
256,200.00 - 402,600.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and / or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
J-18808-Ljbffr
